Page last updated: 2024-12-04

aminolevulinic acid

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Description

Aminolevulinic Acid: A compound produced from succinyl-CoA and GLYCINE as an intermediate in heme synthesis. It is used as a PHOTOCHEMOTHERAPY for actinic KERATOSIS. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

5-aminolevulinic acid : The simplest delta-amino acid in which the hydrogens at the gamma position are replaced by an oxo group. It is metabolised to protoporphyrin IX, a photoactive compound which accumulates in the skin. Used (in the form of the hydrochloride salt)in combination with blue light illumination for the treatment of minimally to moderately thick actinic keratosis of the face or scalp. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

FloraRankFlora DefinitionFamilyFamily Definition
GlycinegenusA non-essential amino acid. It is found primarily in gelatin and silk fibroin and used therapeutically as a nutrient. It is also a fast inhibitory neurotransmitter.[MeSH]FabaceaeThe large family of plants characterized by pods. Some are edible and some cause LATHYRISM or FAVISM and other forms of poisoning. Other species yield useful materials like gums from ACACIA and various LECTINS like PHYTOHEMAGGLUTININS from PHASEOLUS. Many of them harbor NITROGEN FIXATION bacteria on their roots. Many but not all species of beans belong to this family.[MeSH]

Cross-References

ID SourceID
PubMed CID137
CHEMBL ID601
CHEBI ID17549
SCHEMBL ID8243
MeSH IDM0000951

Synonyms (103)

Synonym
aminolevulinic
AC-054
BIDD:GT0260
AB00053763-08
AB00053763-07
5-ala
delta-ala
CHEBI:17549 ,
aminolevulinic acid
dala
DIVK1C_006954
SPECTRUM_001582
einecs 203-414-1
ccris 8958
SPECTRUM5_001505
D07567
BSPBIO_003407
MLS001333098
smr000857229
MLS001333097
aladerm
pentanoic acid, 5-amino-4-oxo-
levulinic acid, 5-amino- (8ci)
levulinic acid, 5-amino-
kerastick
pentanoic acid, 5-amino-4-oxo- (9ci)
5-aminolevulinic acid
5-amino-4-oxovaleric acid
106-60-5
5-amino-4-oxopentanoic acid
C00430
5-amino-levulinic acid
5-AMINO-LEVULINATE ,
delta-aminolevulinic acid
5-aminolevulinate
5-amino-4-oxo-pentanoic acid
DB00855
KBIO2_002062
KBIO2_007198
KBIO3_002627
KBIOSS_002062
KBIOGR_001176
KBIO1_001898
KBIO2_004630
SPECTRUM2_001662
SPBIO_001843
SPECPLUS_000858
SPECTRUM3_001654
SPECTRUM4_000618
NCGC00178086-01
5-aminolaevulinate
delta aminolevulinic acid
acid, delta-aminolevulinic
acid, aminolevulinic
35BEC718-C970-426A-9859-BF58284C60B4
bdbm50240386
.delta.-aminolevulinic acid
CHEMBL601 ,
LMFA01100055
4-oxo-5-amino-pentanoic acid
A801471
AKOS003587520
HMS3259E22
HMS2231I19
aminolevulinate
unii-88755taz87
88755taz87 ,
bf-200 ala
.delta.-aminolevulinic acid [mi]
aminolevulinic acid [who-dd]
5-aminolevulinic acid [mart.]
methylaminolevulinate hydrochloride impurity b [ep impurity]
aminolevulinic acid [vandf]
d-aminolevulinic acid
HMS3369O14
gtpl4784
FT-0620021
NC00601
SCHEMBL8243
DTXSID8048490 ,
AB00053763_09
AB00053763_10
mfcd00044485
CS-W000450
5-aminolaevulinic acid
SBI-0206721.P001
amino-levulinic acid
5-amino-4-oxo-pentanoate
5-amino-4-oxovalerate
HY-W000450
aminolevulinic acid;ala;5-amino-4-oxopentanoic acid;5-amino-4-oxo-pentanoic acid;5-amino-4-keto-valeric acid
BCP23830
AS-30950
Q238474
5-aminolevulinic-acid
FVT ,
5-azanyl-4-oxidanylidene-pentanoic acid
NCGC00178086-06
acido 5-aminolevulinico
dtxcid4028464
d-amino-levulinic acid
5-aminolevulinic acid (mart.)
EN300-101562

Research Excerpts

Overview

5-Aminolevulinic acid (5-ALA) is a key intermediate of heme biosynthesis, which is an essential component of the respiratory chain. 5-aminolevulusic acid is a protoporphyrin IX precursor used for photodynamic diagnosis.

ExcerptReferenceRelevance
"5-Aminolevulinic acid (ALA) is a key intermediate of heme biosynthesis, which is an essential component of the respiratory chain. "( Nutritional Factors That Affect the Formation of 5-Aminolevulinic Acid, a Key Intermediate of Heme Biosynthesis.
Imi, Y; Shibata, K, 2021
)
1.59
"5-Aminolevulinic acid is a new-generation photosensitizer with high tumor specificity. "( Current status of photodynamic technology for urothelial cancer.
Fukuhara, H; Furihata, M; Hanazaki, K; Inoue, K; Karashima, T; Kurabayashi, A; Lai, HW; Ogura, SI; Yamamoto, S, 2022
)
1.44
": 5-Aminolevulinic acid (5-ALA) is a naturally synthesized amino acid present in most plants as well as animals, and it is routinely consumed by humans. "( Therapeutic potential of 5-aminolevulinic acid and sodium-ferrous citrate for viral insults: relevance to the COVID-19 crisis.
Chatziantonio, C; Negoro, H; Razzaque, MS, 2022
)
1.58
"5-Aminolevulinic acid (5-ALA) is an oral agent that has been increasingly adopted in fluorescence-guided resection of HGG."( A Novel 5-Aminolevulinic Acid-Enabled Surgical Loupe System-A Consecutive Brain Tumor Series of 11 Cases.
Amankulor, NM; Andrews, E; Habib, A; Jaman, E; Ozpinar, A; Zhang, X; Zinn, PO, 2022
)
1.68
"5-aminolevulinic acid is a protoporphyrin IX precursor used for photodynamic diagnosis. "( Photodynamic diagnosis-assisted transurethral resection using oral 5-aminolevulinic acid decreases residual cancer and improves recurrence-free survival in patients with non-muscle-invasive bladder cancer.
Harada, S; Honda, T; Kani, N; Kato, T; Matsuoka, Y; Okazoe, H; Sugimoto, M; Taoka, R; Tohi, Y; Tsunemori, H; Ueda, N; Yamasaki, M, 2022
)
1.68
"5-Aminolevulinic acid (ALA) is a natural precursor of the heme biosynthetic pathway, which when exogenously administered leads to the accumulation of the photoactivatable protoporphyrin IX."( Daylight-PDT: everything under the sun.
Beiki, D; Eggleston, IM; Pourzand, C, 2022
)
1.28
"5-Aminolevulinic acid (ALA) is an intraoperative molecular probe approved for fluorescence-guided resection (FGR) of high-grade gliomas to achieve maximal safe tumor resection. "( Inhibition of ABCG2 transporter by lapatinib enhances 5-aminolevulinic acid-mediated protoporphyrin IX fluorescence and photodynamic therapy response in human glioma cell lines.
Chandratre, S; Chen, B; Howley, R; Mansi, M, 2022
)
1.69
"5-Aminolevulinic acid (5-ALA) is a natural amino acid and a precursor of heme and chlorophyll. "( 5-Aminolevulinic Acid-Induced Protoporphyrin IX Fluorescence Imaging for Tumor Detection: Recent Advances and Challenges.
Harada, Y; Murayama, Y; Otsuji, E; Takamatsu, T; Tanaka, H, 2022
)
2.16
"5-Aminolevulinic acid (5-ALA) is an intermediate in haem biosynthesis and has anti-apoptotic, anti-inflammatory, antioxidant, and other pharmacological effects. "( Effects of 5-aminolevulinic acid on the inflammatory responses and antioxidative capacity in broiler chickens challenged with lipopolysaccharide.
Chen, J; Gu, H; Li, C; Liu, G; Wang, H; Wang, S; Wu, Z, 2022
)
1.81
"5-aminolevulinic acid (5-ALA) is a proagent developed for fluorescent-guided surgery for high-grade glioma patients associated with a significant increase in resection conferring survival. "( Utility of 5-ALA for resection of CNS tumours other than high-grade gliomas: a protocol for a systematic review.
Gharooni, AA; Gillespie, CS; Gough, M; Jenkinson, MD; Patel, W; Plaha, P; Poon, MTC; Price, SJ; Solomou, G; Venkatesh, A; Watts, C; Wykes, V, 2022
)
1.44
"5-aminolevulinic acid (ALA) is a natural amino acid and a product of the first heme synthesis pathway in mitochondria. "( The effect of 5-aminolevulinic acid on canine peripheral blood mononuclear cells.
Igase, M; Iwatani, N; Mizukami, Y; Mizuno, T; Sakai, A; Watanabe, K, 2022
)
1.79
"5-Aminolevulinic acid (ALA) is a new natural plant growth regulator that inhibits abscisic acid (ABA)-induced stomatal closure. "( ALA Upregulates MdPTPA Expression to Increase the PP2A Activity and Promote Stomatal Opening in Apple Leaves.
Chen, Z; Wang, L, 2022
)
1.44
"5-Aminolevulinic acid (5-ALA) is an amino acid that can be metabolized into a photosensitizer, protoporphyrin IX (PpIX) selectively in a tumor cell, permitting minimally invasive photodynamic diagnosis/therapy. "( Polymeric iron chelators for enhancing 5-aminolevulinic acid-induced photodynamic therapy.
Guo, H; Honda, Y; Ishii, T; Ishizuka, M; Komoto, K; Nagano, T; Nishiyama, N; Nomoto, T; Ogura, SI, 2023
)
1.9
"5-Aminolevulinic acid (ALA) is a natural and environmentally benign multifunctional plant growth regulator involved in the regulation of plant tolerance to various environmental stresses. "( MeJA-mediated enhancement of salt-tolerance of Populus wutunensis by 5-aminolevulinic acid.
Jin, H; Li, B; Liu, H; Sun, J; Zou, J, 2023
)
1.86
"5-Aminolevulinic acid (5-ALA) is a crucial precursor of heme, which is essential for CII, complex III, complex IV (CIV) and cytochrome c activities."( 5-Aminolevulinic acid bypasses mitochondrial complex I deficiency and corrects physiological dysfunctions in Drosophila.
Ando, K; Asada, A; Ishii, T; Ishizuka, M; Noguchi, M; Nozawa, N; Saito, T; Shinno, K; Takahashi, K, 2023
)
2.19
"Five-aminolevulinic acid (5-ALA) is a natural product that induces heme oxygenase (HO)-1, which acts as an antioxidant."( Five-Aminolevulinic Acid (5-ALA) Induces Heme Oxygenase-1 and Ameliorates Palmitic Acid-Induced Endoplasmic Reticulum Stress in Renal Tubules.
Hamada, S; Hanada, H; Isomoto, H; Iyama, T; Kubo, M; Mae, Y; Sugihara, T; Takata, T; Taniguchi, S, 2023
)
1.88
"5-Aminolevulinic acid is a prodrug clinically approved for PDT."( Enhanced Delivery of 5-Aminolevulinic Acid by Lecithin Invasomes in 3D Melanoma Cancer Model.
Caputo, A; Filotico, R; Gaballo, A; Gallo, N; Guida, G; Nito, A; Nobile, C; Piccirillo, C; Quarta, A; Ragusa, A; Salvatore, L; Zito, A, 2023
)
1.78
"5-aminolevulinic acid (5-ALA) is a widely used photosensitizer."( Nanoparticles drug delivery for 5-aminolevulinic acid (5-ALA) in photodynamic therapy (PDT) for multiple cancer treatment: a critical review on biosynthesis, detection, and therapeutic applications.
Anjum, MM; Bhattacharya, S; Prajapati, BG; Singh, S, 2023
)
1.75
"5-aminolevulinic acid (ALA) is a compound that acts as a precursor in the biosynthesis of tetrapyrroles and can increase plant tolerance to different abiotic stressors."( Exogenously applied 5-aminolevulinic acid modulates growth, yield, and physiological parameters in lentil (Lens culinaris Medik.) under rain-fed and supplemental irrigation conditions.
Ezati, P; Ghorbanpour, M; Hazrati, S; Mohammadi, H, 2023
)
1.78
"5-aminolevulinic acid hydrochloride is a highly effective drug in reducing tumor residuals in transurethral resection of the bladder tumors; however, hypotension is a serious side effect that causes clinical problems. "( [Effectiveness of Pharmaceutical Intervention While Administering 5-Aminolevulinic Acid Hydrochloride through a Collaboration of Physicians and Pharmacists].
Aoyama, S; Kasahara, S; Komeda, H; Mizui, T; Tachi, T; Takai, A; Tanaka, K; Yasuda, M, 2023
)
1.87
"5-Aminolevulinic acid (5-ALA) is a delta amino acid naturally present in every living cell of the human body. "( Safety and Mode of Action of Diabetes Medications in comparison with 5-Aminolevulinic Acid (5-ALA).
Iftikhar, H; Jabbar, Z; Nakajima, M; Rehani, PR; Rehani, RN; Tanaka, T, 2019
)
1.47
"5-Aminolevulinic acid (5-ALA) is a porphyrin-based photosensitizer and has been used for photodynamic therapy of cervical intraepithelial neoplasia (CIN). "( Photodetection and Safety of 5-Aminolevulinic Acid-Induced Porphyrin in Patients With Cervical Intraepithelial Neoplasia.
Bai, W; Cao, F; Chen, R; Cui, Y; Dong, Y; Shi, Y; Tao, J; Xu, J; Zhao, J; Zhao, X, 2021
)
1.63
"5-aminolevulinic acid (5-ALA) is a constituent of mitochondrial electron carriers, heme and cytochrome c, which are crucial for aerobic energy metabolism and cell apoptosis. "( Inhibitory Effect of Orally Administered 5-Aminolevulinic Acid on Prostate Carcinogenesis in the FVB-Transgenic Adenocarcinoma of a Mouse Prostate (FVB-TRAMP) Model.
Anai, S; Fujimoto, K; Hori, S; Iemura, Y; Iida, K; Itami, Y; Miyake, M; Nakai, Y; Onishi, K; Onishi, S; Owari, T; Shimada, K; Tanaka, N; Tatsumi, Y, 2020
)
1.54
"5-Aminolevulinic acid (ALA) is an essential intermediate for many organisms and has been considered for the applications of medical especially in photodynamic therapy of cancer recently. "( Plasmid-Free System and Modular Design for Efficient 5-Aminolevulinic Acid Production by Engineered Escherichia coli.
Ng, IS; Shih, IT; Yi, YC, 2021
)
1.59
"5-Aminolevulinic acid (5-ALA) is a naturally occurring non-proteinogenic amino acid, which contributes to the diagnosis and therapeutic approaches of various cancers, including glioblastoma (GBM). "( Antitumor Effects of 5-Aminolevulinic Acid on Human Malignant Glioblastoma Cells.
Abbasinezhad-Moud, F; Etezad Razavi, M; Gorji, A; Jalili-Nik, M; Khaleghi Ghadiri, M; Maghrouni, A; Sahab-Negah, S; Stummer, W, 2021
)
1.65
"5-Aminolevulinic acid (5-ALA) is a prodrug used in photodynamic therapy (PDT) of tumors, including cancer of the oral mucosa. "( α-Bisabolol improves 5-aminolevulinic acid retention in buccal tissues: Potential application in the photodynamic therapy of oral cancer.
Campos de Oliveira Miguel, N; Dos Santos Miranda Costa, I; Freiman de Souza Ramos, M; Quintanilha, NP; Riemma Pierre, MB, 2017
)
1.49
"5-Aminolevulinic acid (ALA) is a precursor of the photosensitizing agent protoporphyrin IX (PpIX)."( Novel potential photodynamic therapy strategy using 5-Aminolevulinic acid for ovarian clear-cell carcinoma.
Ishii, T; Ishizuka, M; Kajiyama, H; Kikkawa, F; Kitajima, Y; Mizuno, M; Sakata, J; Shibata, K; Teshigawara, T; Utsumi, F, 2018
)
1.29
"5-aminolevulinic acid(5-ALA)is an endogenous natural amino acid and precursor of the heme pathway."( [A Useful Case of Photodynamic Diagnosis of Inferior Vena Cava Invasion by Pancreatic Head Cancer Using 5-Aminolevulinic Acid(5-ALA)].
Arita, T; Fujiwara, H; Ikoma, H; Konishi, H; Kosuga, T; Kuriu, Y; Mizutani, T; Morimura, R; Murayama, Y; Nakanishi, M; Okamoto, K; Otsuji, E; Shiozaki, A, 2018
)
1.25
"5-aminolevulinic acid (5-ALA) is a prodrug that results in the fluorescence of high-grade gliomas relative to the surrounding brain parenchyma. "( Fluorescence-guided surgery for high-grade gliomas.
Hadjipanayis, CG; Lakomkin, N, 2018
)
1.2
"5-Aminolevulinic acid (5-ALA) is a prodrug preferentially metabolized by glioma cells that allows direct, real-time visualization of pathologic tissue through fluorescence under blue light."( The impact of 5-aminolevulinic acid on extent of resection in newly diagnosed high grade gliomas: a systematic review and single institutional experience.
Haider, SA; Kalkanis, SN; Lee, IY; Lim, S, 2019
)
1.42
"Aminolevulinic acid (ALA) is a prodrug that is metabolized in the heme biosynthesis pathway to produce protoporphyrin IX (PpIX) for tumor fluorescence detection and photodynamic therapy (PDT). "( Ferrochelatase Deficiency Abrogated the Enhancement of Aminolevulinic Acid-mediated Protoporphyrin IX by Iron Chelator Deferoxamine.
Braun, A; Chen, B; Howley, R; Kraus, D; Mansi, M; Myers, KA; Palasuberniam, P, 2019
)
2.2
"5-Aminolevulinic acid (ALA) is a value-added compound with potential applications in the fields of agriculture and medicine. "( Enhancing 5-aminolevulinic acid tolerance and production by engineering the antioxidant defense system of Escherichia coli.
Chen, J; Chen, N; Guo, X; Ma, Y; Sun, J; Wang, L; Wang, Y; Zheng, P; Zhu, C, 2019
)
1.61
"5-Aminolevulinic acid (ALA) is an important cellular metabolic intermediate that has broad agricultural and medical applications. "( Multi-enzymatic recycling of ATP and NADPH for the synthesis of 5-aminolevulinic acid using a semipermeable reaction system.
Aiguo, Z; Meizhi, Z; Ruiwen, D, 2019
)
1.47
"Aminolevulinic acid (ALA) is a heme precursor that may have potential applications for photodynamic detection and photodynamic therapy-based treatment of solid tumors in a variety of malignancies. "( Aminolevulinic acid (ALA): photodynamic detection and potential therapeutic applications.
Apel, M; Brown, G; Jones, C; Lang, JE; Nokes, B, 2013
)
3.28
"5-aminolevulinic acid (ALA) is a precursor of haemoglobin which leads to the synthesis of porphyrins in malignant gliomas which then appears with red fluorescence under blue light. "( [Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant gliomas--a new treatment modality].
Cortnum, S; Laursen, R, 2013
)
1.39
"5-Aminolevulinic acid (5-ALA) is a precursor of the strong photosensitizer, protoporphyrin IX, in cancer cells. "( 5-Aminolevulinic acid-mediated photodynamic therapy using light-emitting diodes of different wavelengths in a mouse model of peritoneally disseminated gastric cancer.
Hino, H; Inoue, K; Murayama, Y; Nakajima, M; Nakanishi, M; Otsuji, E, 2013
)
1.83
"5-Aminolevulinic acid (ALA) is a precursor of heme. "( Antitumor effect of combination of hyperthermotherapy and 5-aminolevulinic acid (ALA).
Abe, F; Hasegawa, T; Ishii, T; Kishi, A; Nakajima, M; Sadamoto, K; Suzuki, A; Takahashi, K; Tanaka, T; Uno, K; Yasuda, I, 2013
)
1.35
"5-Aminolevulinic acid (ALA) is a prodrug for topical photodynamic therapy. "( In vitro evaluation of 5-aminolevulinic acid (ALA) loaded PLGA nanoparticles.
Huang, Z; Luan, H; Shi, L; Tu, Q; Wang, H; Wang, X; Zhao, F, 2013
)
1.41
"5-Aminolevulinic acid (ALA) is a natural heme precursor metabolized into protoporphyrin IX (PpIX). "( Synergistic apoptotic effect of Doxil ® and aminolevulinic acid-based photodynamic therapy on human breast adenocarcinoma cells.
El-Daly, SM; Gamal-Eldeen, AM; Saleh, S; Zakaria, S, 2014
)
1.38
"5-aminolevulinic acid (5-ALA) is an intermediate substrate of heme metabolism."( Fluorescent detection of peritoneal metastasis in human colorectal cancer using 5-aminolevulinic acid.
Fujiwara, H; Ichikawa, D; Ikoma, H; Inoue, K; Komatsu, S; Kondo, Y; Konishi, H; Kubota, T; Kuriu, Y; Morimura, R; Murayama, Y; Nakajima, M; Nakanishi, M; Okamoto, K; Otsuji, E; Sakakura, C; Shiozaki, A; Takahashi, K, 2014
)
1.19
"5-aminolevulinic acid is a natural precursor of the photosensitizer protoporphyrin IX."( Photodynamic therapy using systemic administration of 5-aminolevulinic acid and a 410-nm wavelength light-emitting diode for methicillin-resistant Staphylococcus aureus-infected ulcers in mice.
Awazu, K; Honda, N; Ito, N; Matsumoto, S; Morimoto, K; Ozawa, T; Tsuruta, D, 2014
)
1.21
"Five-aminolevulinic acid (ALA) is a prodrug to generate phototoxic protoporphyrin IX (PPIX) for photodynamic cancer therapy. "( Kinetic Evaluation of Determinant Factors for Cellular Accumulation of Protoporphyrin IX Induced by External 5-Aminolevulinic Acid for Photodynamic Cancer Therapy.
Nakanishi, T; Ogawa, T; Tamai, I; Yanagihara, C, 2015
)
1.14
"5-Aminolevulinic acid (5-ALA) is a precursor of a strong photosensitizer, protoporphyrin IX (PphIX), for photodynamic therapy (PDT). "( Targeted delivery of 5-aminolevulinic acid by multifunctional hollow mesoporous silica nanoparticles for photodynamic skin cancer therapy.
Ma, X; Qu, Q; Zhao, Y, 2015
)
1.45
"5-aminolevulinic acid (ALA) is a naturally occurring amino acid that is a protoporphyrin IX (PpIX) precursor and a next-generation photosensitive substance. "( Clinical applications of 5-aminolevulinic acid-mediated fluorescence for gastric cancer.
Hanazaki, K; Inoue, K; Namikawa, T; Shuin, T; Yatabe, T, 2015
)
1.44
"5-Aminolevulinic acid (ALA) is a naturally occurring amino acid present in diverse organisms and a precursor of heme biosynthesis. "( In vivo curative and protective potential of orally administered 5-aminolevulinic acid plus ferrous ion against malaria.
Balogun, EO; Hikosaka, K; Kita, K; Kobayashi, F; Komatsuya, K; Nakajima, M; Niikura, M; Suzuki, S; Takahashi, K; Tanaka, T, 2015
)
1.37
"5-Aminolevulinic acid (ALA) is a widely used photodynamic therapy (PDT) prodrug in the clinic. "( Immobilization of ALA-Zn(II) Coordination Polymer Pro-photosensitizers on Magnetite Colloidal Supraparticles for Target Photodynamic Therapy of Bladder Cancer.
Guo, J; Sun, C; Tan, J; Wang, C; Xu, K, 2015
)
1.14
"5-Aminolevulinic acid (ALA) is an L-glutamate derived non-protein amino acid, and is widely applied in fields such as medicine and agriculture."( Engineering Corynebacterium glutamicum to produce 5-aminolevulinic acid from glucose.
Jin, H; Liu, W; Qi, Q; Wang, Q; Yu, X, 2015
)
1.23
"5-Aminolevulinic acid (ALA) is a nonprotein amino acid that has been widely used in many fields. "( Integrated Optimization of the In Vivo Heme Biosynthesis Pathway and the In Vitro Iron Concentration for 5-Aminolevulinate Production.
Chen, J; Ding, W; Du, G; Kang, Z; Zhang, J, 2016
)
1.16
"5-Aminolevulinic acid (5-ALA) is a naturally occurring amino acid and precursor of heme and protoporphyrin IX (PpIX). "( 5-Aminolevulinic acid regulates the inflammatory response and alloimmune reaction.
Fujino, M; Ito, H; Li, XK; Nishio, Y; Tanaka, T, 2016
)
1.88
"5-aminolevulinic acid (5-ALA) is a natural precursor of protoporphyrin IX (PP IX), which possesses fluorescent properties and is more intensively accumulated in tumor cells than in normal tissue. "( Laser biospectroscopy and 5-ALA fluorescence navigation as a helpful tool in the meningioma resection.
Chumakova, AP; Golbin, DA; Goldberg, MF; Goryaynov, SA; Loschenov, VB; Okhlopkov, VA; Potapov, AA; Savelieva, TA; Shishkina, LV; Spallone, A; Varyukhina, MD, 2016
)
1.16
"5-aminolevulinic acid (5-ALA) is a drug currently used for PDT and is a hydrophilic molecule at its physiological pH, and this limits its capacity to cross the stratum corneum of skin."( A Formulation Study of 5-Aminolevulinic Encapsulated in DPPC Liposomes in Melanoma Treatment.
Chen, CL; Chou, CY; Huang, YB; Hung, SY; Lin, MW; Wu, PC, 2016
)
0.99
"5-Aminolevulinic acid (ALA) is a precursor of the photosensitizer protoporphyrin (PpIX) used in photodynamic therapy. "( Combined treatment with X-ray irradiation and 5-aminolevulinic acid elicits better transcriptomic response of cell cycle-related factors than X-ray irradiation alone.
Iwahashi, H; Misawa, M; Takahashi, J, 2016
)
1.41
"5-Aminolevulinic acid (ALA) is a FDA-approved photodynamic therapy (PDT) precursor of protoporphyrin IX (PpIX) used for treating various cancers. "( Zwitterionic stealth peptide-capped 5-aminolevulinic acid prodrug nanoparticles for targeted photodynamic therapy.
Ji, J; Jin, Q; Li, H; Lin, Y; Wu, J, 2017
)
1.45
"5-Aminolevulinic acid (5-ALA) is a precursor of a tetrapyrrole compound. "( Hair growth stimulatory effect by a combination of 5-aminolevulinic acid and iron ion.
Ishizuka, M; Ito, Y; Maeda, T; Morokuma, Y; Tanaka, T; Tsuboi, R; Yamazaki, M; Yoshino, I, 2008
)
1.32
"5-Aminolevulinic acid (ALA) is a prodrug used in photodynamic therapy, fluorescent diagnosis, and fluorescent-guided resection because it leads to accumulation of the photosensitizer protoporphyrin IX (PpIX) in tumor tissues. "( Transport of the photodynamic therapy agent 5-aminolevulinic acid by distinct H+-coupled nutrient carriers coexpressed in the small intestine.
Anderson, CM; Conlon, NJ; Edwards, N; Ganapathy, V; Jevons, M; Thangaraju, M; Thwaites, DT; Woods, S, 2010
)
1.34
"5-Aminolevulinic acid (5-ALA) is a natural precursor of protoporphyrin IX (PpIX), which can be used as a photosensitizer in photodynamic therapy (PDT). "( Susceptibility to 5-aminolevulinic acid based photodynamic therapy in WHO I meningioma cells corresponds to ferrochelatase activity.
Albert, I; Hefti, M; Holenstein, F; Looser, H; Luginbuehl, V,
)
1.18
"5-Aminolevulinic acid (ALA) is a natural, delta amino acid biosynthesized by animal and plant mitochondria."( Novel development of 5-aminolevurinic acid (ALA) in cancer diagnoses and therapy.
Abe, F; Inoue, K; Ishizuka, M; Kohda, T; Komatsu, N; Nakajima, M; Ogura, S; Sano, Y; Takahashi, K; Tanaka, T, 2011
)
0.93
"5-Aminolevulinic acid (ALA) is a prodrug used in photodynamic therapy and fluorescence-guided resection of malignant gliomas due to its high cellular uptake in tumours. "( Radiosensitizing effect of 5-aminolevulinic acid-induced protoporphyrin IX in glioma cells in vitro.
Akiba, D; Kitagawa, T; Nakano, Y; Nishizawa, S; Ogura, S; Saito, T; Takahashi, M; Tanaka, T; Yamamoto, J, 2012
)
1.39
"5-Aminolevulinic acid (ALA) is an intermediate in the biosynthesis of tetrapyrroles. "( High level production of 5-aminolevulinic acid by Propionibacterium acidipropionici grown in a low-cost medium.
Jongsareejit, B; Sonhom, R; Thepsithar, C, 2012
)
1.4
"5-Aminolevulinic acid (ALA) is an important plant growth regulator which is derived from 5-carbon aliphatic amino acid. "( 5-aminolevulinic acid alleviates the salinity-induced changes in Brassica napus as revealed by the ultrastructural study of chloroplast.
Ahmad, R; Liu, D; Liu, H; Naeem, MS; Waraich, EA; Warusawitharana, H; Xu, L; Zhou, W, 2012
)
1.82
"5-aminolevulinic acid (5-ALA) is a pro-drug that leads to accumulation of fluorescent protoporphyrins in malignant gliomas."( Fluorescence-guided resection of gliomas.
Cortnum, S; Laursen, RJ, 2012
)
0.94
"5-Aminolevulinic acid (ALA) is a precursor to heme synthesis pathway and currently used to induce endogenous protoporphyrin IX (PpIX, a potent photosensitizer) for photodynamic therapy of cancer. "( Comparison of 5-aminolevulinic acid and its hexylester mediated photodynamic action on human hepatoma cells.
Chen, JY; Peng, Q; Ren, QG; Wu, SM, 2002
)
1.38
"5-Aminolevulinic acid (ALA) is a heme precursor that accumulates in some porphyric disorders and in lead poisoning which can undergo metal-catalyzed oxidation producing reactive oxygen species and the keto-aldehyde, 4,5-dioxovaleric acid (DOVA). "( Genotoxicity of 5-aminolevulinic and 4,5-dioxovaleric acids in the salmonella/microsuspension mutagenicity assay and SOS chromotest.
de A Umbuzeiro, G; Di Mascio, P; Medeiros, MH; Onuki, J; Rech, CM, 2002
)
1.04
"Aminolevulinic acid (ALA) acts as a prodrug leading to a selective accumulation of a photosensitizer, protoporphyrin IX (PpIX), in epithelial cells."( Interstitial photodynamic therapy in subcutaneously implanted urologic tumors in rats after intravenous administration of 5-aminolevulinic acid.
Brown, K; Moore, R; Tamimi, Y; Tulip, J; Xiao, Z,
)
1.06
"Aminolevulinic acid is a prodrug that is metabolized intracellularly to form the photosensitizing molecule protoporphyrin IX (PpIX)."( Photodynamic therapy and topical aminolevulinic acid: an overview.
Gupta, AK; Ryder, JE, 2003
)
1.32
"Aminolevulinic acid (ALA) is a charged, hydrophilic molecule that penetrates poorly through cellular structures. "( Evaluation of the penetration of 5-aminolevulinic acid through basal cell carcinoma: a pilot study.
Ahmadi, S; Donnelly, RF; McCarron, PA; McKenna, K; Woolfson, AD, 2004
)
2.04
"5-aminolevulinic acid (5-ALA) is a precursor in synthesis of endogenous porphyrins used to sensitize tumor tissues in photodynamic therapy (PDT). "( Enhancement of photodynamic therapy by use of aminolevulinic acid/glycolic acid drug mixture.
Bronowicz, A; Oremek, G; Osiecka, BJ; Saleh, Y; Siewinski, M; Symonowicz, K; Ziolkowski, P, 2004
)
1.3
"5-Aminolevulinic acid (ALA) is a heme precursor accumulated in plasma and in organs in acute intermittent porphyria (AIP), a disease associated with neuromuscular dysfunction and increased incidence of hepatocellular carcinoma (HCC). "( Mitochondrial and nuclear DNA damage induced by 5-aminolevulinic acid.
Chen, Y; Di Mascio, P; Medeiros, MH; Onuki, J; Schumacher, RI; Teixeira, PC; Van Houten, B, 2004
)
1.3
"5-Aminolevulinic acid (5-ALA) is a useful agent to enhance the detection of early epithelial lesions in head and neck cancers. "( Excretion measurement of porphyrins and their precursors after topical administration of 5-aminolaevulinic acid for fluorescence endoscopy in head and neck cancer.
Brossmann, P; Doss, MO; Gross, U; Klahr, N; Klein, M; Külkens, C; Lippert, BM; Ney, M; Teymoortash, A; Werner, JA, 2003
)
1.04
"5-Aminolevulinic acid (5-ALA) is a pro-drug which can be converted to the effective photosensitizer, protoporphyrin IX (PpIX)."( Topical glycerol monooleate/propylene glycol formulations enhance 5-aminolevulinic acid in vitro skin delivery and in vivo protophorphyrin IX accumulation in hairless mouse skin.
Bentley, MV; Collett, J; De Rosa, FS; Steluti, R; Tedesco, AC, 2005
)
1.12
"5-aminolevulinic acid (ALA) is an endogenous precursor for several photosensitizing porphyrins formed by heme biosynthesis, and has been studied for PDT with promising results for some superficial diseases of the skin and hollow internal organs."( New derivatives of 5-aminolevulinic acid for photodynamic therapy: chemical synthesis and porphyrin production in in vitro and in vivo biological systems.
Branden, JE; Godal, A; Klaveness, J; Nesland, JM; Nilsen, NO; Peng, Q, 2006
)
1.21
"5-Aminolevulinic acid (5-ALA) is a well characterized precursor in the synthesis of various endogenous porphyrins used in photodynamic therapy (PDT). "( Pretreatment of plantar warts with azone enhances the effect of 5-aminolevulinic acid photodynamic therapy.
Bronowicz, A; Gerber-Leszczyszyn, H; Osiecka, BJ; Siewinski, M; Ziolkowska, J; Ziolkowski, P, 2006
)
1.29
"5-Aminolevulinic acid is a non-fluorescent prodrug that leads to intracellular accumulation of fluorescent porphyrins in malignant gliomas-a finding that is under investigation for intraoperative identification and resection of these tumours. "( Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial.
Meinel, T; Pichlmeier, U; Reulen, HJ; Stummer, W; Wiestler, OD; Zanella, F, 2006
)
1.33
"5-Aminolevulinic acid (ALA) is a natural precursor of protoporphyrin IX (PpIX) and heme in cells. "( Biological activity of 5-aminolevulinic acid and its methyl ester after storage under different conditions.
Graczyk, A; Iani, V; Juzenas, P; Juzeniene, A; Kaliszewski, M; Kwasny, M; Ma, LW; Mikolajewska, P; Moan, J, 2007
)
1.36
"Five-aminolevulinic acid (ALA) is a drug which induces protoporphyrin IX accumulation in malignant gliomas and has been explored for fluorescence-guided resections of these tumors."( Long-sustaining response in a patient with non-resectable, distant recurrence of glioblastoma multiforme treated by interstitial photodynamic therapy using 5-ALA: case report.
Baumgartner, R; Beck, T; Beyer, W; Etminan, N; Herms, J; Kreth, FW; Mehrkens, JH; Obermeier, A; Stepp, H; Stummer, W; Tonn, JC, 2008
)
0.8
"5-Aminolevulinic acid (ALA) is a precursor of heme biosynthesis. "( Biodistribution and phototoxicity of 5-aminolevulinic acid-induced PpIX in an orthotopic rat bladder tumor model.
Bachor, R; Flotte, T; Hasan, T; Iinuma, S, 1995
)
1.28
"5-Aminolevulinic acid (5-ALA) is a precursor in the biosynthesis of haem. "( Photodynamic therapy of experimental colonic tumours with 5-aminolevulinic-acid-induced endogenous porphyrins.
Genze, F; König, K; Orth, K; Rück, A, 1994
)
1.01
"Aminolevulinic acid (ALA) is a precursor of protoporphyrin IX (PP IX), a potent photosensitizer."( Aminolevulinic acid for photodynamic therapy of bladder carcinoma cells.
Bachor, R; Hautmann, R; Reich, E; Rück, A, 1996
)
2.46
"5-Aminolevulinic acid is shown to be a promising anticancer preparation."( [Tetrapyrroles: diversity, biosynthesis, biotechnology].
Bykhovskiĭ, VIa; Eliseev, AA; Zaĭtseva, NI,
)
0.69
"5-aminolevulinic acid is an early intermediate product in the synthesis of heme. "( [Use of 5-aminolevulinic acid in photochemotherapy and fluorescence diagnostics].
Bech, O; Berg, K; Moan, J; Peng, Q, 1998
)
1.42
"5-Aminolevulinic acid (ALA) is a heme precursor, pathological accumulation of which is associated with liver cancer. "( Hydroxyl radicals are involved in the oxidation of isolated and cellular DNA bases by 5-aminolevulinic acid.
Bechara, EJ; Cadet, J; Di Mascio, P; Douki, T; Medeiros, MH; Onuki, J, 1998
)
1.24
"5-Aminolevulinic acid (ALA) is an attractive photosensitizing agent for photodynamic therapy (PDT) as its photoactive derivative, protoporphyrin IX, is metabolized within 1-2 days, eliminating prolonged skin photosensitivity. "( Light dose fractionation to enhance photodynamic therapy using 5-aminolevulinic acid in the normal rat colon.
Bown, SG; Curnow, A; MacRobert, AJ; McIlroy, BW; Postle-Hacon, MJ, 1999
)
1.26
"5-Aminolevulinic acid (ALA) is a heme precursor that accumulates in acute intermittent porphyria and lead poisoning. "( N-acetyl-L-cysteine protects against delta-aminolevulinic acid-induced 8-hydroxydeoxyguanosine formation.
Ercal, N; Yildiz, D; Yusof, M, 1999
)
1.29
"5-Aminolevulinic acid (5-ALA) is a precursor of porphyrins and heme that has been implicated in the neuropsychiatric symptoms associated with porphyrias. "( Mechanisms of 5-aminolevulinic acid uptake at the choroid plexus.
Keep, RF; Novotny, A; Smith, DE; Stummer, W; Teuscher, NS; Xiang, J, 2000
)
1.37
"5-Aminolevulinic acid (ALA) is a heme precursor that accumulates in lead poisoning and inborn porphyrias. "( DNA damage by 3,6-dihydropyrazine-2,5-dipropanoic acid, the cyclic dimerization product of 5-aminolevulinic acid.
Di Mascio, P; Dörnemann, D; Medeiros, MH; Onuki, J; Teixeira, PC, 2001
)
1.25
"5-Aminolevulinic acid (ALA) is a heme precursor that accumulates in acute intermittent porphyria (AIP) due to enzymatic deficiencies in the heme biosynthetic pathway Its accumulation has been associated with several symptoms, such as abdominal pain attacks, neuromuscular weaknesses, neuropsychiatric alterations and increased hepatocellular carcinoma (HCC) incidence. "( Is 5-aminolevulinic acid involved in the hepatocellular carcinogenesis of acute intermittent porphyria?
Cadet, J; Di Mascio, P; Dörnemann, D; Douki, T; Medeiros, MH; Onuki, J; Teixeira, PC, 2002
)
1.55
"5-Aminolevulinic acid (ALA) is a precursor of protoporphyrin IX (PpIX) that is being evaluated for use in photodiagnosis and phototherapy of malignant and nonmalignant disorders. "( Clinical pharmacokinetics of 5-aminolevulinic acid in healthy volunteers and patients at high risk for recurrent bladder cancer.
Dalton, JT; Golub, AL; Marcus, SL; Meyer, MC; Straughn, A; Yates, CR; Yin, D, 2002
)
1.32
"5-Aminolevulinic acid (ALA) is an endogenous substance which is converted to protoporphyrin IX (PpIX) in the synthetic pathway to heme."( Effects of photodynamic therapy with topical application of 5-aminolevulinic acid on normal skin of hairless guinea pigs.
Bachor, R; Goff, BA; Hasan, T; Kollias, N, 1992
)
1.08
"5-Aminolevulinic acid (ALA) is a natural compound in the heme biosynthesis pathway."( Flow Cytometry-Based Photodynamic Diagnosis with 5-Aminolevulinic Acid for the Detection of Minimal Residual Disease in Multiple Myeloma.
Fujimaki, S; Fujiwara, M; Fujiwara, T; Fukuhara, N; Harigae, H; Ito, T; Iwaki, K; Onishi, Y; Ono, K; Saito, K; Sasaki, K; Suzuki, C; Tamura, H; Tanaka, T; Yokoyama, H, 2019
)
1.32
"5-Aminolevulinic acid is a precursor of photosensitizing protoporphyrin IX and has been applied for photodynamic diagnosis of brain and bladder tumors with few side effects. "( Expression of coproporphyrinogen oxidase is associated with detection of upper gastrointestinal carcinomas by 5-aminolevulinic acid-mediated photodynamic diagnosis.
Akazawa, Y; Fukuoka, J; Hashisako, M; Hidaka, S; Ishii, H; Isomoto, H; Kanda, T; Kunizaki, M; Kurumi, H; Matsushima, K; Nagayasu, T; Nakao, K; Nanashima, A; Ogihara, K; Ohnita, K; Tabata, K; Takeshima, F; Yamaguchi, N, 2017
)
1.39
"5-Aminolevulinic acid (5-ALA) is a key metabolic intermediate of the heme biosynthesis pathway, which has broad application prospects in agriculture and medicine. "( Stable and Efficient Biosynthesis of 5-Aminolevulinic Acid Using Plasmid-Free Escherichia coli.
Cui, Z; Gong, K; Jiang, X; Jiang, Z; Liang, Q; Qi, Q; Wang, Q; Zhang, J; Zheng, H, 2019
)
1.5
"5-Aminolevulinic acid is a precursor of a photosensitizing substance with affinity for tumors; thus, diagnostic laparoscopy using ALA-PDD in combination should improve the accuracy of detecting peritoneal dissemination in patients with advanced gastric cancer."( Evolution of photodynamic medicine based on fluorescence image-guided diagnosis using indocyanine green and 5-aminolevulinic acid.
Hanazaki, K; Inoue, K; Iwabu, J; Kitagawa, H; Kobayashi, M; Maeda, H; Munekage, M; Nakayama, T; Namikawa, T; Sato, T; Uemura, S, 2020
)
1.33

Effects

5-aminolevulinic acid (5-ALA) has been used for the last 5 years to increase the extent of resection in adult brain tumors, mostly glioblastomas. It is not approved yet as standard adjuvant treatment in the pediatric population.

ExcerptReferenceRelevance
"5-aminolevulinic acid (5-ALA) has a poor penetrance of the skin with topical application, which reduces the efficacy of photodynamic therapy (PDT). "( Sonophoresis enhances the skin penetration of 5-aminolevulinic acid: A promising pretreatment for photodynamic therapy.
Fan, W; Jiang, L; Lu, Y; Zheng, Y, 2022
)
1.7
"Aminolevulinic acid (ALA) has been clinically used as an intraoperative fluorescence probe for protoporphyrin IX (PpIX) fluorescence-guided tumor resection and a PDT agent for cancer treatment. "( Methods to Measure the Inhibition of ABCG2 Transporter and Ferrochelatase Activity to Enhance Aminolevulinic Acid-Protoporphyrin IX Fluorescence-Guided Tumor Detection and Resection.
Chen, B; Howley, R; Mansi, M, 2022
)
2.38
"5-aminolevulinic acid (5-ALA) has a poor penetrance of the skin with topical application, which reduces the efficacy of photodynamic therapy (PDT). "( Sonophoresis enhances the skin penetration of 5-aminolevulinic acid: A promising pretreatment for photodynamic therapy.
Fan, W; Jiang, L; Lu, Y; Zheng, Y, 2022
)
1.7
"5-aminolevulinic acid (5-ALA) has demonstrated its utility as an intraoperative imaging adjunct during fluorescence guided resection of malignant gliomas. "( Utility of 5-ALA for fluorescence-guided resection of brain metastases: a systematic review.
Ben-Shalom, N; D'Amico, RS; Khilji, H; Leskinen, S; Narayan, V; Shah, HA, 2022
)
1.44
"5-Aminolevulinic acid (ALA) has been approved by the U. "( Targeting ABCG2 transporter to enhance 5-aminolevulinic acid for tumor visualization and photodynamic therapy.
Chandratre, S; Chen, B; Howley, R; Olsen, J, 2023
)
1.9
"5-aminolevulinic acid (5-ALA) has been increasingly used in recent years to identify anaplastic foci in primarily suspected low-grade gliomas (LGGs). "( Influence of Corticosteroids and Antiepileptic Drugs on Visible 5-Aminolevulinic Acid Fluorescence in a Series of Initially Suspected Low-Grade Gliomas Including World Health Organization Grade II, III, and IV Gliomas.
Berger, MS; Borkovec, M; Furtner, J; Hervey-Jumper, S; Hosmann, A; Kiesel, B; Mercea, PA; Mischkulnig, M; Rössler, K; Rötzer, T; Wadiura, LI; Widhalm, G, 2020
)
1.52
"5-aminolevulinic acid (5-ALA) has been utilized for cancer diagnosis as a fluorescence probe. "( 5-ALA-assistant automated detection of lymph node metastasis in gastric cancer patients.
Harada, Y; Koshiishi, N; Matsumoto, T; Matsuo, H; Murayama, Y; Okochi, K; Otsuji, E; Takamatsu, T; Tanaka, H, 2020
)
1.28
"5-Aminolevulinic acid (ALA) has been widely used as an intravital fluorescence marker in the fluorescence-guided resection of malignant gliomas. "( 5-Aminolevulinic Acid: Pitfalls of Fluorescence-guided Resection for Malignant Gliomas and Application for Malignant Glioma Therapy.
Kitagawa, T; Miyaoka, R; Nakano, Y; Saito, T; Suzuki, K; Takamatsu, S; Yamamoto, J, 2020
)
2
"Aminolevulinic acid (ALA) has been approved as an intraoperative molecular imaging probe for protoporphyrin IX (PpIX) fluorescence-guided resection of glioma. "( Evaluation of aminolevulinic acid-mediated protoporphyrin IX fluorescence and enhancement by ABCG2 inhibitors in renal cell carcinoma cells.
Chen, B; Howley, R; Mansi, M; Restrepo, J; Shinde, J, 2020
)
2.36
"5-Aminolevulinic acid (5-ALA) has been used as a sonodynamic sensitizer for cancer treatment."( Artesunate Enhances the Cytotoxicity of 5-Aminolevulinic Acid-Based Sonodynamic Therapy against Mouse Mammary Tumor Cells In Vitro.
Azuma, K; Imagawa, T; Ishizuka, M; Itoh, N; Kurahashi, T; Murahata, Y; Okamoto, Y; Osaki, T; Tanaka, T; Tsuka, T; Uto, Y; Yamanaka, N, 2017
)
1.28
"5-Aminolevulinic acid (5-ALA) has become an important assistant in glioblastoma (GB) surgery. "( Comparison of commercial 5-aminolevulinic acid (Gliolan®) and the pharmacy-compounded solution fluorescence in glioblastoma.
Bestard Escalas, J; Brell Doval, M; Delgado Sánchez, O; Garfias Arjona, S; Ibáñez Domínguez, JÁ; Lara Almunia, M; Maimó Barceló, A; Pierola Lopetegui, J; Villalonga, P; Villalonga-Planells, R, 2019
)
1.53
"5-aminolevulinic acid (5-ALA) has recently been employed for photodynamic diagnosis (ALA-PDD) and photodynamic therapy (ALA-PDT) of various types of cancer because hyperproliferating tumor cells do not utilize oxidative phosphorylation and do not efficiently produce heme; instead, they accumulate protoporphyrin IX (PpIX), which is a precursor of heme that is activated by violet light irradiation that results in the production of red fluorescence and singlet oxygen. "( Mechanistic study of PpIX accumulation using the JFCR39 cell panel revealed a role for dynamin 2-mediated exocytosis.
Dan, S; Ishii, T; Ishizuka, M; Kitajima, Y; Kohda, T; Nakajima, M; Nishimura, Y; Tanaka, T; Yamazaki, K, 2019
)
1.24
"Five-aminolevulinic acid (ALA) has received much attention recently as a new-generation photosensitive substance for photodynamic diagnosis (PDD). "( Photodynamic diagnosis using 5-aminolevulinic acid during gastrectomy for gastric cancer.
Fukuhara, H; Hanazaki, K; Inoue, K; Kitagawa, H; Kobayashi, M; Maeda, H; Namikawa, T; Shiga, M; Shuin, T; Uemura, S, 2014
)
1.2
"5-aminolevulinic acid (5-ALA) has been used for the last 5 years to increase the extent of resection in adult brain tumors, mostly glioblastomas, but it is not approved yet as standard adjuvant treatment in the pediatric population. "( 5-ALA fluorescence-assisted surgery in pediatric brain tumors: report of three cases and review of the literature.
Albanese, V; Barbagallo, GM; Certo, F; Heiss, K, 2014
)
1.12
"5-Aminolevulinic acid (5-ALA) has been suggested for improving plant salt tolerance via exogenous application. "( Study on salt tolerance with YHem1 transgenic canola (Brassica napus).
Feng, XX; Li, C; Sun, XE; Wang, LJ; Zhang, ZP, 2015
)
1.14
"5-aminolevulinic acid (5-ALA) has been established as an intraoperative tool in malignant glioma surgery."( The current status of 5-ALA fluorescence-guided resection of intracranial meningiomas-a critical review.
Crane, LM; Groen, RJ; Jeltema, HR; Metzemaekers, JD; Motekallemi, A; van Dam, GM, 2015
)
0.98
"5-Aminolevulinic acid (5-ALA) has been widely used in photodynamic therapy and immunofluorescence of tumours. "( The proton-coupled oligopeptide transporter 1 plays a major role in the intestinal permeability and absorption of 5-aminolevulinic acid.
Hu, Y; Smith, DE; Xie, Y, 2016
)
1.37
"5-Aminolevulinic acid (5-ALA) has recently attracted attention for its potential applications in the fields of medicine and agriculture. "( Metabolic engineering of Corynebacterium glutamicum for efficient production of 5-aminolevulinic acid.
Chen, T; Feng, L; Fu, J; Mao, Y; Wang, Z; Zhang, Y; Zhao, X, 2016
)
1.38
"5-Aminolevulinic acid (5-ALA) has become an integral part in the neurosurgical treatment of malignant glioma. "( 5-Aminolevulinic Acid Accumulation in a Cerebral Infarction Mimicking High-Grade Glioma.
Behling, F; Bornemann, A; Hennersdorf, F; Skardelly, M; Tatagiba, M, 2016
)
1.88
"5-Aminolevulinic acid (5-ALA) has been approved as an intraoperative adjunct in glioma surgery in Europe, but not North America. "( The role of 5-aminolevulinic acid in enhancing surgery for high-grade glioma, its current boundaries, and future perspectives: A systematic review.
Bernstein, M; Hachem, LD; Klironomos, G; Mansouri, A; Mansouri, S; Vogelbaum, MA; Zadeh, G, 2016
)
1.52
"5-Aminolevulinic acid (5-ALA) has been at the forefront of small molecule based fluorescence-guided tumor resection and photodynamic therapy. "( Tunable phosphatase-sensitive stable prodrugs of 5-aminolevulinic acid for tumor fluorescence photodetection.
Allémann, E; Ateb, I; Babič, A; Herceg, V; Lange, N, 2016
)
1.41
"5-Aminolevulinic acid has been used successfully to facilitate resection of adult malignant gliomas. "( Use of 5-aminolevulinic acid for visualization and resection of a benign pediatric brain tumor.
Liu, J; Ruge, JR, 2009
)
1.49
"5-aminolevulinic acid (5-ALA) has gained importance as an intraoperative photodynamic diagnostic agent for the extirpation of malignant gliomas. "( Intraoperative 5-aminolevulinic-acid-induced fluorescence in meningiomas.
Coluccia, D; Cordovi, S; Fandino, J; Fujioka, M; Landolt, H; Muroi, C, 2010
)
1.08
"5-Aminolevulinic acid (ALA) has been used as a photodynamic sensitizer for cancer treatment using photodynamic therapy. "( Apoptosis of SAS cells induced by sonodynamic therapy using 5-aminolevulinic acid sonosensitizer.
Cao, W; Cui, H; Song, W; Zhang, R; Zheng, J, 2011
)
1.33
"5-Aminolevulinic acid (ALA) has been successfully used to confirm the target tumor tissues obtained during stereotactic biopsy. "( Use of 5-aminolevulinic acid for the confirmation of deep-seated brain tumors during stereotactic biopsy. Report of 2 cases.
Dehara, M; Imakita, M; Moriuchi, S; Soda, T; Taneda, M; Teramoto, Y; Yamada, K, 2011
)
1.51
"5-Aminolevulinic acid (5-ALA) has already been applied clinically as a photosensitizer. "( Sonodynamic therapy with 5-aminolevulinic acid and focused ultrasound for deep-seated intracranial glioma in rat.
Fukushima, T; Inoue, T; Kuroki, M; Ohmura, T; Sasaki, K; Shibaguchi, H; Umemura, S; Yoshizawa, S, 2011
)
1.39
"5-Aminolevulinic acid (ALA) has recently attracted significant attentions due to its potential applications in many diverse fields. "( Metabolic engineering to improve 5-aminolevulinic acid production.
Kang, Z; Qi, Q; Wang, Q; Wang, Y,
)
1.13
"Five-aminolevulinic acid (5-ALA) has been shown to accumulate in malignant tumor tissue."( Strong 5-aminolevulinic acid-induced fluorescence is a novel intraoperative marker for representative tissue samples in stereotactic brain tumor biopsies.
Di Ieva, A; Furtner, J; Hainfellner, JA; Kiesel, B; Knosp, E; Marosi, C; Mert, A; Minchev, G; Prayer, D; Preusser, M; Tomanek, B; Widhalm, G; Woehrer, A; Wolfsberger, S, 2012
)
1.25
"5-Aminolevulinic acid (ALA) has shown promising in photodynamic detection and therapy of brain tumor. "( Protoporphyrin IX production and its photodynamic effects on glioma cells, neuroblastoma cells and normal cerebellar granule cells in vitro with 5-aminolevulinic acid and its hexylester.
Chen, JY; Peng, Q; Ren, QG; Wu, SM; Zhou, MO, 2003
)
1.24
"Aminolevulinic acid (ALA) has been shown to be the drug with most experimental and clinical use in the past."( Fluorescence diagnosis and photodynamic therapy in dermatology from experimental state to clinic standard methods.
Fritsch, C; Ruzicka, T, 2006
)
1.06
"Aminolevulinic acid (ALA) has demonstrated highest efficacy in topical PDT, and has become the most clinically useful."( Aminolevulinic acid (Levulan) in photodynamic therapy of actinic keratoses.
Fritsch, C; Lang, K; Ruzicka, T; Schulte, KW, 2001
)
2.47

Actions

ExcerptReferenceRelevance
"5-aminolevulinic acid (5-ALA) plays an important role in the fields of medicine and agriculture. "( [Engineering the C4 pathway of Corynebacterium glutamicum for efficient production of 5-aminolevulinic acid].
Li, H; Rao, Z; Shao, M; Wang, L; Xu, M; Yan, S; Yang, T; Zhang, X, 2021
)
1.56

Treatment

5-Aminolevulinic acid /PDT-treated GB spheroids attracted DCs that acquired tumour antigens. Pretreatment with protoporphyrin IX dramatically increased the light sensitivity of both TRPA1 and TRPV1 via generation of reactive oxygen species.

ExcerptReferenceRelevance
"Aminolevulinic acid-PDT spot treatment using a 3-hour occluded incubation was superior to VEH-PDT for AK lesion clearance of the upper extremity."( A Randomized, Vehicle-Controlled Phase 3 Study of Aminolevulinic Acid Photodynamic Therapy for the Treatment of Actinic Keratoses on the Upper Extremities.
Brian Jiang, SI; Houlihan, A; Kempers, S; Marcus, S; Pariser, D; Piacquadio, D; Rich, P, 2019
)
2.21
"5-Aminolevulinic acid /PDT-treated GB spheroids attracted DCs that acquired tumour antigens from the spheroids effectively. "( Heat-shock protein 70-dependent dendritic cell activation by 5-aminolevulinic acid-mediated photodynamic treatment of human glioblastoma spheroids in vitro.
Börger, V; Bünemann, E; Etminan, N; Hänggi, D; Lakbir, D; Peters, C; Sabel, MC; Sorg, RV; Steiger, HJ; Stummer, W, 2011
)
1.33
"Pretreatment with aminolevulinic acid or with protoporphyrin IX dramatically increased the light sensitivity of both TRPA1 and TRPV1 via generation of reactive oxygen species."( Photosensitization in Porphyrias and Photodynamic Therapy Involves TRPA1 and TRPV1.
Babes, A; Filipovic, M; Fischer, MJ; Kichko, TI; Moparthi, L; Namer, B; Neacsu, C; Reeh, PW; Sauer, SK; Zygmunt, PM, 2016
)
0.76

Toxicity

5-aminolevulinic acid (ALA)-PDT is an effective and safe treatment for vaginal HSIL with minimal side effects. However, the porphyrin precursor delta-aminolesilic acid (delta-ALA) is not toxic up to millimolar concentrations within a 30-h time period.

ExcerptReferenceRelevance
" The significance of these findings reveals itself in two ways: namely, that toxicologic investigations of lead and cadmium, whether experimental or clinical, must be based on a definitive consideration of the nutritional status of animals or people, and, secondly, that the preventive role of nutrition, especially that of trace metal intakes, must be taken seriously when establishing measures for reducing, eliminating, or combatting the toxic effects of widespread exposure to lead and cadmium in humans."( Some observations on the interaction of zinc, copper, and iron metabolism in lead and cadmium toxicity.
Petering, HG, 1978
)
0.26
" Only ALA (10 microM) and glutamic acid (1 mM) were toxic towards neurons in culture, as measured by cell survival after 5 days' exposure."( [Mechanism of delta-aminolevulinic acid neurotoxicity].
Lamm, MC; McCarthy, BW; Neethling, AC; Percy, VA; Taljaard, JJ; Truter, L, 1981
)
0.59
"Exposure to toxic chemicals may result in alterations of red cell function."( Chemical toxicity of red cells.
Piomelli, S, 1981
)
0.26
" However, the porphyrin precursor delta-aminolevulinic acid (delta-ALA) is not toxic up to millimolar concentrations within a 30-h time period."( Some aspects of porphyrin neurotoxicity in vitro.
Kennedy, JC; Riopelle, RJ, 1982
)
0.53
" However, results obtained with dispersed cells in culture may not necessarily reflect the situation in vivo where the cell may have a far greater resistance to the effects of toxic agents."( delta-Aminolaevulinic acid uptake, toxicity, and effect on [14C]gamma-aminobutyric acid uptake into neurons and glia in culture.
Lamm, MC; Percy, VA; Taljaard, JJ, 1981
)
0.26
" Lead from CDARB sediment accumulated more readily in duckling blood and liver than reported in goslings, but at given concentrations was generally less toxic to ducklings."( Developmental toxicity of lead-contaminated sediment to mallard ducklings.
Audet, DJ; Campbell, JK; Heinz, GH; Hoffman, DJ; LeCaptain, LJ; Sileo, L, 2000
)
0.31
" This study demonstrates that ALA-induced PDT provides safe and effective ablation therapy for Barrett's esophagus and is particularly useful against dysplasia."( Aminolevulinic acid-induced photodynamic therapy: safe and effective ablation of dysplasia in Barrett's esophagus.
Ackroyd, R; Brown, NJ; Davis, MF; Reed, MW; Stephenson, TJ; Stoddard, CJ, 2000
)
1.75
" We compared experimentally the photodynamic effect (light-toxic) and the side effect (dark-toxic) of the clinically attractive photosensitizers 5-aminolevulinic acid (ALA) and protoporphyrin IX (PP IX)."( Light irradiation increases embryotoxicity of photodynamic therapy sensitizers (5-aminolevulinic acid and protoporphyrin IX) in chick embryos.
Klepácek, I; Peterka, M,
)
0.56
"In order to expand our knowledge of zinc toxicity and to assess further the toxicities of zinc systematically, we observed the toxic effects of zinc on the functions of various tissues and organs in rats."( Subacute toxic effects of zinc on various tissues and organs of rats.
Ma, N; Piao, F; Yamauchi, T; Yokoyama, K, 2003
)
0.32
"No serious adverse events were observed."( Safety, pharmacokinetics and pharmocodynamics of recombinant human porphobilinogen deaminase in healthy subjects and asymptomatic carriers of the acute intermittent porphyria gene who have increased porphyrin precursor excretion.
Andersson, DE; Harper, P; Rejkjaer, L; Sardh, E, 2007
)
0.34
"The recombinant human porphobilinogen deaminase enzyme preparation was found to be safe to administer and effective for removal of the accumulated metabolite porphobilinogen from plasma and urine."( Safety, pharmacokinetics and pharmocodynamics of recombinant human porphobilinogen deaminase in healthy subjects and asymptomatic carriers of the acute intermittent porphyria gene who have increased porphyrin precursor excretion.
Andersson, DE; Harper, P; Rejkjaer, L; Sardh, E, 2007
)
0.34
" This method of enhancement was safely applied to a clinical PDT protocol with no unexpected adverse effects reported."( Enhancement of methyl-aminolevulinate photodynamic therapy by iron chelation with CP94: an in vitro investigation and clinical dose-escalating safety study for the treatment of nodular basal cell carcinoma.
Campbell, S; Curnow, A; Pye, A, 2008
)
0.35
" Further characterization of the transport system for uroporphyrin in this model is expected to benefit not only our understanding of the cellular mechanism for disposal of toxic soluble wastes but also potentially the effective management of human uroporphyria and the use of uroporphyric Leishmania for vaccine/drug delivery."( Transgenic Leishmania model for delta-aminolevulinate-inducible monospecific uroporphyria: cytolytic phototoxicity initiated by singlet oxygen-mediated inactivation of proteins and its ablation by endosomal mobilization of cytosolic uroporphyrin.
Chang, KP; Dutta, S; Kolli, BK; Sassa, S; Tang, A, 2008
)
0.35
"The primary objective of this augmental, prospective, uncontrolled phase II multicentre trial was to assess adverse events (AE) associated with malignant glioma resection using 5-aminolevulinic (5-ALA)."( Favorable outcome in the elderly cohort treated by concomitant temozolomide radiochemotherapy in a multicentric phase II safety study of 5-ALA.
Kern, BC; Krex, D; Mehdorn, HM; Nestler, U; Pichlmeier, U; Stockhammer, F; Stummer, W; Vince, GH, 2011
)
0.37
"Combination of surgical curettage and topical PDT has been proven to be a safe and effective procedure, and may offer a wide clinical application for the treatment of perianal condyloma acuminata."( Treatment of perianal condyloma acuminate with topical ALA-PDT combined with curettage: outcome and safety.
Cheng, QH; He, Y; Lei, X; Lu, YG; Wu, JJ; Yang, W; Yang, YD, 2012
)
0.38
" Hypotension and alteration of liver functions have been reported as potential adverse effects."( Risk factors for developing oral 5-aminolevulinic acid-induced side effects in patients undergoing fluorescence guided resection.
Chung, IW; Eljamel, S, 2013
)
0.67
" Photodynamic Therapy (PDT) is promising as it is known to ablate more proximal gastrointestinal mucosa with safe healing, without damage to underlying muscle."( Safe ablation of the anal mucosa and perianal skin in rats using Photodynamic Therapy--a promising approach for treating Anal Intraepithelial Neoplasia.
Abbasakoor, F; Boulos, P; Bown, S; Farooqui, N; MacRobert, A; Novelli, M; Woodhams, J, 2013
)
0.39
"ALA-PDT can ablate anal mucosa and peri-anal skin with safe healing and no underlying damage."( Safe ablation of the anal mucosa and perianal skin in rats using Photodynamic Therapy--a promising approach for treating Anal Intraepithelial Neoplasia.
Abbasakoor, F; Boulos, P; Bown, S; Farooqui, N; MacRobert, A; Novelli, M; Woodhams, J, 2013
)
0.39
" Over the following 2 years, some investigators noted and formally reported the continued occurrence of serious adverse events in excess of those described with other approved cutaneous PDT treatments."( Prolonged adverse events following photodynamic therapy: regulatory implications.
Anderson, SJ; Dixon, AJ; Mazzurco, JD; Steinman, HK, 2014
)
0.4
" It is of concern that this ALA product and lamp could be promoted and used widely in Australia following these reports of significant adverse events and continued lack of TGA approval."( Prolonged adverse events following photodynamic therapy: regulatory implications.
Anderson, SJ; Dixon, AJ; Mazzurco, JD; Steinman, HK, 2014
)
0.4
" Between 41% and 58% of the patients had at least 1 adverse event (AE), although predominantly mild to moderate."( Safety of hexaminolevulinate for blue light cystoscopy in bladder cancer. A combined analysis of the trials used for registration and postmarketing data.
Chang, SS; Gomella, LG; Grossman, HB; Stenzl, A; Witjes, JA; Zaak, D, 2014
)
0.4
"This combined and detailed analysis of patients from 6 HAL-BLC studies with very comparable criteria shows that HAL-BLC is safe and poses very little additional risks other than expected for WL cystoscopy for bladder tumor resection in this specific patient population."( Safety of hexaminolevulinate for blue light cystoscopy in bladder cancer. A combined analysis of the trials used for registration and postmarketing data.
Chang, SS; Gomella, LG; Grossman, HB; Stenzl, A; Witjes, JA; Zaak, D, 2014
)
0.4
" Twenty-six patients (37%) reported 44 adverse events (AEs), of which 40 were mild or moderate."( Efficacy and safety of hexaminolevulinate photodynamic therapy in patients with low-grade cervical intraepithelial neoplasia.
Ardaens, K; Collinet, P; Dannecker, C; Gallwas, J; Hillemanns, P; Luyten, A; Petry, KU; Soergel, P, 2014
)
0.4
" The data was obtained that co-administration of Pb with NPs of SiO2 and TiO2 led to changes in a number of indicators that can be interpreted as a slight increase in the toxic effect of the tested substances."( [Influence of titanium dioxide and silica nanoparticles on accumulation and toxicity of lead in experiments with intragastric co-administration].
Gmoshinskiĭ, IV; Khotimchenko, SA; Mustaphina, OK; Shumakova, AA; Soto, SKh; Trushina, ÉN, 2014
)
0.4
" All patients were able to complete the treatment protocol, with well cosmetic results and no moderate adverse reactions."( Efficacy and safety of topical ALA-PDT in the treatment of EMPD.
Fan, DL; Gao, Y; Lu, YG; Wang, HL; Wang, WS; Yang, Y; Zhang, XC, 2015
)
0.42
" Only a few patients expressed mild adverse effects."( Daylight photodynamic therapy with 1.5% 3-butenyl 5-aminolevulinate gel as a convenient, effective and safe therapy in acne treatment: A double-blind randomized controlled trial.
Kwon, HH; Lee, JB; Moon, KR; Park, SY; Suh, DH; Yoon, JY, 2016
)
0.43
"Regarding safety, the adverse drug reactions were observed as grade 1 pruritus in 1 patient (0."( The clinical trial on the safety and effectiveness of the photodynamic diagnosis of non-muscle-invasive bladder cancer using fluorescent light-guided cystoscopy after oral administration of 5-aminolevulinic acid (5-ALA).
Azuma, H; Fujimoto, K; Hirao, Y; Inoue, K; Ito, YM; Matsubara, A; Matsuyama, H; Mimata, H; Nagase, Y; Oyama, M; Ozono, S; Shiina, H; Shuin, T; Sugimura, Y; Ueno, M; Watanabe, H, 2016
)
0.62
"ALA-PDD was shown to be safe and effective."( The clinical trial on the safety and effectiveness of the photodynamic diagnosis of non-muscle-invasive bladder cancer using fluorescent light-guided cystoscopy after oral administration of 5-aminolevulinic acid (5-ALA).
Azuma, H; Fujimoto, K; Hirao, Y; Inoue, K; Ito, YM; Matsubara, A; Matsuyama, H; Mimata, H; Nagase, Y; Oyama, M; Ozono, S; Shiina, H; Shuin, T; Sugimura, Y; Ueno, M; Watanabe, H, 2016
)
0.62
" No severe adverse effects were reported."( Safety and Efficacy of 5-Aminolevulinic Acid for High Grade Glioma in Usual Clinical Practice: A Prospective Cohort Study.
Arráez, MÁ; Garcia, R; González, JJ; Montané, E; Rimbau, J; Tardáguila, M; Teixidor, P; Vidal, X; Villalba, G, 2016
)
0.74
" Treatment-emergent adverse events (TEAEs) were experienced by 100% of the BF-200 ALA group and 69% of the placebo group."( A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz(®) ) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-Rho
Aschoff, R; Berking, C; Dirschka, T; Hahn, S; Jäger, A; Lau, K; Lübbert, H; Ostendorf, R; Philipp-Dormston, WG; Reinhold, U; Schmitz, B; Szeimies, RM, 2016
)
0.43
"The combined treatment of topical ALA-PDT and curettage was proven to be safe and effective in lip florid papillomatosis."( Treatment of lip florid papillomatosis with topical ALA-PDT combined with curettage: Outcome and safety.
Gao, Y; Liu, J; Lu, YG; Wang, HL; Wang, WS, 2016
)
0.43
" The objective of this study was to evaluate the impact of antihistamines upon adverse effects following ALA-PDT."( A randomized, double-blind, placebo-controlled clinical trial evaluating the role of systemic antihistamine therapy for the reduction of adverse effects associated with topical 5-aminolevulinic acid photodynamic therapy.
Goldman, MP; Jones, IT; Vanaman Wilson, MJ; Wu, DC, 2017
)
0.65
"Local ALA-PDT combined with antibiotics is a safe and effective method of treating atypical mycobacterial skin infections."( ALA-PDT combined with antibiotics for the treatment of atypical mycobacterial skin infections: Outcomes and safety.
Gong, N; Huang, X; Lei, X; Lu, W; Qin, Q; Sun, K; Yang, H, 2017
)
0.46
" However, adverse events occur during and after treatment."( A new optical intra-tissue fiber irradiation ALA-PDT in the treatment of acne vulgaris in rabbit model: improved safety and tolerability.
Chen, J; Duan, X; Huang, X; Jiang, C; Lin, X; Liu, W; Wang, Q,
)
0.13
" Uncomfortable symptoms, adverse events, and effectiveness rates were recorded on post-treatment day 14, 30, and 45."( A new optical intra-tissue fiber irradiation ALA-PDT in the treatment of acne vulgaris in rabbit model: improved safety and tolerability.
Chen, J; Duan, X; Huang, X; Jiang, C; Lin, X; Liu, W; Wang, Q,
)
0.13
" The adverse event rate in OFI-ALA-PDT group was obviously lower than that of the ALA-PDT group (P<0."( A new optical intra-tissue fiber irradiation ALA-PDT in the treatment of acne vulgaris in rabbit model: improved safety and tolerability.
Chen, J; Duan, X; Huang, X; Jiang, C; Lin, X; Liu, W; Wang, Q,
)
0.13
" None of the 12 adverse events during surveillance were serious."( Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study.
Bivalacqua, T; Daneshmand, S; DeCastro, J; Downs, T; Huang, W; Jones, J; Jones, JS; Kamat, A; Konety, B; Lotan, Y; O'Donnell, M; Patel, S; Pohar, K; Resnick, M; Schoenberg, M; Steinberg, G; Trabulsi, E; Woods, M, 2018
)
0.48
"Office based blue light flexible cystoscopy significantly improves the detection of patients with recurrent bladder cancer and it is safe when used for surveillance."( Efficacy and Safety of Blue Light Flexible Cystoscopy with Hexaminolevulinate in the Surveillance of Bladder Cancer: A Phase III, Comparative, Multicenter Study.
Bivalacqua, T; Daneshmand, S; DeCastro, J; Downs, T; Huang, W; Jones, J; Jones, JS; Kamat, A; Konety, B; Lotan, Y; O'Donnell, M; Patel, S; Pohar, K; Resnick, M; Schoenberg, M; Steinberg, G; Trabulsi, E; Woods, M, 2018
)
0.48
" Mild or moderate adverse effects were similar for both groups."( Effectiveness and safety of 0·5% colchicine cream vs. photodynamic therapy with methyl aminolaevulinate in the treatment of actinic keratosis and skin field cancerization of the forearms: a randomized controlled trial.
Abbade, LPF; Ferreira, ER; Lima, TRR; Miola, AC; Miot, HA; Schmitt, JV, 2018
)
0.48
"COL 0·5% cream and MAL-PDT are safe and effective for treating SFC."( Effectiveness and safety of 0·5% colchicine cream vs. photodynamic therapy with methyl aminolaevulinate in the treatment of actinic keratosis and skin field cancerization of the forearms: a randomized controlled trial.
Abbade, LPF; Ferreira, ER; Lima, TRR; Miola, AC; Miot, HA; Schmitt, JV, 2018
)
0.48
" Thus, in this review, we evaluate the mechanisms of action and adverse effects of common medications used to treat type 2 diabetes mellitus as well as 5-ALA including its mechanism and possible use in diabetes management."( Safety and Mode of Action of Diabetes Medications in comparison with 5-Aminolevulinic Acid (5-ALA).
Iftikhar, H; Jabbar, Z; Nakajima, M; Rehani, PR; Rehani, RN; Tanaka, T, 2019
)
0.75
"This study was designed to compare the efficacy, the adverse effects and the costs of 10 % and 20 % ALA-PDT for AK treatment."( Comparison of efficacy, adverse effects and costs between 20 % ALA-PDT and 10 % ALA-PDT for the treatment of actinic keratosis in Chinese patients.
Cao, Z; Shi, L; Wang, P; Wang, X; Zhang, G; Zhang, L; Zho, Z; Zhu, L, 2020
)
0.56
"We reviewed the records of patients who had received ALA-PDT in our department between January 1, 2012, and April 30, 2017, the efficacy, the adverse effects were recorded, and the costs were analyzed."( Comparison of efficacy, adverse effects and costs between 20 % ALA-PDT and 10 % ALA-PDT for the treatment of actinic keratosis in Chinese patients.
Cao, Z; Shi, L; Wang, P; Wang, X; Zhang, G; Zhang, L; Zho, Z; Zhu, L, 2020
)
0.56
"A total of 59 AK patients' records were analyzed for the efficacy, the adverse events, the recurrence and the costs."( Comparison of efficacy, adverse effects and costs between 20 % ALA-PDT and 10 % ALA-PDT for the treatment of actinic keratosis in Chinese patients.
Cao, Z; Shi, L; Wang, P; Wang, X; Zhang, G; Zhang, L; Zho, Z; Zhu, L, 2020
)
0.56
"10 % ALA-PDT has similar efficacy and adverse effects as 20 % ALA-PDT with lower costs."( Comparison of efficacy, adverse effects and costs between 20 % ALA-PDT and 10 % ALA-PDT for the treatment of actinic keratosis in Chinese patients.
Cao, Z; Shi, L; Wang, P; Wang, X; Zhang, G; Zhang, L; Zho, Z; Zhu, L, 2020
)
0.56
" Any adverse event occurring during/after ALA application/irradiation as well as pain intensity were recorded at each visit."( Efficacy and safety of conventional versus daylight photodynamic therapy in children affected by multiple facial flat warts.
Borgia, F; Cannavò, SP; Coppola, M; Giuffrida, R; Guarneri, F; Princiotta, R; Vaccaro, M, 2020
)
0.56
"ALA-PDT is effective and safe for FFWs, with striking cosmetic results and no recurrence."( Efficacy and safety of conventional versus daylight photodynamic therapy in children affected by multiple facial flat warts.
Borgia, F; Cannavò, SP; Coppola, M; Giuffrida, R; Guarneri, F; Princiotta, R; Vaccaro, M, 2020
)
0.56
" ALA-related adverse effects included vomiting (seven cases), hypotension (seven cases, two of which were severe), and liver toxicity (four cases)."( Real-world experience with 5-aminolevulinic acid for the photodynamic diagnosis of bladder cancer: Diagnostic accuracy and safety.
Fukuhara, H; Inoue, K; Karashima, T; Yamamoto, S, 2020
)
0.85
" Three adverse events were considered related to the drug; however, these had no significant correlation with the drug concentration or application time."( Photodetection and Safety of 5-Aminolevulinic Acid-Induced Porphyrin in Patients With Cervical Intraepithelial Neoplasia.
Bai, W; Cao, F; Chen, R; Cui, Y; Dong, Y; Shi, Y; Tao, J; Xu, J; Zhao, J; Zhao, X, 2021
)
0.91
"5-ALA at 10%-30% concentration is safe in patients with CIN."( Photodetection and Safety of 5-Aminolevulinic Acid-Induced Porphyrin in Patients With Cervical Intraepithelial Neoplasia.
Bai, W; Cao, F; Chen, R; Cui, Y; Dong, Y; Shi, Y; Tao, J; Xu, J; Zhao, J; Zhao, X, 2021
)
0.91
" This study aimed to evaluate the efficacy and adverse effects of 5-aminolevulinic acid (ALA)-PDT in VEN treatment with a long-term follow-up."( Safety and effectiveness of 5-aminolevulinic acid photodynamic therapy combined with fractional micro-plasma radio-frequency treatment for verrucous epidermal nevus: A retrospective study with long-term follow-up.
Chen, P; Dai, S; Guo, J; He, S; Huang, X; Li, Q; Shen, J; Zeng, K; Zhu, M, 2021
)
1.15
"ALA-PDT was safe and partially effective in reducing DCS symptoms as an adjunct to systemic medicinal therapies."( The efficacy and safety of 5-Aminolevulinic acid photodynamic therapy (ALA-PDT) as an adjunct therapy for symptoms in patients with dissecting cellulitis of the scalp: A retrospective study.
Feng, H; Jin, H; Zhu, C, 2021
)
0.91
" Affecting factors of the efficacy of PDT and adverse events were also assessed during treatment."( Efficacy and safety of photodynamic therapy mediated by 5-aminolevulinic acid for the treatment of cervical intraepithelial neoplasia 2: A single-center, prospective, cohort study.
Gao, X; Geng, L; Guo, H; Han, Q; Li, Y; Ma, L; Wang, Y; Wu, Z; You, K, 2021
)
0.87
"PDT can be a safe and efficient treatment for CIN2."( Efficacy and safety of photodynamic therapy mediated by 5-aminolevulinic acid for the treatment of cervical intraepithelial neoplasia 2: A single-center, prospective, cohort study.
Gao, X; Geng, L; Guo, H; Han, Q; Li, Y; Ma, L; Wang, Y; Wu, Z; You, K, 2021
)
0.87
" The main adverse effects in ALA-PDT treatment were mild edema and tolerable pain, and no adverse effect was observed in red-light treatment."( Treatment of androgenetic alopecia with 5-aminolevulinic acid photodynamic therapy: A randomized, placebo-controlled, split-scalp study of efficacy and safety.
Cao, Z; Hu, W; Liu, X; Wang, P; Wang, X; Zhang, G; Zhang, L; Zhang, Y; Zhou, Z, 2021
)
0.89
" The adverse effects of ALA-PDT were mild, which indicated safety and tolerability of this treatment."( Treatment of androgenetic alopecia with 5-aminolevulinic acid photodynamic therapy: A randomized, placebo-controlled, split-scalp study of efficacy and safety.
Cao, Z; Hu, W; Liu, X; Wang, P; Wang, X; Zhang, G; Zhang, L; Zhang, Y; Zhou, Z, 2021
)
0.89
" We systematically searched MEDLINE, Embase, and the Cochrane Library for clinical studies of treatment efficacy or adverse events."( Bringing the gentle properties of daylight photodynamic therapy indoors: A systematic review of efficacy and safety.
Heerfordt, IM; Philipsen, PA; Wulf, HC, 2022
)
0.72
" However, its development is still restricted by low targeting, high dose and toxic side effects."( A multimodal Metal-Organic framework based on unsaturated metal site for enhancing antitumor cytotoxicity through Chemo-Photodynamic therapy.
Ding, Q; Li, B; Li, W; Liu, J; Muddassir, M; Ouyang, Q; Rao, C; Sakiyama, H; Xu, Z; Zhou, L, 2022
)
0.72
" The most common adverse event was increased vaginal discharge, other side effects include abdominal pain, vulvar pruritus, and vaginal bleeding."( Efficacy and safety of photodynamic therapy mediatied by 5-aminolevulinic acid for the treatment of vaginal high-grade intraepithelial lesions.
Guo, H; Han, Q; Wu, Z; Zhang, X, 2022
)
0.96
"Photodynamic therapy mediatied by 5-aminolevulinic acid is an effective and safe treatment for vaginal HSIL with minimal side effects."( Efficacy and safety of photodynamic therapy mediatied by 5-aminolevulinic acid for the treatment of vaginal high-grade intraepithelial lesions.
Guo, H; Han, Q; Wu, Z; Zhang, X, 2022
)
1.24
" Adverse events (AEs) were recorded, and the safety of repeat use of HAL was determined by comparing the proportion of patients with AEs considered causally related to HAL in the surveillance examination compared to the OR examination."( Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study.
Bivalacqua, TJ; Daneshmand, S; DeCastro, J; Downs, T; Huang, WC; Jones, J; Jones, JS; Kamat, AM; Konety, B; Lotan, Y; O'Donnell, M; Patel, S; Pohar, KS; Resnick, MJ; Schoenberg, M; Steinberg, G; Taylor, J; Trabulsi, E; Woods, M, 2022
)
0.72
"Repeat use of HAL is safe even when administered within a few weeks of receiving a dose of intravesical therapy."( Safety of repeat blue light cystoscopy with hexaminolevulinate (HAL) in the management of bladder cancer: Results from a phase III, comparative, multi-center study.
Bivalacqua, TJ; Daneshmand, S; DeCastro, J; Downs, T; Huang, WC; Jones, J; Jones, JS; Kamat, AM; Konety, B; Lotan, Y; O'Donnell, M; Patel, S; Pohar, KS; Resnick, MJ; Schoenberg, M; Steinberg, G; Taylor, J; Trabulsi, E; Woods, M, 2022
)
0.72
" These treatment methods involvevarious adverse reactions; therefore, it remains necessary to explore new treatment methods."( Enhancement of the cytotoxic effect of dihydroartemisinin in high-risk human papillomavirus-infected cells by aminolevulinic acid via the Bax/Bcl-2-caspase pathway.
Che, Q; Li, C; Lu, H; Wang, Q; Zeng, K, 2022
)
0.93
" The adverse reactions after PDT were mild, mainly manifested as increased vaginal secretions or burning/tingling."( Evaluation of the efficacy and safety of 5-aminolevulinic acid-mediated photodynamic therapy in women with high-risk HPV persistent infection after cervical conization.
Huang, Y; Jia, L; Liu, X; Liu, Y; Wang, L; Zhang, J; Zhang, Y, 2022
)
0.98
"To evaluate which method has the best efficacy and cosmetic results with less adverse events and recurrence rate."( Efficacy and Safety of Photodynamic Therapy for the Treatment of Actinic Keratoses: A Meta-Analysis Update of Randomized Controlled Trials.
Hu, C; Jiang, C; Lei, S; Luo, X; Sun, Y, 2023
)
0.91
" Extract and analyze the data of efficacy, cosmetic results, local reactions, and adverse effects."( Efficacy and Safety of Photodynamic Therapy for the Treatment of Actinic Keratoses: A Meta-Analysis Update of Randomized Controlled Trials.
Hu, C; Jiang, C; Lei, S; Luo, X; Sun, Y, 2023
)
0.91
"Compared with other methods, PDT is significantly more effective for AK with excellent cosmetic results and reversible adverse effects."( Efficacy and Safety of Photodynamic Therapy for the Treatment of Actinic Keratoses: A Meta-Analysis Update of Randomized Controlled Trials.
Hu, C; Jiang, C; Lei, S; Luo, X; Sun, Y, 2023
)
0.91
"The ALA-PDL-PDT protocol is a safe and well-tolerated treatment option for isSCC on the face, providing excellent cosmetic and functional results."( Evaluating the safety and efficacy of aminolevulinic acid 20% topical solution activated by pulsed dye laser and blue light in the treatment of facial cutaneous squamous cell carcinoma in situ.
Ceci, FM; Gade, A; Han, H; Lawson, A; Nestor, MS, 2023
)
1.18
" Although this study suggests safe administration and the possibility of ALA improving hand grip strength in patients with sarcopenia, further investigation is required."( Efficacy and Safety of 5-Aminolevulinic Acid Combined with Iron on Skeletal Muscle Mass Index and Physical Performance of Patients with Sarcopenia: A Multicenter, Double-Blinded, Randomized-Controlled Trial (ALADDIN Study).
Abe, Y; Hiyoshi, T; Inoue, I; Kaga, H; Kuribayashi, N; Seino, H; Tamura, Y; Watada, H; Yoshii, H, 2023
)
1.21

Pharmacokinetics

ExcerptReferenceRelevance
" Subsequent elimination from plasma was monoexponential with a half-life of 6 +/- 1 days."( Pharmacokinetics of PEG-L-asparaginase and plasma and cerebrospinal fluid L-asparagine concentrations in the rhesus monkey.
Balis, FM; Berg, SL; Godwin, KS; McCully, CL; Poplack, DG, 1993
)
0.29
" administration declined rapidly with a terminal half-life of 19."( Pharmacokinetics of aminolevulinic acid after oral and intravenous administration in dogs.
Dalton, JT; Golub, AL; Meyer, MC, 1999
)
0.63
" ALA terminal half-life was approximately 45 min after intravenous or oral administration."( Clinical pharmacokinetics of 5-aminolevulinic acid in healthy volunteers and patients at high risk for recurrent bladder cancer.
Dalton, JT; Golub, AL; Marcus, SL; Meyer, MC; Straughn, A; Yates, CR; Yin, D, 2002
)
0.6
" Pharmacokinetic (PK) data from these individual studies were pooled and analyzed."( Clinical pharmacokinetics of the PDT photosensitizers porfimer sodium (Photofrin), 2-[1-hexyloxyethyl]-2-devinyl pyropheophorbide-a (Photochlor) and 5-ALA-induced protoporphyrin IX.
Bellnier, DA; Dougherty, TJ; Greco, WR; Loewen, GM; Nava, H; Oseroff, AR, 2006
)
0.33
" Using h-ALA, the peak concentration of protoporphyrin IX was achieved 20%-25% more quickly with 3- or 6-mM solutions than with ALA."( Pharmacokinetics of the photosensitizers aminolevulinic acid and aminolevulinic acid hexylester in oro-facial tumors embedded in the chorioallantois membrane of a hen's egg.
Foth, HJ; Hoppenheit, C; Hüttenberger, D; Müller-Richter, UD; Reichert, TE; Spitzer, WJ, 2006
)
0.6
"Using h-ALA, the peak concentration of protoporphyrin IX, compared to ALA, is achieved 20% percent more quickly and with twice as much contrast between tumorous and healthy tissue (1:11 compared and 1:5, respectively)."( Pharmacokinetics of the photosensitizers aminolevulinic acid and aminolevulinic acid hexylester in oro-facial tumors embedded in the chorioallantois membrane of a hen's egg.
Foth, HJ; Hoppenheit, C; Hüttenberger, D; Müller-Richter, UD; Reichert, TE; Spitzer, WJ, 2006
)
0.6
" The pharmacodynamic effect of the enzyme was studied through changes in plasma porphobilinogen concentrations."( Safety, pharmacokinetics and pharmocodynamics of recombinant human porphobilinogen deaminase in healthy subjects and asymptomatic carriers of the acute intermittent porphyria gene who have increased porphyrin precursor excretion.
Andersson, DE; Harper, P; Rejkjaer, L; Sardh, E, 2007
)
0.34
" The studies investigated the influence of patch application duration on PPIX-specific fluorescence and the pharmacokinetic properties of the 5-ALA patch."( Fluorescence characteristics and pharmacokinetic properties of a novel self-adhesive 5-ALA patch for photodynamic therapy of actinic keratoses.
Ackermann, G; Birkel, M; Breuer, M; Ebeling, A; Fauteck, JD; Moor, AC; Ortland, C, 2008
)
0.35
" The clearance half-life of EDTA-induced PpIX was 4-7 times longer than that of PpIX after application of ALA."( Clearance mechanism of protoporphyrin IX from mouse skin after application of 5-aminolevulinic acid.
Iani, V; Juzeniene, A; Moan, J, 2013
)
0.62
" This phase I study evaluated the safety, pharmacokinetic, and pharmacodynamic profile of subcutaneously (SC) administered givosiran in patients with acute intermittent porphyria, the most common AHP type."( Pharmacokinetics and Pharmacodynamics of the Small Interfering Ribonucleic Acid, Givosiran, in Patients With Acute Hepatic Porphyria.
Agarwal, S; Clausen, VA; Goel, V; Habtemariam, BA; Kim, JB; Robbie, GJ; Simon, AR, 2020
)
0.56
" To characterize systemic absorption from dermal application during PDT, ALA and its key active metabolite protoporphyrin IX (PpIX) were analyzed in 2 maximal usage pharmacokinetic trials (MUsT) in patients severely affected with actinic keratosis."( Clinical Pharmacokinetics and Safety of a 10% Aminolevulinic Acid Hydrochloride Nanoemulsion Gel (BF-200 ALA) in Photodynamic Therapy of Patients Extensively Affected With Actinic Keratosis: Results of 2 Maximal Usage Pharmacokinetic Trials.
Chahrour, O; DuBois, J; Hirt, S; Lübbert, H; Novak, B; Osenberg, K; Papusha, T; Philippi, T; Schmitz, B; Zogel, C, 2022
)
0.98
" As a small interfering RNA that is selectively taken up in the liver, both the mechanism and targeted delivery create a complex relationship between givosiran pharmacokinetics (PK) and the pharmacodynamic (PD) response."( Pharmacokinetic-pharmacodynamic model of urinary δ-aminolevulinic acid reduction after givosiran treatment in patients with acute hepatic porphyria.
Lee, J; Melch, M; Robbie, GJ, 2023
)
1.16

Compound-Compound Interactions

This article explores the effect of 5-aminolevulinic acid (5-ALA)-mediated photodynamic therapy (PDT) combined with cisplatin (CDDP) on the apoptosis of human ovarian cancer cells and the mechanism of action of the combination therapy.

ExcerptReferenceRelevance
"This study reports our first results of ambulant photodynamic treatment with 5-aminolevulinic acid (5-ALA) in combination with folic acid and subsequent illumination with a noncoherent light source."( Ambulant photodynamic therapy of superficial malignomas with 5-ALA in combination with folic acid and use of noncoherent light.
Alth, G; Dobrowsky, W; Jindra, RH; Kolbabek, H; Kubin, A, 1999
)
0.53
" We have investigated the effect of 5-ALA mediated PDT in combination with gamma-irradiation on the colony forming ability of several human head and neck tumour cell lines."( Effect of photodynamic therapy in combination with ionizing radiation on human squamous cell carcinoma cell lines of the head and neck.
Allman, R; Cowburn, P; Mason, M, 2000
)
0.31
"For our investigation we used Balb/c mice implanted with Lewis sarcoma and irradiated with 3 Gy combined with injection of 5-ALA or Photofrin at various concentrations before irradiation."( Radiation therapy combined with photofrin or 5-ALA: effect on Lewis sarcoma tumor lines implanted in mice. Preliminary results.
Corti, L; Dühmke, E; Hofstetter, A; Jori, G; Schaffer, M; Schaffer, PM; Sotti, G,
)
0.13
"In this study, the effect of lipophilic counter-ions on the permeation of 5-aminolevulinic acid (ALA) in combination with skin impregnation by phloretin and 6-ketocholestanol was evaluated."( Influence of lipophilic counter-ions in combination with phloretin and 6-ketocholestanol on the skin permeation of 5-aminolevulinic acid.
Auner, BG; Hadgraft, J; Valenta, C, 2003
)
0.76
"Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX was found as a valuable tool in the diagnosis of oral premalignancy."( Fluorescence spectroscopy combined with 5-aminolevulinic acid-induced protoporphyrin IX fluorescence in detecting oral premalignancy.
El-Maaytah, M; Hopper, C; Jerjes, W; Khalil, HS; MacRobert, AJ; Salih, V; Sharwani, A, 2006
)
0.86
" Cosmetically well-accepted, LP PDL PDT combined with topical therapy is the first PDT modality to achieve complete clearance with long-term follow-up as compared to controls."( Long-pulsed dye laser-mediated photodynamic therapy combined with topical therapy for mild to severe comedonal, inflammatory, or cystic acne.
Alexiades-Armenakas, M, 2006
)
0.33
" Searching for new approaches, we tested a known inducer of cellular differentiation, methotrexate (MTX), in combination with ALA-PDT in LNCaP cells."( Methotrexate used in combination with aminolaevulinic acid for photodynamic killing of prostate cancer cells.
Anand, S; Chang, Y; Hasan, T; Mai, Z; Maytin, EV; Ortel, BJ; Sinha, AK, 2006
)
0.33
" The study reported herein evaluated the effect on acne vulgaris of IPL alone and when IPL was combined with photodynamic therapy (PDT) using topical methyl aminolevulinate (MAL) in Asians."( A comparative study of intense pulsed light alone and its combination with photodynamic therapy for the treatment of facial acne in Asian skin.
Bjerring, P; Chan, HH; Kono, T; Shek, SY; Yeung, CK; Yu, CS, 2007
)
0.34
"5% in liposomal spray and intense pulsed light (IPL) in combination with topical peeling agents (Li-PDT-PC) in acne vulgaris."( Photodynamic therapy of acne vulgaris using 5-aminolevulinic acid 0.5% liposomal spray and intense pulsed light in combination with topical keratolytic agents.
Bjerring, P; de Leeuw, J; Neumann, HA; van der Beek, N, 2010
)
0.62
"5% liposomal spray and IPL in combination with topical peeling agents is safe and efficacious, even in patients with acne recalcitrant to standard therapy."( Photodynamic therapy of acne vulgaris using 5-aminolevulinic acid 0.5% liposomal spray and intense pulsed light in combination with topical keratolytic agents.
Bjerring, P; de Leeuw, J; Neumann, HA; van der Beek, N, 2010
)
0.62
" Here, we characterized the response of subcutaneous syngeneic Colon26 murine colon adenocarcinoma tumors to PDT using the locally applied photosensitizer precursor aminolevulinic acid (ALA) in combination with a topical formulation of vadimezan."( Aminolevulinic acid-photodynamic therapy combined with topically applied vascular disrupting agent vadimezan leads to enhanced antitumor responses.
Becker, T; Bellnier, D; Marrero, A; Morgan, J; Sunar, U,
)
1.77
"•  To discuss how the development of new generation flexible ureterorenoscopes in combination with photodynamic diagnosis (PDD) improves the assessment of urothelial cell carcinoma of the upper urinary tract (UUT-UCC)."( Potential role of photodynamic techniques combined with new generation flexible ureterorenoscopes and molecular markers for the management of urothelial carcinoma of the upper urinary tract.
Audenet, F; Cussenot, O; Rouprêt, M; Traxer, O; Yates, DR, 2012
)
0.38
" •  The traditional pitfalls of UUT-UCC diagnosis, namely poor visualisation and difficulty in obtaining representative histological samples, are being circumvented by the introduction of modern digital flexible ureteroscopes that can be combined with PDD and molecular analysis to improve tumour classification, deferring to conservative treatment accordingly."( Potential role of photodynamic techniques combined with new generation flexible ureterorenoscopes and molecular markers for the management of urothelial carcinoma of the upper urinary tract.
Audenet, F; Cussenot, O; Rouprêt, M; Traxer, O; Yates, DR, 2012
)
0.38
"The purpose of this study was to evaluate the treatment outcome and safety of topical photodynamic therapy (PDT) with aminolevulinic acid (5-ALA) combined with surgical curettage for perianal condyloma acuminata."( Treatment of perianal condyloma acuminate with topical ALA-PDT combined with curettage: outcome and safety.
Cheng, QH; He, Y; Lei, X; Lu, YG; Wu, JJ; Yang, W; Yang, YD, 2012
)
0.59
"In this study, 40 cases of perianal condyloma acuminata were treated with topical aminolevulinic acid photodynamic therapy (ALA-PDT) combined with curettage."( Treatment of perianal condyloma acuminate with topical ALA-PDT combined with curettage: outcome and safety.
Cheng, QH; He, Y; Lei, X; Lu, YG; Wu, JJ; Yang, W; Yang, YD, 2012
)
0.6
"To investigate the efficacy, adverse reaction and prognosis of liquid nitrogen freezing combined with 5-aminolaevulinic acid-photodynamic therapy (ALA-PDT) in the treatment of condyloma acuminatum in men."( [Liquid nitrogen freezing combined with 5-aminolaevulinic acid-photodynamic therapy for condyloma acuminatum in men].
Li, CT; Song, QH; Wang, J, 2012
)
0.38
"We collected medical histories and conducted physical examinations for 35 male patients with condyloma acuminatum in the outpatient department, and treated them by liquid nitrogen freezing combined with ALA-PDT every 7-10 days."( [Liquid nitrogen freezing combined with 5-aminolaevulinic acid-photodynamic therapy for condyloma acuminatum in men].
Li, CT; Song, QH; Wang, J, 2012
)
0.38
"Liquid nitrogen freezing combined with ALA-PDT is better than either liquid nitrogen freezing or ALA-PDT alone for the treatment of condyloma acuminatum in men."( [Liquid nitrogen freezing combined with 5-aminolaevulinic acid-photodynamic therapy for condyloma acuminatum in men].
Li, CT; Song, QH; Wang, J, 2012
)
0.38
" In order to assist in optimizing treatment, we applied 5-ALA/PDT in combination with low-dose cisplatin to evaluate cytotoxicity in Hela cells."( Synergistic anticancer activity of 5-aminolevulinic acid photodynamic therapy in combination with low-dose cisplatin on Hela cells.
Liu, AH; Ma, HQ; Wei, XQ; Zhang, YZ, 2013
)
0.66
" In addition, it was confirmed that exposure of Hela cells to 5-ALA/PDT in combination with low-dose cisplatin resulted in more apoptosis in vitro."( Synergistic anticancer activity of 5-aminolevulinic acid photodynamic therapy in combination with low-dose cisplatin on Hela cells.
Liu, AH; Ma, HQ; Wei, XQ; Zhang, YZ, 2013
)
0.66
"Our findings suggest that administration of 5-ALA/PDT in combination with the low-dose cisplatin may be an effective and feasible therapy for cervical cancer."( Synergistic anticancer activity of 5-aminolevulinic acid photodynamic therapy in combination with low-dose cisplatin on Hela cells.
Liu, AH; Ma, HQ; Wei, XQ; Zhang, YZ, 2013
)
0.66
" HO-1 expression induced by 5-ALA combined with SFC (5-ALA/SFC) was partially inhibited by MEK/ERK and p38 MAPK inhibitor."( 5-Aminolevulinic acid combined with ferrous iron enhances the expression of heme oxygenase-1.
Abe, F; Fujino, M; Ishii, T; Ishizuka, M; Ito, H; Li, XK; Nagahara, Y; Nakajima, M; Nishio, Y; Takahashi, K; Taketani, S; Tanaka, T; Zhao, M, 2014
)
1.12
"Our previous study showed successful treatment of a large oral verrucous hyperplasia (OVH) with topical 5-aminolevulinic acid-mediated photodynamic therapy combined with cryotherapy (ALA-PDT)."( Successful treatment of oral verrucous hyperplasia with photodynamic therapy combined with cryotherapy--report of 3 cases.
Chang, YC; Yu, CH, 2014
)
0.62
" The purpose of this study was to evaluate the efficacy of topical PDT using aminolevulinic acid (5-ALA) combined with excision in the treatment of skin malignant tumor and its role in surgical improvements."( Efficacy of topical ALA-PDT combined with excision in the treatment of skin malignant tumor.
Gao, Y; Li, GL; Lu, YG; Wang, YY; Yang, Y; Yang, YD; Zhang, JB; Zhang, XC, 2014
)
0.63
" We treated one case of chromoblastomycosis by photodynamic therapy (PDT) of 5-aminolevulinic acid (ALA) irradiation combined with terbinafine 250 mg a day."( Photodynamic therapy combined with terbinafine against chromoblastomycosis and the effect of PDT on Fonsecaea monophora in vitro.
Hamblin, MR; Hu, Y; Huang, X; Lu, S; Mylonakis, E; Xi, L; Zhang, J, 2015
)
0.64
" In this study, we evaluated the feasibility and efficacy of aminolevulinic acid (ALA) as a photosensitizer (ALA-PDT) in combination with CO2 laser in the treatment of Bowen's disease (BD; intraepithelial squamous cell carcinoma)."( Photodynamic therapy in combination with CO2 laser for the treatment of Bowen's disease.
Cai, H; Li, Q; Li, YL; Liu, W; Liu, XY; Sun, P; Wang, YX; Yang, ZY; Zheng, JC, 2015
)
0.66
" However, there have been few previous in vivo investigations of the relative potency and methodology of fractional radiofrequency (RF) combined with sonophoresis."( Fractional radiofrequency combined with sonophoresis to facilitate skin penetration of 5-aminolevulinic acid.
Bae, MI; Jeong, KH; Kim, NI; Lee, SJ; Park, JM; Shin, MK, 2016
)
0.66
"The PDT combined with a topical photosensitizer 5-aminolevulinic acid (ALA) and an intravenously injected light-sensitive agent hematoporphyrin derivative (HPD) was used to treat 26 patients with 41 skin cancer lesions in head and face."( A photodynamic therapy combined with topical 5-aminolevulinic acid and systemic hematoporphyrin derivative is more efficient but less phototoxic for cancer.
Lin, Y; Wang, Y; Zhang, HG; Zhu, J, 2016
)
0.94
"This article describes the case of 5-Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) via self-retaining laryngoscope under general anesthesia combined with CO2 Laser Therapy in the treatment of three patients with juvenile laryngeal papilloma."( 5-Aminolevulinic Acid Photodynamic Therapy combined with CO2 laser therapy in treatment of laryngeal papilloma: Case report.
Huang, Z; Yang, Y; Zhang, Y; Zou, X, 2016
)
1.43
" So we used surgery combined with topical photodynamic therapy (PDT) to treat SCC of the lip."( Surgery combined with topical photodynamic therapy for the treatment of squamous cell carcinoma of the lip.
Lu, Y; Wang, Y; Yang, Y, 2016
)
0.43
" The purpose of this study was to evaluate the treatment outcome and safety of PDT with aminolevulinic acid (5-ALA) combined with surgical curettage for lip florid papillomatosis."( Treatment of lip florid papillomatosis with topical ALA-PDT combined with curettage: Outcome and safety.
Gao, Y; Liu, J; Lu, YG; Wang, HL; Wang, WS, 2016
)
0.66
"In this study, 4 cases of lip florid papillomatosis were treated with topical aminolevulinic acid photodynamic therapy (ALA-PDT) combined with curettage."( Treatment of lip florid papillomatosis with topical ALA-PDT combined with curettage: Outcome and safety.
Gao, Y; Liu, J; Lu, YG; Wang, HL; Wang, WS, 2016
)
0.66
" In the present study, we investigated the effects of ALA combined with sodium ferrous citrate (SFC) on obesity and glucose intolerance in diet-induced obese mice."( 5-aminolevulinic acid combined with ferrous ion reduces adiposity and improves glucose tolerance in diet-induced obese mice via enhancing mitochondrial function.
Fukuhara, H; Hara, T; Inoue, K; Ishizuka, M; Kamiya, A; Kitajima, Y; Koda, A; Kuroda, Y; Nakagawa, H; Nakajima, M; Ota, U; Shuin, T; Tanaka, T; Tsuda, M; Tsuru, E, 2017
)
1.18
" The DIO mice were orally administered ALA combined with SFC (ALA/SFC) for 6 weeks."( 5-aminolevulinic acid combined with ferrous ion reduces adiposity and improves glucose tolerance in diet-induced obese mice via enhancing mitochondrial function.
Fukuhara, H; Hara, T; Inoue, K; Ishizuka, M; Kamiya, A; Kitajima, Y; Koda, A; Kuroda, Y; Nakagawa, H; Nakajima, M; Ota, U; Shuin, T; Tanaka, T; Tsuda, M; Tsuru, E, 2017
)
1.18
" The aim of this study was to evaluate the efficacy and safety of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) combined with antibiotics for the treatment of atypical mycobacterial skin infections."( ALA-PDT combined with antibiotics for the treatment of atypical mycobacterial skin infections: Outcomes and safety.
Gong, N; Huang, X; Lei, X; Lu, W; Qin, Q; Sun, K; Yang, H, 2017
)
0.69
"In this study, 4 patients with atypical mycobacterial skin infections were treated with ALA-PDT combined with antibiotic therapy."( ALA-PDT combined with antibiotics for the treatment of atypical mycobacterial skin infections: Outcomes and safety.
Gong, N; Huang, X; Lei, X; Lu, W; Qin, Q; Sun, K; Yang, H, 2017
)
0.46
"Local ALA-PDT combined with antibiotics is a safe and effective method of treating atypical mycobacterial skin infections."( ALA-PDT combined with antibiotics for the treatment of atypical mycobacterial skin infections: Outcomes and safety.
Gong, N; Huang, X; Lei, X; Lu, W; Qin, Q; Sun, K; Yang, H, 2017
)
0.46
"Comparison of the fluorescence intensity caused by the accumulation of PpIX in endometrial cancer xenografts in nude mice after low-dose 5-Aminolevulinic acid (ALA) injection combined with siRNA transfection was mediated by ultrasound microbubbles and polyethyleneimine (PEI) to explore the feasibility of the ultrasound microbubble technique as transfection agents."( Comparative Study of the Effects of Ferrochelatase-siRNA Transfection Mediated by Ultrasound Microbubbles and Polyethyleneimine in Combination with Low-dose ALA to Enhance PpIX Accumulation in Human Endometrial Cancer Xenograft Nude Mice Models.
Chen, L; Gao, L; Gao, X; Huang, X; Li, N; Lin, S; Song, Y; Wang, X; Zhang, X, 2019
)
0.72
" The results of combination index indicated that HBO combination with PDT synergistically inhibited A431 cells proliferation in vitro."( Hyperbaric Oxygen Combined with 5-Aminolevulinic Acid Photodynamic Therapy Inhibited Human Squamous Cell Proliferation.
Fang, F; Mei, LH; Yang, G, 2019
)
0.79
"To investigate the safety and efficacy of wide local excision combined with aminolevulinic acid (ALA) photodynamic therapy (PDT) for the treatment of scrotal Paget's disease in patients of advanced age."( Excision combined with photodynamic therapy for scrotal Paget's disease in patients aged over 60 years.
Chen, M; Chen, X; Dai, Y; Li, D; Yang, Z; Zhang, X, 2020
)
0.79
"44 years) with scrotal Paget's disease treated with wide local excision combined with ALA PDT and followed up from June 2014 to February 2018."( Excision combined with photodynamic therapy for scrotal Paget's disease in patients aged over 60 years.
Chen, M; Chen, X; Dai, Y; Li, D; Yang, Z; Zhang, X, 2020
)
0.56
"Wide local excision combined with ALA PDT shows good clinical efficacy and a low complication rate in patients of advanced age with scrotal Paget's disease."( Excision combined with photodynamic therapy for scrotal Paget's disease in patients aged over 60 years.
Chen, M; Chen, X; Dai, Y; Li, D; Yang, Z; Zhang, X, 2020
)
0.56
" The purpose of this article was to study the anti-tumor effect of ALA-PDT combined with limited excision in periocular basal cell carcinoma (BCC) and its role in improving the effect of the operation."( Ocular preservation through limited tumor excision combined with ALA-PDT in patients with periocular basal cell carcinoma.
Kou, H; Li, G; Li, X; Lu, Y; Tan, L; Wang, Y; Zhang, J, 2019
)
0.51
"In our study, 8 patients with periocular basal cell carcinoma were treated with topical aminolevulinic acid photodynamic therapy (ALA-PDT) combined with surgery."( Ocular preservation through limited tumor excision combined with ALA-PDT in patients with periocular basal cell carcinoma.
Kou, H; Li, G; Li, X; Lu, Y; Tan, L; Wang, Y; Zhang, J, 2019
)
0.74
"PDT in combination with limited surgery is a safe, effective and minimally-invasive approach for treating orbital BCC."( Ocular preservation through limited tumor excision combined with ALA-PDT in patients with periocular basal cell carcinoma.
Kou, H; Li, G; Li, X; Lu, Y; Tan, L; Wang, Y; Zhang, J, 2019
)
0.51
"We treated 5 refractory and complex cases of chromoblastomycosis with 5-aminolevulinic acid photodynamic therapy (ALA-PDT) combined with oral antifungal drugs."( Photodynamic therapy combined with antifungal drugs against chromoblastomycosis and the effect of ALA-PDT on Fonsecaea in vitro.
Chen, X; Hu, Y; Liu, K; Lu, Y; Mao, Z; Qi, X; Sun, H; Wu, Z; Yang, Y; Zhou, X, 2019
)
0.75
"These results provide the basis for the development of a new therapeutic approach, and ALA-PDT combined with oral antifungal drugs constitutes a promising alternative method for the treatment of refractory and complex cases of chromoblastomycosis."( Photodynamic therapy combined with antifungal drugs against chromoblastomycosis and the effect of ALA-PDT on Fonsecaea in vitro.
Chen, X; Hu, Y; Liu, K; Lu, Y; Mao, Z; Qi, X; Sun, H; Wu, Z; Yang, Y; Zhou, X, 2019
)
0.51
" Photodynamic therapy combined with surgery were used in these cases and the results were satisfactory."( Photodynamic therapy combined with dermatosurgical approach for Perifolliculitis Capitis Abscedens et Suffodiens.
Cui, X; Wu, X; Xu, P; Yao, X; Zhu, J; Zhu, W, 2020
)
0.56
"Local ALA-PDT combined with antibiotics could be a safe and effective treatment approach for skin ulcers with sinus tract formation."( Evaluation of ALA-PDT combined with antibiotics for the treatment of skin ulcers with sinus tract formation: A pilot study.
Bai, Y; Chen, J; Cheng, Q; Lei, X; Li, F; Li, J; Tan, Y; Wang, J, 2020
)
0.56
" We reported this case and the successful treatment of photodynamic therapy combined with surgical management."( Photodynamic therapy combined with surgical management of extensive anogenital condylomatosis in a patient with systemic lupus erythematosus.
Dai, SQ; Huang, XW; Jiang, LF; Li, JP; Li, L; Wang, ML; Zeng, K, 2020
)
0.56
"The purpose of this study is to investigate the clinical efficacy of Mohs surgery in combination with topical photodynamic therapy (PDT) for facial basal cell carcinoma."( Clinical efficacy of Mohs surgery combined with topical photodynamic therapy for facial basal cell carcinoma.
Kou, H; Lu, Y; Wang, Y; Yang, Y; Zhang, J; Zhang, X, 2020
)
0.56
"This study described the application of topical ALA-PDT combined with TPF (docetaxel, cisplatin, and 5-fluorouracil) ICT in eleven patients treated due to locally advanced in the oral cavity."( The use of topical ALA-photodynamic therapy combined with induction chemotherapy for locally advanced oral squamous cell carcinoma.
Li, N; Meng, J; Wang, X; Wen, N,
)
0.13
" Then ten patients with surgery experienced radical surgery alone or combined with radiotherapy except a patient with serious heart condition."( The use of topical ALA-photodynamic therapy combined with induction chemotherapy for locally advanced oral squamous cell carcinoma.
Li, N; Meng, J; Wang, X; Wen, N,
)
0.13
" To explore the efficacy and safety of dermabrasion combined with PDT (D-PDT) for the treatment of NMSCs."( Dermabrasion combined with photodynamic therapy: a new option for the treatment of non-melanoma skin cancer.
Bu, W; Chen, M; Chen, X; Fang, F; He, R; Huang, K; Li, F; Luo, X; Su, J; Wei, T; Wu, L; Xie, Y; Yu, J; Yu, N; Zhang, L; Zhang, Q; Zhao, S, 2022
)
0.72
" All DU models were randomly divided into four groups: Untreated group, MSCs group, ALA-PDT group, and ALA-PDT combined with human umbilical cord mesenchymal stem cells (hUC-MSCs) (ALA-PDT + MSCs) group."( Efficacy of the therapy of 5-aminolevulinic acid photodynamic therapy combined with human umbilical cord mesenchymal stem cells on methicillin-resistant Staphylococcus aureus-infected wound in a diabetic mouse model.
Huang, J; Wang, H; Wang, X; Wu, M; Wu, S; Zeng, Q, 2021
)
0.91
"To evaluate the value of Wood's lamp examination combined with 5-aminolevulinic acid (5-ALA) photodynamic therapy (PDT) to determine positive tumor margins in patients with extramammary Paget's disease (EMPD) before surgery."( The application of Wood's lamp combined with 5-aminolevulinic acid for defining tumor margins in patients with extramammary Paget's disease.
Fu, B; Li, J; Lou, Y; Song, C; Zhou, P, 2021
)
1.12
" In the 5-ALA-PDT group, Wood's lamp examination combined with 5-ALA-PDT was used to trace the fluorescence range, and multipoint biopsy was performed according to the pathology to determine the final excision scope."( The application of Wood's lamp combined with 5-aminolevulinic acid for defining tumor margins in patients with extramammary Paget's disease.
Fu, B; Li, J; Lou, Y; Song, C; Zhou, P, 2021
)
0.88
"Wood's lamp examination combined with 5-ALA-PDT may predict tumor margins in EMPD."( The application of Wood's lamp combined with 5-aminolevulinic acid for defining tumor margins in patients with extramammary Paget's disease.
Fu, B; Li, J; Lou, Y; Song, C; Zhou, P, 2021
)
0.88
" Here, we review clinical trial data on the use of photodynamic treatment combined with the sensitizing agent aminolevulinic acid 20% solution (ALA-PDT) for AK management."( Aminolevulinic Acid 20% Solution Combined With Photodynamic Therapy for Treatment of Actinic Keratoses: A Review.
Freeman, S; Gorelick, J, 2021
)
2.28
" This prospective open-label observational single-arm study examined efficacy and safety of simulated daylight (SDL)-PDT using the IndoorLux® system in combination with 5-aminolevulinic acid gel (BF-200 ALA)."( No room for pain: A prospective study showing effective and nearly pain-free treatment of actinic keratosis with simulated daylight photodynamic therapy (SDL-PDT) using the IndoorLux® System in combination with BF-200 ALA (Ameluz®).
Bai-Habelski, JC; Medrano, K; Palacio, A; Reinhold, U, 2022
)
0.92
" The purpose of this study was to illustrate the efficiency and safety of PDD-guided tumor excision combined with ALA-PDT in patients with extramammary Paget's disease (EMPD)."( PDD-guided tumor excision combined with photodynamic therapy in patients with extramammary Paget's disease.
Kou, H; Li, X; Lu, Y; Yang, Y; Zhao, C; Zhu, F, 2022
)
0.72
"In our study, 7 cases of EMPD were treated with PDD-guided tumor excision combined with ALA-PDT."( PDD-guided tumor excision combined with photodynamic therapy in patients with extramammary Paget's disease.
Kou, H; Li, X; Lu, Y; Yang, Y; Zhao, C; Zhu, F, 2022
)
0.72
" The two patients received cryotherapy combined with 5-aminolevulinic acid photodynamic therapy and experienced no relapses during follow-up."( Cryotherapy combined with photodynamic therapy for successful treatment of condyloma acuminatum in special sites such as the nipple and the nasal vestibule: A series of two case reports.
Bu, Z; He, B; Wang, W; Wu, Y; Xiang, T; Yang, Q; Ye, E, 2022
)
0.97
" This study aimed to evaluate the effects of: 1) a high temperature-humidity index (THI) on the developmental competence of bovine oocytes, and 2) 5-ALA administration in combination with sodium ferrous citrate (SFC) during in vitro maturation (IVM) on bovine oocyte developmental competence evaluated at high THI."( 5-Aminolevulinic acid combined with sodium ferrous citrate mitigates effects of heat stress on bovine oocyte developmental competence.
Elgendy, O; Kitahara, G; Osawa, T; Taniguchi, S, 2022
)
1.44
" We investigated the effects of aminolevulinic acid-based photodynamic therapy (ALA-PDT) combined with oral acitretin during therapy of refractory CA in the anal canal."( ALA-PDT combined with oral acitretin in the treatment of refractory condyloma acuminatum in anal canal.
Chen, N; Cheng, Q; Lei, X; Li, J; Tang, H; Wu, J; Zeng, Q; Zhang, L, 2022
)
1
" ALA-PDT group with 51 patients was given ALA-PDT treatment, and ALA-PDT plus acitretin group with 50 patients was given ALA-PDT treatment combined with oral acitretin."( ALA-PDT combined with oral acitretin in the treatment of refractory condyloma acuminatum in anal canal.
Chen, N; Cheng, Q; Lei, X; Li, J; Tang, H; Wu, J; Zeng, Q; Zhang, L, 2022
)
0.72
"ALA-PDT combined with oral acitretin is effective and safe in the treatment of refractory CA in anal canal, and with further study may become an option for these patients."( ALA-PDT combined with oral acitretin in the treatment of refractory condyloma acuminatum in anal canal.
Chen, N; Cheng, Q; Lei, X; Li, J; Tang, H; Wu, J; Zeng, Q; Zhang, L, 2022
)
0.72
" 5-aminolevulinic acid photodynamic therapy (ALA-PDT) can successfully treat urethral CA, however, the experience of using ALA-PDT combined with wart curettage to treat intractable urethral CA is still very limited."( 5-aminolevulinic acid photodynamic therapy combined with wart curettage treatment for intractable urethral condylomata acuminata. A case report.
Chang, R; Jiang, F; Liu, Y; Zhang, C; Zhang, S; Zhang, Y, 2023
)
2.25
"This article explores the effect of 5-aminolevulinic acid (5-ALA)-mediated photodynamic therapy (PDT) combined with cisplatin (CDDP) on the apoptosis of human ovarian cancer cells and the mechanism of action of the combination therapy."( Study on the effect of 5-aminolevulinic acid-mediated photodynamic therapy combined with cisplatin on human ovarian cancer OVCAR-3 ​cells.
Fan, J; Lv, H; Sun, Q; Suo, Y; Wang, Q, 2023
)
1.48
"Human ovarian cancer OVCAR-3 ​cells were cultured in vitro and divided into 5-ALA/PDT group, CDDP group and combined treatment group (5-ALA/PDT combined with different concentrations of CDDP)."( Study on the effect of 5-aminolevulinic acid-mediated photodynamic therapy combined with cisplatin on human ovarian cancer OVCAR-3 ​cells.
Fan, J; Lv, H; Sun, Q; Suo, Y; Wang, Q, 2023
)
1.21
"The CCK-8 assay showed that CDDP in combination with 5-ALA/PDT significantly enhanced cytotoxicity compared to treatment with CDDP alone and that low doses of CDDP were sufficient to induce these combination effects."( Study on the effect of 5-aminolevulinic acid-mediated photodynamic therapy combined with cisplatin on human ovarian cancer OVCAR-3 ​cells.
Fan, J; Lv, H; Sun, Q; Suo, Y; Wang, Q, 2023
)
1.21
"In summary, 5-ALA/PDT combined with CDDP can effectively inhibit cell proliferation and promote apoptosis, and this combination may induce apoptosis by activating the mitochondrial pathway."( Study on the effect of 5-aminolevulinic acid-mediated photodynamic therapy combined with cisplatin on human ovarian cancer OVCAR-3 ​cells.
Fan, J; Lv, H; Sun, Q; Suo, Y; Wang, Q, 2023
)
1.21
" Hence, the study aims to find the effect of laser combined with 5-aminolevulinic acid (ALA) photodynamic therapy for condyloma acuminata in the vulva, vagina, and cervix."( Clinical observation of laser combined with 5-aminolevulinic acid photodynamic therapy for female vulva condyloma acuminatum.
Gao, H; Jama, AA; Lu, Y; Zhao, Z, 2023
)
1.4
" All these patients were treated with laser combined with 5-ALA photodynamic therapy to observe the therapeutic effect."( Clinical observation of laser combined with 5-aminolevulinic acid photodynamic therapy for female vulva condyloma acuminatum.
Gao, H; Jama, AA; Lu, Y; Zhao, Z, 2023
)
1.17
"Laser combined with 5-ALA photodynamic therapy for female vulva, vagina, and cervix condyloma acuminata has a reliable curative effect, low recurrence rate, few adverse reactions, and less pain."( Clinical observation of laser combined with 5-aminolevulinic acid photodynamic therapy for female vulva condyloma acuminatum.
Gao, H; Jama, AA; Lu, Y; Zhao, Z, 2023
)
1.17
" This study aimed to assess the efficacy and dose dependency of ALA combined with iron in sarcopenia by measuring skeletal muscle mass index (SMI)."( Efficacy and Safety of 5-Aminolevulinic Acid Combined with Iron on Skeletal Muscle Mass Index and Physical Performance of Patients with Sarcopenia: A Multicenter, Double-Blinded, Randomized-Controlled Trial (ALADDIN Study).
Abe, Y; Hiyoshi, T; Inoue, I; Kaga, H; Kuribayashi, N; Seino, H; Tamura, Y; Watada, H; Yoshii, H, 2023
)
1.21
"To evaluate the effect of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) combined with CO2 laser pretreatment (Laser+ALA-PDT) on patients with cervical high-grade squamous intraepithelial lesions (HSILs)."( Effect of topical 5-aminolevulinic acid photodynamic therapy versus therapy combined with CO2 laser pretreatment for patients with cervical high-grade squamous intraepithelial lesions.
Feng, C; Gu, L; Hong, Z; Qiu, L; Wang, L; Wei, Y; Wu, D, 2023
)
1.53
"This study investigated the preventive effect of 5-aminolevulinic acid combined with sodium ferrous citrate (5-ALA/SFC) on blood-aqueous barrier (BAB) breakdown induced after anterior chamber paracentesis (ACP) in beagles."( Oral 5-aminolevulinic acid combined with sodium ferrous citrate prevents blood-aqueous barrier breakdown after anterior chamber paracentesis in healthy beagle dogs.
Ichikawa, Y; Kanai, K; Nagai, N; Okada, D; Otaka, Y; Sakai, A; Sangu, R; Tajima, K; Tomatsu, A; Yamashita, Y, 2023
)
1.62

Bioavailability

ExcerptReferenceRelevance
" Based on the lead concentrations found in selected tissues, our results indicate that the bioavailability of phospholipid-bound lead is similar to that of lead acetate at the 300 ppm level."( Comparative effects of feeding lead acetate and phospholipid-bound lead on blood and tissue lead concentrations in young and adult rats.
Alvarez, GH; Ku, Y; Mahaffey, KR, 1978
)
0.26
" The beneficial effects of methionine may be attributed to its ability to increase the bioavailability of glutathione (GSH), useful in chelating Pb and counter-acting the toxic effects, as evidenced by restoration of the Pb-induced decrease in hepatic GSH level by treatment with methionine."( Influence of methionine supplementation in chelation of lead in rats.
Kachru, DN; Khandelwal, S; Tandon, SK, 1989
)
0.28
"In order to clarify the bioavailability of lead in plasma (PbP), we performed a study on five workers in a Japanese factory manufacturing lead glass-based paints."( Correlation between lead in plasma and other indicators of lead exposure among lead-exposed workers.
Hirata, M; Kosaka, H; Miyajima, K; Tabuchi, T; Yoshida, T, 1995
)
0.29
"These studies demonstrate that ALA is stable and poorly absorbed into the systemic circulation during intravesical instillation."( Pharmacokinetics of aminolevulinic acid after intravesical administration to dogs.
Dalton, JT; Golub, AL; Meyer, MC; Mukherjee, A; Tolley, EA; Young, D; Zhou, D, 1999
)
0.63
" Oral bioavailability in these animals averaged 41."( Pharmacokinetics of aminolevulinic acid after oral and intravenous administration in dogs.
Dalton, JT; Golub, AL; Meyer, MC, 1999
)
0.63
" Lipophilicity is one of the key parameters defining the bioavailability of a topically applied drug."( 5-Aminolevulinic acid and its derivatives: physical chemical properties and protoporphyrin IX formation in cultured cells.
Juillerat-Jeanneret, L; Lange, N; Uehlinger, P; van den Bergh, H; Wagnières, G; Zellweger, M, 2000
)
1.03
" Furthermore, calcium-phytate-zinc interactions may adversely affect zinc bioavailability in growing rats."( Effect of calcium supplements to a maize-soya diet on the bioavailability of minerals and trace elements and the accumulation of heavy metals in growing rats.
Most, E; Pallauf, J; Rimbach, G; Walter, A, 2000
)
0.31
" The purpose of these studies was to examine the systemic pharmacokinetics and elimination of ALA, the bioavailability of ALA after oral and intravesical doses, and the factors that affect ALA concentrations in the bladder during intravesical treatment."( Clinical pharmacokinetics of 5-aminolevulinic acid in healthy volunteers and patients at high risk for recurrent bladder cancer.
Dalton, JT; Golub, AL; Marcus, SL; Meyer, MC; Straughn, A; Yates, CR; Yin, D, 2002
)
0.6
" At around 30 degrees C PpIX fluorescence appears later after application of ALA-ester derivatives (14-20 min) than after application of ALA (8 min), indicating differences in their bioavailability (delayed penetration through the stratum corneum, cellular uptake, conversion to ALA, PpIX production) in mouse skin in vivo."( Temperature effect on accumulation of protoporphyrin IX after topical application of 5-aminolevulinic acid and its methylester and hexylester derivatives in normal mouse skin.
Iani, V; Juzenas, P; Juzeniene, A; Kaalhus, O; Moan, J, 2002
)
0.54
" An approach to improve the bioavailability of protoporphyrin IX (PpIX) is the use of ALA derivatives instead of ALA."( Topical application of ALA and ALA hexyl ester on a subcutaneous murine mammary adenocarcinoma: tissue distribution.
Batlle, A; Casas, A; Fukuda, H; Perotti, C; Sacca, P, 2003
)
0.32
" It remains to be seen whether this enhanced local bioavailability of the protoporphyrin prodrug can allow improved photodynamic therapy for the treatment of skin cancer."( Enhanced delivery of 5-aminolevulinic acid esters by iontophoresis in vitro.
Bentley, MV; Delgado-Charro, MB; Guy, RH; Lange, N; Lopez, RF; Salomon, D; van den Bergh, H, 2003
)
0.63
" However, the limited local bioavailability of 5-ALA has widely prevented its use in daily clinical practice."( 5-Aminolevulinic acid derivatives in photomedicine: Characteristics, application and perspectives.
Campo, MA; Fotinos, N; Gurny, R; Lange, N; Popowycz, F,
)
0.85
" Hexaminolevulinate should ideally be confined to the bladder only, but it is likely that some absorption occurs during administration, and therefore the systemic bioavailability is of interest."( Determination of the bioavailability of [14C]-hexaminolevulinate using accelerator mass spectrometry after intravesical administration to human volunteers.
de Vries, DE; Garner, RC; Klem, B; Lappin, G; Nicholson, S; Oosterhuis, B; van de Wetering, J, 2006
)
0.33
"Absolute bioavailability studies in humans are not routinely performed as part of the drug registration process."( The use of isotopes in the determination of absolute bioavailability of drugs in humans.
Garner, RC; Lappin, G; Rowland, M, 2006
)
0.33
" Therefore, lipophilic 5-ALA esters, such as hexylaminolevulinate (HAL), have led to improved local bioavailability and therapeutic efficacy."( Thermosetting gel for the delivery of 5-aminolevulinic acid esters to the cervix.
Collaud, S; Gurny, R; Lange, N; Peng, Q, 2008
)
0.61
"The human proton/oligopeptide cotransporters hPEPT1 and hPEPT2 have been targeted to enhance the bioavailability of drugs and prodrugs."( Molecular mechanism of dipeptide and drug transport by the human renal H+/oligopeptide cotransporter hPEPT2.
Hirayama, BA; Loo, DD; Sala-Rabanal, M; Wright, EM, 2008
)
0.35
" However, in the case of deep, nodular-ulcerative lesions, the complete response rates are lower, possibly related to a lower bioavailability of PpIX."( Comparison of ALA- and ALA hexyl-ester-induced PpIX depth distribution in human skin carcinoma.
Ballini, JP; Dögnitz, N; Gabrecht, T; Lange, N; Salomon, D; van den Bergh, H; Wagnières, G; Zellweger, M, 2008
)
0.35
"The aim was to enhance aminolevulinic acid (ALA) stability by incorporation into low-melting microparticles prepared using a spray congealing procedure and to evaluate temperature-triggered release, allowing topical bioavailability following melting at skin temperature."( Aminolevulinic acid-loaded Witepsol microparticles manufactured using a spray congealing procedure: implications for topical photodynamic therapy.
Al-Kassas, R; Donnelly, RF; McCarron, PA, 2009
)
2.11
" Bioavailability and lipid-mediated enhancement of ALA penetration were determined in excised murine skin."( Aminolevulinic acid-loaded Witepsol microparticles manufactured using a spray congealing procedure: implications for topical photodynamic therapy.
Al-Kassas, R; Donnelly, RF; McCarron, PA, 2009
)
1.8
" However, due to ALA's high polarity its dermal bioavailability is rather limited and thus, permeation enhancement of this active is of major interest in research."( Rheological characterization and permeation behavior of poloxamer 407-based systems containing 5-aminolevulinic acid for potential application in photodynamic therapy.
Müller-Goymann, CC; van Hemelrijck, C, 2012
)
0.6
" However, the bioavailability of ALA is limited by its hydrophilic properties and limited cell uptake."( The use of dipeptide derivatives of 5-aminolaevulinic acid promotes their entry to tumor cells and improves tumor selectivity of photodynamic therapy.
Batlle, A; Casas, A; Di Venosa, G; Eggleston, IM; Giuntini, F; Juarranz, A; MacRobert, AJ; Mamone, L; Vallecorsa, P; Vanzuli, S, 2015
)
0.42
" The main disadvantage of this therapy is that ALA is poorly absorbed by cells due to its high hydrophilicity."( Design, synthesis and biological evaluation of 5-aminolaevulinic acid/3-hydroxypyridinone conjugates as potential photodynamic therapeutical agents.
Battah, S; Hider, RC; Kong, X; Reeder, BJ; Zhou, T; Zhu, CF, 2015
)
0.42
" These results lead to consider the developed formulations potentially useful for improving ALA bioavailability and therapeutic effectiveness in skin malignancies treatment by topical PDT."( Development and ex vivo evaluation of 5-aminolevulinic acid-loaded niosomal formulations for topical photodynamic therapy.
Bragagni, M; Mastrolorenzo, A; Mura, P; Scozzafava, A; Supuran, CT, 2015
)
0.68
" eEF1A1 was found to enrich ALA-induced PpIX in cells by competitively blocking the downstream bioavailability of PpIX."( eEF1A1 binds and enriches protoporphyrin IX in cancer cells in 5-aminolevulinic acid based photodynamic therapy.
Cui, X; Fan, Z; He, H; Li, B; Liu, W; Wei, D; Wei, X; Ye, H; Zhu, N, 2016
)
0.67
" However, the effectiveness of ALA-PDT is limited by the relatively poor bioavailability of ALA and rapid conversion of PpIX to haem."( Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
Battah, S; Dobbin, PS; Hider, RC; MacRobert, AJ; Zhou, T, 2017
)
0.46
" However, chemical instability, low bioavailability and poor pharmacokinetic profile limit systemic efficacy of 5-ALA."( Activity of phosphatase-sensitive 5-aminolevulinic acid prodrugs in cancer cell lines.
Allémann, E; Babič, A; Herceg, V; Lange, N, 2017
)
0.73
"The development of nanocarriers is an important approach to increase the bioavailability of hydrophilic drugs in target cells."( In vitro assessment of anti-tumorigenic mechanisms and efficacy of NanoALA, a nanoformulation of aminolevulic acid designed for photodynamic therapy of cancer.
da Silva, JR; de Andrade, LR; Lacava, ZGM; Primo, FL; Tedesco, AC, 2017
)
0.46
" However, the major obstacle with a majority of photosensitizers is its limited bioavailability and long-term photosensitivity which limits its use."( Role of nanocarriers in photodynamic therapy.
Ali, J; Baboota, S; Kotta, S; Nabi, B; Narang, JK; Qidwai, A, 2020
)
0.56
" The 5-ALA skin permeation is considerably reduced due to its hydrophilic characteristics, decreasing its local bioavailability and therapeutic effect."( PLGA-PVA-PEG Single Emulsion Method as a Candidate for Aminolevulinic Acid (5-ALA) Encapsulation: Laboratory Scaling Up and Stability Evaluation.
Bagnato, VS; da Silva, GR; Dos Santos, AL; Dos Santos, MC; Dos Santos, SC; Inada, NM; Rodrigues de Lima, V; Sanches, EA; Soares, AC; Ţălu, Ş, 2022
)
0.97
" In AIP mice, preventive treatment with an experimental fusion protein of insulin and apolipoprotein A-I improved the disease by promoting fat mobilization in adipose tissue, increasing the metabolite bioavailability for the TCA cycle and inducing mitochondrial biogenesis in the liver."( Understanding Carbohydrate Metabolism and Insulin Resistance in Acute Intermittent Porphyria.
Córdoba, KM; Ena, J; Enríquez de Salamanca, R; Fontanellas, A; Jericó, D; Morales-Conejo, M; Solares, I, 2022
)
0.72

Dosage Studied

Photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA) is increasingly employed for skin cancer, yet ALA dosing is crude. Dose-response studies were conducted for 100 to 400 mg/ml 5 mg/kg.

ExcerptRelevanceReference
" The dose-response curves obtained for both these effects closely mirror the accumulation in the liver of a compound that is labelled by 5-amino[14C]laevulinate and is unextractable by acetone/HCl."( Formation of cobalt protoporphyrin in the liver of rats. A mechanism for the inhibition of liver haem biosynthesis by inorganic cobalt.
de Matteis, F; Gibbs, AH; Sinclair, JF; Sinclair, P, 1979
)
0.26
"In this study dose-response and dose-effect relationships were examined with reference to no-effect levels using observed data from three groups of lead workers who had been exposed to three different concentrations of lead."( [Dose-response relationships at different exposure levels. Re-examination in establishing no-effect levels (author's transl)].
Sakurai, H; Sugita, M; Tsuchiya, K, 1978
)
0.26
"Lead absorption and prevention of the serious effects of lead re-examined from the viewpoints of the critical organ and clinical effect concepts and the associated dose-effect and dose-response relationships."( Dose-effect and dose-response relationships for lead in children.
Barrett, MB; Chisolm, JJ; Mellits, ED, 1975
)
0.25
" After treatment with Resochin in an erroneously high dosage (1."( [Accident in treatment of porphyria cutanea tarda by chloroquine (Resochin) (author's transl)].
Eichenauer, MG; Goerz, G; Krieg, T, 1976
)
0.26
" at the dosage of 600-1200 mg for a variable period of 3-5 days in the first group, for 7-10 days in the patients with PCT."( [Evaluation of the effects of reduced glutathione in subjects with acquired and congenital changes in heme biosynthesis].
Alessio, L; Buizza, P; De Panfilis, G; De Vincentiis, A; Ferioli, A; Leali, C; Pasolini, G, 1992
)
0.28
"9%), the vehicle, and 50, 200 or 800/400 mg/kg/d (the highest dosage had to be lowered after the first week due to acute drug intolerance)."( Chronic intravenous toxicity of the new antibiotic cefpirome in monkeys.
Engelbart, K; Horstmann, G, 1990
)
0.28
" Adjustments in dosage or route of administration were sometimes needed."( A gonadotropin releasing hormone analogue prevents cyclical attacks of porphyria.
Anderson, KE; Bardin, CW; Kappas, A; Spitz, IM, 1990
)
0.28
" These findings suggest that the amount of protoporphyrin IX accumulation from ALA reflects the extent of deficiency of ferrochelatase and is proportional to the dosage of abnormal EPP gene in cultured fibroblasts."( Accumulation of protoporphyrin IX from delta-aminolevulinic acid in bovine skin fibroblasts with hereditary erythropoietic protoporphyria. A gene-dosage effect.
Ruth, G; Sassa, S; Schwartz, S, 1981
)
0.52
" The dose-response relationship between PbB and ALAU suggested that a PbB below 50-60 micrograms/dl is a proper practical limit of biological monitoring for lead workers."( Occupational lead exposure of storage battery workers in Korea.
Lee, BK, 1982
)
0.26
"A dose-response relationship between exposure to lead and delta-aminolaevulinic acid concentration in urine (ALA-U), and between blood lead (Pb-B) and zinc protoporphyrin IX (ZPP-B) concentrations in blood were examined in 90 male workers exposed to lead."( [Selected biomarkers for evaluating occupational exposure to lead among workers from the "Miasteczko Slaskie" zincworks in Tarnowskie Gory].
Komosińska, K; Kraśnicka, A; Kwapuliński, J; Orczyk, H; Wiechuła, D, 1995
)
0.29
" Dose-response studies were conducted for 100 to 400 mg/ml 5-aminolevulinic acid."( Photodynamic destruction of endometrial tissue with topical 5-aminolevulinic acid in rats and rabbits.
Berns, MW; Krasieva, T; Schell, M; Tadir, Y; Tromberg, BJ; Wyss, MT; Wyss, P, 1994
)
0.77
" For groups 2 and 6, atracurium was administered at a dosage of 4 mg/kg of body weight, followed by a continuous infusion of 15 mg/kg/h."( Porphyrinogenic effects of atracurium, vecuronium, and pancuronium in a primed rat model.
Bach, A; Böhrer, H; Bolsen, K; Goerz, G; Kohl, B; Martin, E; Schmidt, H, 1994
)
0.29
" The intensity of fluorescence varied with the dosage and route of administration of 5-aminolevulinic acid."( Fluorescence and photosensitization of experimental endometriosis in the rat after systemic 5-aminolevulinic acid administration: a potential new approach to the diagnosis and treatment of endometriosis.
Kennedy, JC; Reid, RL; Van Dijk-Smith, JP; Van Vugt, DA; Yang, JZ, 1996
)
0.74
"Photodynamic therapy (PDT) with topical 5-aminolevulinic acid (ALA) is increasingly employed for skin cancer, yet ALA dosing is crude."( Iontophoretic delivery of ALA provides a quantitative model for ALA pharmacokinetics and PpIX phototoxicity in human skin.
Anderson, RR; Kollias, N; Rhodes, LE; Tsoukas, MM, 1997
)
0.56
"To determine the in vivo dose-response relation between administered 5-aminolevulinic acid (ALA) and the concentration of protoporphyrin IX (PpIX) produced in rat uterine tissue, to determine the effect of estrogen on ALA-induced PpIX production in the rat endometrium and myometrium, and to determine the selectivity of ALA-induced PpIX production in uterine tissue."( Effect of 5-aminolevulinic acid dose and estrogen on protoporphyrin IX concentrations in the rat uterus.
Pottier, RH; Reid, RL; Roy, BN; Van Vugt, DA; Weagle, GE,
)
0.74
"An in vivo dose-response relation was demonstrated between ALA and uterine production of PpIX, with maximum PpIX concentrations occurring after 25 mg of intrauterine ALA."( Effect of 5-aminolevulinic acid dose and estrogen on protoporphyrin IX concentrations in the rat uterus.
Pottier, RH; Reid, RL; Roy, BN; Van Vugt, DA; Weagle, GE,
)
0.51
" This study compares bolus with fractionated ALA dosing in order to determine whether one of these methods results in a higher tissue concentration of PP."( Effects of fractionated 5-aminolevulinic acid administration on tissue levels of protoporphyrin in vivo.
Fromm, D; Herman, MA; Kessel, D; Luo, Y; Patacsil, V; Webber, J, 1997
)
0.6
" A dose-response relationship was observed between 10 and 25 mg of ALA and endometrial PpIX concentrations."( Effect of continuous and multiple doses of 5-aminolevulinic acid on protoporphyrin IX concentrations in the rat uterus.
Pottier, RH; Reid, RL; Roy, BN; Van Vugt, DA; Weagle, GE, 1997
)
0.56
" In our in vivo/in vitro model system we have shown that pre-treatment with ADM increased the cytotoxicity of ALA-PDT at a dosage level of ADM which did not raise LPO levels in heart tissue."( Enhancement of aminolevulinic acid based photodynamic therapy by adriamycin.
Casas, A; del C Batlle, AM; Fukuda, H; Riley, P, 1997
)
0.65
" Both Ps induced a light dose-dependent impairment of the mitochondrial function with the dose-response curve being steep for ALA and flat for Ph."( Ultrastructural changes in PAM cells after photodynamic treatment with delta-aminolevulinic acid-induced porphyrins or photosan.
Hönigsmann, H; Ortel, B; Radakovic-Fijan, S; Rappersberger, K; Tanew, A, 1999
)
0.53
" These results demonstrated that low pH ALA aqueous solution may be one possible dosage form to be considered for market introduction."( Degradation mechanism and stability of 5-aminolevulinic acid.
Bunke, A; Burmeister, G; Gander, B; Merkle, HP; Schmid, H; Zerbe, O, 2000
)
0.57
" The different parameters involved in this photodynamic effect are reported, namely delta-ala concentration and loading time, light dosage and the influence of intracellular and medium-excreted porphyrins."( Photodynamic DNA damage mediated by delta-aminolevulinic acid-induced porphyrins.
Dubois, J; Duez, P; Hanocq, M, 2001
)
0.57
" It allows quasiquantitative testing of different protoporphyrin IX precursors with respect to dose-response curves and pharmacokinetics, as well as the evaluation of different incubation conditions and/or different drug formulations."( Routine experimental system for defining conditions used in photodynamic therapy and fluorescence photodetection of (non-) neoplastic epithelia.
Etter, AL; Gerber, P; Jichlinski, P; Kucera, P; Lange, N; Marti, A; van Den Bergh, H; Vaucher, L, 2001
)
0.31
" Iron dose-response curves in ALA- and PCB126-treated Cyp1a2(+/+) mice showed that hepatic iron levels greater than 850 microg/g liver were required to produce significant uroporphyrin accumulation in the liver."( Uroporphyria in mice: thresholds for hepatic CYP1A2 and iron.
Bement, WJ; Dalton, TP; Eisenstein, RS; Gerhard, GS; Gorman, N; Nebert, DW; Ross, KL; Sinclair, JF; Sinclair, PR; Szakacs, JG; Walton, HS, 2002
)
0.31
" Although different formulations containing variable amounts of ALA have been applied in PDT, the dose-response relationships between transdermal ALA delivery and cutaneous protoporphyrin IX (PpIX) accumulation have not been studied."( In vitro/in vivo correlations between transdermal delivery of 5-aminolaevulinic acid and cutaneous protoporphyrin IX accumulation and effect of formulation.
Chen, IH; Lo, YL; Tsai, JC; Wong, TW, 2002
)
0.31
"Knowledge of the dose-response relationships and the effect of formulation is important for designing optimal formulations and treatment schedules for topical ALA-PDT."( In vitro/in vivo correlations between transdermal delivery of 5-aminolaevulinic acid and cutaneous protoporphyrin IX accumulation and effect of formulation.
Chen, IH; Lo, YL; Tsai, JC; Wong, TW, 2002
)
0.31
"It will be the aim of further investigations to verify the optimal time of incubation and dosing of systemical 5-ALA application to enhance fluorescence contrasts and set the basis for fluorescence guided resections."( [Fluorescence staining of oral and laryngeal cancer after application of 5-aminolevulinic acid].
Baumgartner, R; Betz, CS; Heinrich, P; Janda, P; Leunig, A, 2002
)
0.54
" The aim of this study was to establish the optimum dosage regime for ALA-PDT for Barrett's esophagus."( Comparison of high- vs low-dose 5-aminolevulinic acid for photodynamic therapy of Barrett's esophagus.
Ackroyd, R; Brown, NJ; Brown, SB; Kelty, CJ; Reed, MW, 2004
)
0.6
" There was no significant difference in response between dosing 4 or 6 h prior to PDT."( Comparison of high- vs low-dose 5-aminolevulinic acid for photodynamic therapy of Barrett's esophagus.
Ackroyd, R; Brown, NJ; Brown, SB; Kelty, CJ; Reed, MW, 2004
)
0.6
" PY extraction from semi-solid devices approached 100% efficiency demonstrating that the reported assay is suitable for evaluating stability of novel dosage forms intended for ALA delivery."( Analysis of pyrazine 2,5-dipropionic acid in 5-aminolevulinic acid-loaded urological and topical delivery vehicles: methodology and assay validation.
Andrews, GP; Donnelly, RF; McCarron, PA; Woolfson, AD, 2005
)
0.59
" For laser treatments, a sigmoidal light dose-response relationship predicted more than 85% initial response rates for light doses 150 J/cm(2) or more."( Treatment of diffuse basal cell carcinomas and basaloid follicular hamartomas in nevoid basal cell carcinoma syndrome by wide-area 5-aminolevulinic acid photodynamic therapy.
Bellnier, DA; Blumenson, LE; Cheney, R; Frawley, NP; Oseroff, AR; Pivnick, EK; Shieh, S, 2005
)
0.53
" This perturbation can be easily spotted using the rapid method of dosing the delta-aminolevulinic acid in urine (ALA)."( [Delta-aminolevulinic acid measurement in people professionally exposed to lead].
Agoroaei, L; Alexandrescu, L; Butnaru, C; Butnaru, E; Cotae, N; Mircea, C; Proca, M,
)
0.81
"The dosage of 20 mg/kg body weight of 5-ALA is feasible for fluorescence diagnosis of nonpigmented endometriosis."( Detection of nonpigmented endometriotic lesions with 5-aminolevulinic acid-induced fluorescence.
Buchweitz, O; Kiesel, L; Staebler, A; Wülfing, P, 2004
)
0.57
" This approach makes ALA dosing difficult and delivery to demanding areas, such as the vulval, perineal and perianal skin, are seldom possible."( Design and evaluation of a water-soluble bioadhesive patch formulation for cutaneous delivery of 5-aminolevulinic acid to superficial neoplastic lesions.
Donnelly, RF; McCarron, PA; Woolfson, AD; Zawislak, A, 2006
)
0.55
"IPL and PDL demonstrated a faint dose-response effect on PDT activation, but were less potent than a smaller fluence of CW blue light."( Do pulsed lasers produce an effective photodynamic therapy response?
Grande, DJ; Strasswimmer, J, 2006
)
0.33
" In 13 healthy volunteers, we assessed the time course and dose-response of the acute cutaneous response(s) to ALA-PDT, the impact of H(1) antihistamine blockade, and measured dermal histamine release."( Histamine is released following aminolevulinic acid-photodynamic therapy of human skin and mediates an aminolevulinic acid dose-related immediate inflammatory response.
Brooke, RC; Church, MK; Clough, GF; Friedmann, PS; Rhodes, LE; Sidhu, MK; Sinha, A; Watson, RE, 2006
)
0.62
" The proportion of dead cells increased with increases in the dosage of light."( Massive apoptotic cell death of human glioma cells via a mitochondrial pathway following 5-aminolevulinic acid-mediated photodynamic therapy.
Inoue, H; Kajimoto, Y; Kuroiwa, T; Miyatake, S; Miyoshi, N; Ogawa, N; Otsuki, Y; Shibata, MA, 2007
)
0.56
" Results suggest that this simple formulation containing ALA can be administered directly to the colorectal area and is a feasible alternative to peroral dosing of ALA."( Formulation and characterization of poly(ethylene glycol)-based, 5-aminolevulinic acid-loaded solid-dosage forms intended for photodynamic and photodiagnostic methodologies in the colorectal region.
Andrews, GP; Donnelly, RF; McCarron, PA; Morrow, DI; Woolfson, AD, 2007
)
0.58
" At both 1 and 4 hours after 5-ALA injection, the net mean intensity of parathyroid gland fluorescence was optimal at the highest dose (700 mg/kg) and positively correlated with dosage increases."( Fluorescent detection of rat parathyroid glands via 5-aminolevulinic acid.
Asher, SA; Newman, JR; Pehler, SF; Peters, GE; Rosenthal, EL; Zinn, K, 2008
)
0.59
" Metronomic dosing in PDT is proposed by analogy and the rationale is as a means to improve the tumor-specific response through cell death by apoptosis."( Metronomic PDT and cell death pathways.
Alqawi, O; Espiritu, M; Singh, G, 2010
)
0.36
" A novel dosing approach was introduced in that we used a photobleaching percentage instead of a preset fluence."( Fractionated illumination at low fluence rate photodynamic therapy in mice.
De Bruijn, HS; De Haas, ER; Middelburg, TA; Neumann, HA; Robinson, DJ; Sterenborg, HJ; Van Der Ploeg-van den Heuvel, A; Van Zaane, F,
)
0.13
" Ten Sprague-Dawley (S-D) adult rats were injected intraperitoneally with a 300 mg/kg dosage of 5-ALA."( Fluorescence identification of parathyroid glands by aminolevulinic acid hydrochloride in rats.
Guo, ZM; Li, CQ; Li, H; Liu, WW; Yang, AK; Zhang, Q, 2011
)
0.62
"To determine the effect of ALA-PDT on fibroblast cells from hypertrophic scars in vitro, and to identify proper dosage of photosensitizer and energy level of laser light."( [Influence of ALA-PDT on fibroblast cells from hypertrophic scars].
Luo, LD; Pan, L; Wang, L; Zhong, JB, 2011
)
0.37
" The expression of PCNA in fibroblast cells was detected after cultured with ALA-PDT, which was selected according to the proper dosage of ALA and laser light from the result of CCK-8."( [Influence of ALA-PDT on fibroblast cells from hypertrophic scars].
Luo, LD; Pan, L; Wang, L; Zhong, JB, 2011
)
0.37
" The inhibition effect appeared when ALA and PDT applied simultaneously, and the inhibition rate increased with the dosage of photosensitizer and the energy level of laser light."( [Influence of ALA-PDT on fibroblast cells from hypertrophic scars].
Luo, LD; Pan, L; Wang, L; Zhong, JB, 2011
)
0.37
"The inhibition effect of ALA-PDT on fibroblast cells from hypertrophic scars increases with the dosage of photosensitizer and the energy level of He-Ne laser light."( [Influence of ALA-PDT on fibroblast cells from hypertrophic scars].
Luo, LD; Pan, L; Wang, L; Zhong, JB, 2011
)
0.37
" Each lesion was irradiated once a week for 3 weeks, for a total dosage of 300 J/cm(2) (100 mW/cm(2))."( Comparison of the efficacy of ALA-PDT using an excimer-dye laser (630 nm) and a metal-halide lamp (600 to 740 nm) for treatment of Bowen's disease.
Akita, Y; Kimura, M; Kinoshita, Y; Matsumoto, Y; Mizutani, K; Nakano, A; Tamada, Y; Tanaka, T; Watanabe, D; Yanagishita, T, 2012
)
0.38
" Application of ALA at lower dosage (2 mg/l) enhanced the seedling growth and biomass."( 5-Aminolevulinic acid ameliorates cadmium-induced morphological, biochemical, and ultrastructural changes in seedlings of oilseed rape.
Ali, B; Ali, S; Daud, MK; Geng, XX; Huang, CR; Liu, HB; Qi, ZY; Zhou, WJ, 2013
)
1.11
" A dose-response between Pb levels and plasma viscosity was not observed."( The effect of occupational lead exposure on lipid peroxidation, protein carbonylation, and plasma viscosity.
Birkner, E; Kasperczyk, A; Kasperczyk, S; Słowińska-Łożyńska, L; Wielkoszyński, T, 2015
)
0.42
" The participant numbers with impaired glucose tolerance and impaired fasting glucose decreased in the highest dosage group of ALA-P plus iron compared with the placebo group."( 5-aminolevulinic acid, a precursor of heme, reduces both fasting and postprandial glucose levels in mildly hyperglycemic subjects.
Awaya, T; Higashikawa, F; Noda, M; Sugiyama, M; Tanaka, T,
)
0.85
" PDT involves dosing patients with photosensitizing drugs, and then exposing them to light using a directed energy device in order to manifest a therapeutic effect."( Photodynamic therapy: occupational hazards and preventative recommendations for clinical administration by healthcare providers.
Breskey, JD; Colvard, MD; Lacey, SE; Paradise, WA; Radosevich, JA; Vesper, BJ, 2013
)
0.39
" The entire screening assay takes only 1 hour, and the collected PDT outcomes (cell viability) for combinatorial screening are analysed and reported as traditional dose-response curves or 3D bubble charts using custom software."( A high-throughput photodynamic therapy screening platform with on-chip control of multiple microenvironmental factors.
Kim, G; Kopelman, R; Lee, YE; Lou, X; Yoon, E; Yoon, HK, 2014
)
0.4
"Efficacy of 5-ALA PDT could be increased by adjunction of ciprofloxacin in conventional clinical dosing and by prolongation of ALA incubation time."( Enhancing the effect of 5-aminolevulinic acid based photodynamic therapy in human meningioma cells.
Cornelius, JF; El Khatib, M; Giannakis, A; Senger, B; Slotty, PJ; Steiger, HJ, 2014
)
0.7
"With a prospective feasibility study, we aimed to analyse the effect of different time points for application and dosage of preoperative oral 5-aminolevulinic acid administration for photodynamic diagnosis of peritoneal metastases in ovarian cancer patients."( Photodynamic diagnosis with 5-aminolevulinic acid for intraoperative detection of peritoneal metastases of ovarian cancer: A feasibility and dose finding study.
Hillemanns, P; Klapdor, R; Reif, J; Stepp, H; Wimberger, P, 2017
)
0.94
" 5-Aminolevulinic acid was orally administered 3-14 hours before surgery using a dosage of 1 mg/kg, 4-9 hours using 10 mg/kg, and 9-16 hours using 10 mg/kg, respectively."( Photodynamic diagnosis with 5-aminolevulinic acid for intraoperative detection of peritoneal metastases of ovarian cancer: A feasibility and dose finding study.
Hillemanns, P; Klapdor, R; Reif, J; Stepp, H; Wimberger, P, 2017
)
1.36
" Orally applied 5-aminolevulinic acid with a dosage of 1 mg/kg revealed no detectable fluorescence."( Photodynamic diagnosis with 5-aminolevulinic acid for intraoperative detection of peritoneal metastases of ovarian cancer: A feasibility and dose finding study.
Hillemanns, P; Klapdor, R; Reif, J; Stepp, H; Wimberger, P, 2017
)
1.08
" 5-Aminolevulinic acid should be used at a dosage of at least 10 mg/kg 4-9 hours preoperatively."( Photodynamic diagnosis with 5-aminolevulinic acid for intraoperative detection of peritoneal metastases of ovarian cancer: A feasibility and dose finding study.
Hillemanns, P; Klapdor, R; Reif, J; Stepp, H; Wimberger, P, 2017
)
1.36
" They revealed a different fluorescence kinetics and dose-response curves for the different types of 5-ALA prodrugs."( Activity of phosphatase-sensitive 5-aminolevulinic acid prodrugs in cancer cell lines.
Allémann, E; Babič, A; Herceg, V; Lange, N, 2017
)
0.73
"To study the effective therapeutic concentration, drug application duration, irradiation duration and irradiation dosage of 5-aminolevulinic acid photodynamic therapy (ALA-PDT) for treating vitiligo and observe its clinical efficacy."( A case series pilot study on the combination of 5-aminolevulinic acid and photodynamic therapy (ALA-PDT) for treatment of vitiligo.
Guo, X; Lin, H; Zhang, Y; Zou, X,
)
0.59
"ALA with different drug concentrations, drug application durations, irradiation durations and irradiation dosages were adopted to treat skin lesions caused by vitiligo to determine the effective drug concentration, drug application duration, irradiation duration and irradiation dosage for treating three vitiligo volunteers and observe the therapeutic results."( A case series pilot study on the combination of 5-aminolevulinic acid and photodynamic therapy (ALA-PDT) for treatment of vitiligo.
Guo, X; Lin, H; Zhang, Y; Zou, X,
)
0.38
"5%, drug application duration for 3 hours, irradiation dosage of 80mw/cm2 and irradiation duration for 20 min was effective in treating vitiligo."( A case series pilot study on the combination of 5-aminolevulinic acid and photodynamic therapy (ALA-PDT) for treatment of vitiligo.
Guo, X; Lin, H; Zhang, Y; Zou, X,
)
0.38
"5%, drug application duration for 3 hours, irradiation dosage of 80 mw/cm2 and irradiation duration for 20 min is effective in treating vitiligo."( A case series pilot study on the combination of 5-aminolevulinic acid and photodynamic therapy (ALA-PDT) for treatment of vitiligo.
Guo, X; Lin, H; Zhang, Y; Zou, X,
)
0.38
" In cell culture, we show that the overall dose-response is consistent with established light sources and complete cell death of ALA photosensitized cells can be achieved in the irradiated zone."( Development and evaluation of a low-cost, portable, LED-based device for PDT treatment of early-stage oral cancer in resource-limited settings.
Celli, JP; Cuckov, F; Daly, L; Hasan, T; Khan, AP; Liu, H; Liu, Y; Mallidi, S; Rudd, G, 2019
)
0.51
" 5-ALA was orally administered 3 hours before induction of anesthesia at a dosage of 20 mg/kg, whereas fluorescein was intravenously administered at induction of anesthesia at a dosage of 4 mg/kg."( Combined Fluorescence Using 5-Aminolevulinic Acid and Fluorescein Sodium at Glioblastoma Border: Intraoperative Findings and Histopathologic Data About 3 Newly Diagnosed Consecutive Cases.
Della Puppa, A; Gardiman, MP; Munari, M; Volpin, F, 2019
)
0.8
" Finally, a theoretical hemin effect was implemented to illustrate the applicability of the model to dosage optimization in drug therapies."( Computational disease model of phenobarbital-induced acute attacks in an acute intermittent porphyria mouse model.
Fontanellas, A; Jericó, D; Parra-Guillén, ZP; Sampedro, A; Serrano-Mendioroz, I; Trocóniz, IF; Vera-Yunca, D, 2019
)
0.51
" Herein, we performed animal and human studies to investigate whether 5-ALA dosed glioma cells, in vitro and in vivo, release PpIX positive EVs in circulation which can be captured and analyzed."( Characterization of plasma-derived protoporphyrin-IX-positive extracellular vesicles following 5-ALA use in patients with malignant glioma.
Ayinon, C; Balaj, L; Carter, BS; Charest, A; Delcuze, B; Ghiran, I; Hochberg, FH; Jones, PS; Lansbury, E; Mordecai, S; Small, JL; Tigges, J; Yekula, A, 2019
)
0.51
" Greater and more sustained reductions in ALA and PBG were achieved with once monthly dosing compared with once quarterly dosing."( Pharmacokinetics and Pharmacodynamics of the Small Interfering Ribonucleic Acid, Givosiran, in Patients With Acute Hepatic Porphyria.
Agarwal, S; Clausen, VA; Goel, V; Habtemariam, BA; Kim, JB; Robbie, GJ; Simon, AR, 2020
)
0.56
"63 mg/kg dry materials, exceeding the usual effective dosage reported in animal trials, was achieved within 48 h through SSF of 20 kg feed in a 90-L steel drum."( Efficient solid-state fermentation for the production of 5-aminolevulinic acid enriched feed using recombinant Saccharomyces cerevisiae.
Chen, T; Chen, Z; Jin, B; Lu, L; Ma, H; Mao, Y; Pan, Y, 2020
)
0.8
" Clinical trials of 5-ALA RDT for HGG are needed to evaluate the optimum timing, dosing and effectiveness."( 5-Aminolevulinic acid radiodynamic therapy for treatment of high-grade gliomas: A systematic review.
Michael, AP; Nordmann, NJ, 2021
)
1.34
" No difference was found when comparing the fluorescence between primary grade I and II meningiomas after any 5-ALA dosage (p > ."( 5-ALA kinetics in meningiomas: analysis of tumor fluorescence and PpIX metabolism in vitro and comparative analyses with high-grade gliomas.
Brokinkel, B; Bunk, EC; Senner, V; Stummer, W; Wagner, A, 2021
)
0.62
"A significant dose-response relationship was observed between Pb-B and ALA-U based on Pb-B-classified observations of increases in ALA-U values and the prevalence of over-reference ALA-U as well as regression analyses independent of smoking habits."( Reassessment of the threshold of the blood lead level to increase urinary δ-aminolevulinic acid based on their relationship in recent lead workers in Japan.
Horiguchi, H; Ono, A, 2021
)
0.85
" The final model was used to assess the adequacy of the recommended givosiran dosing regimen across demographic and clinical subgroups."( Pharmacokinetic-pharmacodynamic model of urinary δ-aminolevulinic acid reduction after givosiran treatment in patients with acute hepatic porphyria.
Lee, J; Melch, M; Robbie, GJ, 2023
)
1.16
" We measured GICs-5-ALA uptake and PDT/5-ALA activity in dose-response curves and the efficacy of the treatment by measuring proliferative activity and apoptosis."( Preclinical Studies with Glioblastoma Brain Organoid Co-Cultures Show Efficient 5-ALA Photodynamic Therapy.
Aldecoa, I; Bedia, C; Centellas, M; Diao, D; Ferrés, A; González Sánchez, JJ; Martínez-Soler, F; Mosteiro, A; Muñoz-Tudurí, M; Pedrosa, L; Pineda, E; Sevilla, A; Sierra, À; Stanzani, E; Tortosa, A, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (9)

RoleDescription
photosensitizing agentA chemical compound that can be excited by light of a specific wavelength and subsequently transfer energy to a chosen reactant. This is commonly molecular oxygen within a cancer tissue, which is converted to (highly rective) singlet state oxygen. This rapidly reacts with any nearby biomolecules, ultimately killing the cancer cells.
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
dermatologic drugA drug used to treat or prevent skin disorders or for the routine care of skin.
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
plant metaboliteAny eukaryotic metabolite produced during a metabolic reaction in plants, the kingdom that include flowering plants, conifers and other gymnosperms.
human metaboliteAny mammalian metabolite produced during a metabolic reaction in humans (Homo sapiens).
Saccharomyces cerevisiae metaboliteAny fungal metabolite produced during a metabolic reaction in Baker's yeast (Saccharomyces cerevisiae).
Escherichia coli metaboliteAny bacterial metabolite produced during a metabolic reaction in Escherichia coli.
mouse metaboliteAny mammalian metabolite produced during a metabolic reaction in a mouse (Mus musculus).
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
delta-amino acidA non-proteinogenic amino acid in which the amino group is located on the carbon atom at the position delta to the carboxy group.
4-oxo monocarboxylic acid
amino acid zwitterionThe zwitterionic form of an amino acid having a negatively charged carboxyl group and a positively charged amino group.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (17)

PathwayProteinsCompounds
Glycine and Serine Metabolism2452
Porphyrin Metabolism1636
Acute Intermittent Porphyria1636
Porphyria Variegata (PV)1636
Congenital Erythropoietic Porphyria (CEP) or Gunther Disease1636
Dimethylglycine Dehydrogenase Deficiency2452
Dihydropyrimidine Dehydrogenase Deficiency (DHPD)2452
Sarcosinemia2452
Non-Ketotic Hyperglycinemia2452
Hereditary Coproporphyria (HCP)1636
Hyperglycinemia, Non-Ketotic2452
3-Phosphoglycerate Dehydrogenase Deficiency2452
Glycine and Serine metabolism ( Glycine and Serine metabolism )3649
Porphyrin_metabolism ( Porphyrin metabolism )716
Hemesynthesis defects and porphyrias018
Biochemical pathways: part I0466
Tyrosine metabolism and related disorders724

Protein Targets (12)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, Beta-lactamaseEscherichia coli K-12Potency22.38720.044717.8581100.0000AID485294
bromodomain adjacent to zinc finger domain 2BHomo sapiens (human)Potency0.70790.707936.904389.1251AID504333
gemininHomo sapiens (human)Potency0.12590.004611.374133.4983AID624297
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Gamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)IC50 (µMol)12.90002.22002.22002.2200AID406571
Glutamate receptor 1Homo sapiens (human)Ki790.00000.01472.50379.2000AID92023
Glutamate receptor 2Homo sapiens (human)Ki790.00000.01681.27725.0000AID92023
Glutamate receptor 3Homo sapiens (human)Ki790.00000.02060.53222.2000AID92023
Glutamate receptor ionotropic, kainate 3Rattus norvegicus (Norway rat)Ki790.00000.00380.79754.1000AID92023
Solute carrier family 15 member 1Homo sapiens (human)Ki790.00000.18003.39339.8000AID92023
Glutamate receptor 4Homo sapiens (human)Ki790.00000.04001.23358.8500AID92023
Solute carrier family 15 member 2Rattus norvegicus (Norway rat)Ki230.00003.00006.47788.5000AID681124
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (48)

Processvia Protein(s)Taxonomy
gamma-aminobutyric acid signaling pathwayGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
chemical synaptic transmissionGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
modulation of chemical synaptic transmissionGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
regulation of presynaptic membrane potentialGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
regulation of membrane potentialGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
chloride transmembrane transportGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
regulation of receptor recyclingGlutamate receptor 1Homo sapiens (human)
signal transductionGlutamate receptor 1Homo sapiens (human)
chemical synaptic transmissionGlutamate receptor 1Homo sapiens (human)
synapse assemblyGlutamate receptor 1Homo sapiens (human)
long-term memoryGlutamate receptor 1Homo sapiens (human)
response to xenobiotic stimulusGlutamate receptor 1Homo sapiens (human)
response to lithium ionGlutamate receptor 1Homo sapiens (human)
positive regulation of gene expressionGlutamate receptor 1Homo sapiens (human)
neuronal action potentialGlutamate receptor 1Homo sapiens (human)
calcium-mediated signalingGlutamate receptor 1Homo sapiens (human)
spinal cord developmentGlutamate receptor 1Homo sapiens (human)
cerebral cortex developmentGlutamate receptor 1Homo sapiens (human)
receptor internalizationGlutamate receptor 1Homo sapiens (human)
response to estradiolGlutamate receptor 1Homo sapiens (human)
monoatomic ion transmembrane transportGlutamate receptor 1Homo sapiens (human)
ionotropic glutamate receptor signaling pathwayGlutamate receptor 1Homo sapiens (human)
response to cocaineGlutamate receptor 1Homo sapiens (human)
positive regulation of membrane potentialGlutamate receptor 1Homo sapiens (human)
response to arsenic-containing substanceGlutamate receptor 1Homo sapiens (human)
response to electrical stimulusGlutamate receptor 1Homo sapiens (human)
regulation of postsynaptic membrane potentialGlutamate receptor 1Homo sapiens (human)
long-term synaptic potentiationGlutamate receptor 1Homo sapiens (human)
long-term synaptic depressionGlutamate receptor 1Homo sapiens (human)
response to fungicideGlutamate receptor 1Homo sapiens (human)
cellular response to amino acid stimulusGlutamate receptor 1Homo sapiens (human)
cellular response to ammonium ionGlutamate receptor 1Homo sapiens (human)
cellular response to dsRNAGlutamate receptor 1Homo sapiens (human)
cellular response to peptide hormone stimulusGlutamate receptor 1Homo sapiens (human)
cellular response to amine stimulusGlutamate receptor 1Homo sapiens (human)
regulation of presynaptic membrane potentialGlutamate receptor 1Homo sapiens (human)
regulation of postsynaptic cytosolic calcium ion concentrationGlutamate receptor 1Homo sapiens (human)
cellular response to brain-derived neurotrophic factor stimulusGlutamate receptor 1Homo sapiens (human)
modulation of chemical synaptic transmissionGlutamate receptor 1Homo sapiens (human)
synaptic transmission, glutamatergicGlutamate receptor 1Homo sapiens (human)
signal transductionGlutamate receptor 2Homo sapiens (human)
chemical synaptic transmissionGlutamate receptor 2Homo sapiens (human)
ionotropic glutamate receptor signaling pathwayGlutamate receptor 2Homo sapiens (human)
synaptic transmission, glutamatergicGlutamate receptor 2Homo sapiens (human)
regulation of postsynaptic membrane potentialGlutamate receptor 2Homo sapiens (human)
monoatomic cation transmembrane transportGlutamate receptor 2Homo sapiens (human)
modulation of chemical synaptic transmissionGlutamate receptor 2Homo sapiens (human)
glutamate receptor signaling pathwayGlutamate receptor 3Homo sapiens (human)
calcium-mediated signalingGlutamate receptor 3Homo sapiens (human)
monoatomic ion transmembrane transportGlutamate receptor 3Homo sapiens (human)
ionotropic glutamate receptor signaling pathwayGlutamate receptor 3Homo sapiens (human)
protein homotetramerizationGlutamate receptor 3Homo sapiens (human)
protein heterotetramerizationGlutamate receptor 3Homo sapiens (human)
regulation of postsynaptic membrane potentialGlutamate receptor 3Homo sapiens (human)
long-term synaptic potentiationGlutamate receptor 3Homo sapiens (human)
regulation of presynaptic membrane potentialGlutamate receptor 3Homo sapiens (human)
modulation of chemical synaptic transmissionGlutamate receptor 3Homo sapiens (human)
synaptic transmission, glutamatergicGlutamate receptor 3Homo sapiens (human)
monoatomic ion transportSolute carrier family 15 member 1Homo sapiens (human)
protein transportSolute carrier family 15 member 1Homo sapiens (human)
peptide transportSolute carrier family 15 member 1Homo sapiens (human)
dipeptide import across plasma membraneSolute carrier family 15 member 1Homo sapiens (human)
tripeptide import across plasma membraneSolute carrier family 15 member 1Homo sapiens (human)
proton transmembrane transportSolute carrier family 15 member 1Homo sapiens (human)
glutamate receptor signaling pathwayGlutamate receptor 4Homo sapiens (human)
monoatomic ion transmembrane transportGlutamate receptor 4Homo sapiens (human)
negative regulation of smooth muscle cell apoptotic processGlutamate receptor 4Homo sapiens (human)
ionotropic glutamate receptor signaling pathwayGlutamate receptor 4Homo sapiens (human)
regulation of postsynaptic membrane potentialGlutamate receptor 4Homo sapiens (human)
regulation of presynaptic membrane potentialGlutamate receptor 4Homo sapiens (human)
modulation of chemical synaptic transmissionGlutamate receptor 4Homo sapiens (human)
synaptic transmission, glutamatergicGlutamate receptor 4Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (33)

Processvia Protein(s)Taxonomy
GABA-A receptor activityGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
protein domain specific bindingGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
GABA-gated chloride ion channel activityGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
identical protein bindingGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
protein-containing complex bindingGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
ligand-gated monoatomic ion channel activity involved in regulation of presynaptic membrane potentialGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
neurotransmitter receptor activityGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
chloride channel activityGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
amyloid-beta bindingGlutamate receptor 1Homo sapiens (human)
G-protein alpha-subunit bindingGlutamate receptor 1Homo sapiens (human)
AMPA glutamate receptor activityGlutamate receptor 1Homo sapiens (human)
protein bindingGlutamate receptor 1Homo sapiens (human)
glutamate receptor activityGlutamate receptor 1Homo sapiens (human)
adenylate cyclase bindingGlutamate receptor 1Homo sapiens (human)
immunoglobulin bindingGlutamate receptor 1Homo sapiens (human)
protein kinase bindingGlutamate receptor 1Homo sapiens (human)
glutamate-gated calcium ion channel activityGlutamate receptor 1Homo sapiens (human)
PDZ domain bindingGlutamate receptor 1Homo sapiens (human)
small GTPase bindingGlutamate receptor 1Homo sapiens (human)
myosin V bindingGlutamate receptor 1Homo sapiens (human)
G-protein beta-subunit bindingGlutamate receptor 1Homo sapiens (human)
beta-2 adrenergic receptor bindingGlutamate receptor 1Homo sapiens (human)
glutamate receptor bindingGlutamate receptor 1Homo sapiens (human)
identical protein bindingGlutamate receptor 1Homo sapiens (human)
protein kinase A bindingGlutamate receptor 1Homo sapiens (human)
scaffold protein bindingGlutamate receptor 1Homo sapiens (human)
ligand-gated monoatomic ion channel activity involved in regulation of presynaptic membrane potentialGlutamate receptor 1Homo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potentialGlutamate receptor 1Homo sapiens (human)
neurotransmitter receptor activity involved in regulation of postsynaptic cytosolic calcium ion concentrationGlutamate receptor 1Homo sapiens (human)
AMPA glutamate receptor activityGlutamate receptor 2Homo sapiens (human)
amyloid-beta bindingGlutamate receptor 2Homo sapiens (human)
glutamate-gated receptor activityGlutamate receptor 2Homo sapiens (human)
AMPA glutamate receptor activityGlutamate receptor 2Homo sapiens (human)
protein bindingGlutamate receptor 2Homo sapiens (human)
ligand-gated monoatomic cation channel activityGlutamate receptor 2Homo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potentialGlutamate receptor 2Homo sapiens (human)
amyloid-beta bindingGlutamate receptor 3Homo sapiens (human)
glutamate-gated receptor activityGlutamate receptor 3Homo sapiens (human)
AMPA glutamate receptor activityGlutamate receptor 3Homo sapiens (human)
glutamate-gated calcium ion channel activityGlutamate receptor 3Homo sapiens (human)
ligand-gated monoatomic ion channel activity involved in regulation of presynaptic membrane potentialGlutamate receptor 3Homo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potentialGlutamate receptor 3Homo sapiens (human)
proton-dependent oligopeptide secondary active transmembrane transporter activitySolute carrier family 15 member 1Homo sapiens (human)
peptide:proton symporter activitySolute carrier family 15 member 1Homo sapiens (human)
tripeptide transmembrane transporter activitySolute carrier family 15 member 1Homo sapiens (human)
dipeptide transmembrane transporter activitySolute carrier family 15 member 1Homo sapiens (human)
amyloid-beta bindingGlutamate receptor 4Homo sapiens (human)
glutamate-gated receptor activityGlutamate receptor 4Homo sapiens (human)
AMPA glutamate receptor activityGlutamate receptor 4Homo sapiens (human)
ligand-gated monoatomic ion channel activity involved in regulation of presynaptic membrane potentialGlutamate receptor 4Homo sapiens (human)
transmitter-gated monoatomic ion channel activity involved in regulation of postsynaptic membrane potentialGlutamate receptor 4Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (47)

Processvia Protein(s)Taxonomy
plasma membraneGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
presynaptic membraneGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
postsynaptic membraneGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
glutamatergic synapseGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
GABA-ergic synapseGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
chloride channel complexGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
GABA-A receptor complexGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
transmembrane transporter complexGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
neuron projectionGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
synapseGamma-aminobutyric acid receptor subunit rho-1Homo sapiens (human)
endoplasmic reticulum membraneGlutamate receptor 1Homo sapiens (human)
plasma membraneGlutamate receptor 1Homo sapiens (human)
cell-cell junctionGlutamate receptor 1Homo sapiens (human)
cell surfaceGlutamate receptor 1Homo sapiens (human)
ER to Golgi transport vesicle membraneGlutamate receptor 1Homo sapiens (human)
postsynaptic densityGlutamate receptor 1Homo sapiens (human)
dendriteGlutamate receptor 1Homo sapiens (human)
endocytic vesicle membraneGlutamate receptor 1Homo sapiens (human)
synaptic vesicle membraneGlutamate receptor 1Homo sapiens (human)
neuromuscular junctionGlutamate receptor 1Homo sapiens (human)
early endosome membraneGlutamate receptor 1Homo sapiens (human)
dendritic spine membraneGlutamate receptor 1Homo sapiens (human)
neuronal cell body membraneGlutamate receptor 1Homo sapiens (human)
endoplasmic reticulum-Golgi intermediate compartment membraneGlutamate receptor 1Homo sapiens (human)
neuronal cell bodyGlutamate receptor 1Homo sapiens (human)
dendritic spineGlutamate receptor 1Homo sapiens (human)
dendritic shaftGlutamate receptor 1Homo sapiens (human)
axonal spineGlutamate receptor 1Homo sapiens (human)
neuron spineGlutamate receptor 1Homo sapiens (human)
postsynaptic membraneGlutamate receptor 1Homo sapiens (human)
presynaptic active zone membraneGlutamate receptor 1Homo sapiens (human)
recycling endosomeGlutamate receptor 1Homo sapiens (human)
recycling endosome membraneGlutamate receptor 1Homo sapiens (human)
excitatory synapseGlutamate receptor 1Homo sapiens (human)
synaptic membraneGlutamate receptor 1Homo sapiens (human)
presynapseGlutamate receptor 1Homo sapiens (human)
postsynaptic density membraneGlutamate receptor 1Homo sapiens (human)
glutamatergic synapseGlutamate receptor 1Homo sapiens (human)
postsynaptic density, intracellular componentGlutamate receptor 1Homo sapiens (human)
perisynaptic spaceGlutamate receptor 1Homo sapiens (human)
AMPA glutamate receptor complexGlutamate receptor 1Homo sapiens (human)
plasma membraneGlutamate receptor 1Homo sapiens (human)
dendritic spineGlutamate receptor 1Homo sapiens (human)
postsynaptic density membraneGlutamate receptor 1Homo sapiens (human)
plasma membraneGlutamate receptor 2Homo sapiens (human)
external side of plasma membraneGlutamate receptor 2Homo sapiens (human)
postsynaptic densityGlutamate receptor 2Homo sapiens (human)
dendriteGlutamate receptor 2Homo sapiens (human)
endocytic vesicle membraneGlutamate receptor 2Homo sapiens (human)
asymmetric synapseGlutamate receptor 2Homo sapiens (human)
neuronal cell bodyGlutamate receptor 2Homo sapiens (human)
dendritic spineGlutamate receptor 2Homo sapiens (human)
excitatory synapseGlutamate receptor 2Homo sapiens (human)
postsynapseGlutamate receptor 2Homo sapiens (human)
postsynaptic endocytic zoneGlutamate receptor 2Homo sapiens (human)
AMPA glutamate receptor complexGlutamate receptor 2Homo sapiens (human)
plasma membraneGlutamate receptor 2Homo sapiens (human)
dendritic spineGlutamate receptor 2Homo sapiens (human)
postsynaptic density membraneGlutamate receptor 2Homo sapiens (human)
plasma membraneGlutamate receptor 3Homo sapiens (human)
endocytic vesicle membraneGlutamate receptor 3Homo sapiens (human)
postsynaptic membraneGlutamate receptor 3Homo sapiens (human)
parallel fiber to Purkinje cell synapseGlutamate receptor 3Homo sapiens (human)
AMPA glutamate receptor complexGlutamate receptor 3Homo sapiens (human)
plasma membraneGlutamate receptor 3Homo sapiens (human)
postsynaptic density membraneGlutamate receptor 3Homo sapiens (human)
dendritic spineGlutamate receptor 3Homo sapiens (human)
plasma membraneSolute carrier family 15 member 1Homo sapiens (human)
brush borderSolute carrier family 15 member 1Homo sapiens (human)
membraneSolute carrier family 15 member 1Homo sapiens (human)
apical plasma membraneSolute carrier family 15 member 1Homo sapiens (human)
plasma membraneSolute carrier family 15 member 1Homo sapiens (human)
apical plasma membraneSolute carrier family 15 member 1Homo sapiens (human)
plasma membraneGlutamate receptor 4Homo sapiens (human)
dendriteGlutamate receptor 4Homo sapiens (human)
endocytic vesicle membraneGlutamate receptor 4Homo sapiens (human)
neuronal cell bodyGlutamate receptor 4Homo sapiens (human)
dendritic spineGlutamate receptor 4Homo sapiens (human)
extracellular vesicleGlutamate receptor 4Homo sapiens (human)
AMPA glutamate receptor complexGlutamate receptor 4Homo sapiens (human)
postsynaptic density membraneGlutamate receptor 4Homo sapiens (human)
plasma membraneGlutamate receptor 4Homo sapiens (human)
dendritic spineGlutamate receptor 4Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (143)

Assay IDTitleYearJournalArticle
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID519392Antibacterial activity against Escherichia coli Ti05 assessed as microbial survival fraction incubated at 1 mM followed by irradiation at 120 J.cm2 light relative to untreated control2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID625288Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1564443Chemical stability of the compound in buffer at 1M at pH 7.4 by HPLC analysis2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID371991Drug uptake in human Caco-2 cells assessed as intracellular 5-aminolaevulinic acid level per mg of protein at 1 mM after 4 hrs2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID347424Induction of apoptosis in human U251 cells assessed as viable cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry in presence of Z-Asp-2,6-dichlorobenzoyloxymethylketone2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1564474Photosensitization activity against human A375 cells assessed as cell viability at 100 uM incubated for 4 hrs followed by LED light array irradiation followed by further incubation for 24 hrs by MTT assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID588970Substrates of transporters of clinical importance in the absorption and disposition of drugs, PEPT12010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID371986Drug uptake in mouse PAM212 cells assessed as PpIX production per mg of protein at 0.1 mM after 4 hrs2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID1481967Drug metabolism in human KB cells assessed as protoporphyrin 9 formation at 500 uM preincubated for 1 hr at 4 degC followed by compound washout and subsequent incubation for 4 hrs at 37 degC by fluorescence spectrometer2017Journal of medicinal chemistry, 04-27, Volume: 60, Issue:8
Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
AID371992Drug uptake in human Caco-2 cells assessed as PpIX production per mg of protein at 1 mM after 4 hrs2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID519379Antibacterial activity against Escherichia coli K-12 assessed as reduction in microbial viability incubated at 0.1 mM followed by irradiation at 120 J.cm2 light2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID1481987Drug metabolism in human doxorubicin resistant MCF7/R cells assessed as formation of protoporphyrin 9 at 100 uM after 6 hrs by fluorescence spectrometer2017Journal of medicinal chemistry, 04-27, Volume: 60, Issue:8
Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID371985Drug uptake in mouse PAM212 cells assessed as intracellular 5-aminolaevulinic acid level per mg of protein at 0.1 mM after 4 hrs2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID347584Induction of apoptosis in human U251 cells assessed as increase in full length caspase 8 level after 24 hrs by Western blot2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID519395Induction of photoactive porphyrins in Escherichia coli K-12 assessed as porphyrin level per 10'-6 CFU microbial load incubated at 0.1 mM followed by irradiation at 120 J.cm2 light relative to untreated control2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID347413Inhibition of 26S proteasome activity in human U251 cells at 100 uM after 48 hrs in presence of N-acetyl-L-cysteine relative to control2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID625279Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID625289Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625284Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID519383Induction of photoactive porphyrins in Escherichia coli K-12 assessed as protoporphyrin level exposed to irradiation at 120 J.cm2 light by HPLC2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID519398Induction of photoactive porphyrins in methicillin resistant Staphylococcus aureus assessed as porphyrin level per 10'-6 CFU microbial load incubated at 10 mM followed by irradiation at 120 J.cm2 light relative to untreated control2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID625285Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID519393Antibacterial activity against Pseudomonas aeruginosa assessed as microbial survival fraction incubated at 1 mM followed by irradiation at 120 J.cm2 light relative to untreated control2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID519382Induction of photoactive porphyrins in Escherichia coli K-12 assessed as uroporphyrin level exposed to irradiation at 120 J.cm2 light by HPLC2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1481976Phototoxicity in human CNE2 cells assessed as reduction in cell viability preincubated for 4 hrs followed by irradiation with 6 J/cm2 light dose measured after 24 hrs by MTT assay2017Journal of medicinal chemistry, 04-27, Volume: 60, Issue:8
Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
AID347583Induction of apoptosis in human U251 cells assessed as late apoptotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry in presence of Z-Asp-2,6-dichlorobenzoyloxymethylketone2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1564473Photosensitization activity against human A549 cells assessed as cell viability at 100 uM incubated for 4 hrs followed by LED light array irradiation followed by further incubation for 24 hrs by MTT assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID519378Antibacterial activity against Escherichia coli K-12 assessed as reduction in microbial viability incubated at <40 mM for 4 hrs under dark condition2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1551993Photodynamic antibacterial activity against Helicobacter pylori infected in patient assessed as bacterial eradication at 20 mg/lg, po after 4 hrs in presence of white light relative to control2019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID347422Induction of apoptosis in human U251 cells assessed as late apoptotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID347419Induction of apoptosis in human U251 cells assessed as viable cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID625281Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID347404Increase in heme level in human U251 cells assessed as porphobilinogen deaminase level at 100 uM after 2 hrs by Western blot relative to control2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1564461Prodrug activation in human HeLa cells assessed as increase in GSH-mediated PpIX production at 100 uM incubated for 4 hrs by fluorescence imaging analysis2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID462613Permeability across artificial membrane assessed as membrane retention at 200 uM by PAMPA using HPLC/MS method2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
N-methyl phenylalanine-rich peptides as highly versatile blood-brain barrier shuttles.
AID347403Increase in heme level in human U251 cells at 100 uM after 48 hrs by Western blot relative to control2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID347405Increase in heme level in human U251 cells assessed as porphobilinogen deaminase level at 100 uM after 2 hrs by Western blot in presence of cycloheximide2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID519381Induction of photoactive porphyrins in Escherichia coli K-12 exposed to irradiation at 120 J.cm2 light by HPLC2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID347393Cytotoxicity against human HL60 cells after 72 hrs by MTT assay2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1481973Phototoxicity in human MCF7 cells assessed as reduction in cell viability preincubated for 4 hrs followed by irradiation with blue light at 2.5 J/cm2 and subsequent incubation for 18 hrs measured after 24 hrs post treatment by MTT assay2017Journal of medicinal chemistry, 04-27, Volume: 60, Issue:8
Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
AID1481992Dark toxicity against human KB cells assessed as cell survival at 100 uM after 24 hrs by MTT assay2017Journal of medicinal chemistry, 04-27, Volume: 60, Issue:8
Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1481974Phototoxicity in human doxorubicin resistant MCF7/R cells assessed as reduction in cell viability preincubated for 4 hrs followed by irradiation with blue light at 2.5 J/cm2 and subsequent incubation for 18 hrs measured after 24 hrs post treatment by MTT 2017Journal of medicinal chemistry, 04-27, Volume: 60, Issue:8
Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
AID371988Drug uptake in mouse PAM212 cells assessed as PpIX production per mg of protein at 1 mM after 4 hrs2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID1481979Dark toxicity against human KB cells at 200 uM preincubated for 4 hrs followed by compound washout measured after 24 hrs by MTT assay2017Journal of medicinal chemistry, 04-27, Volume: 60, Issue:8
Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
AID519396Induction of photoactive porphyrins in Escherichia coli Ti05 assessed as porphyrin level per 10'-6 CFU microbial load incubated at 1 mM followed by irradiation at 120 J.cm2 light relative to untreated control2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID1481972Phototoxicity in human KB cells assessed as reduction in cell viability preincubated for 4 hrs followed by irradiation with blue light at 2.5 J/cm2 and subsequent incubation for 18 hrs measured after 24 hrs post treatment by MTT assay2017Journal of medicinal chemistry, 04-27, Volume: 60, Issue:8
Hydroxypyridinone and 5-Aminolaevulinic Acid Conjugates for Photodynamic Therapy.
AID625280Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID347395Cytotoxicity against human MCF7/DX cells after 72 hrs by Hoechst test2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1304414Cytotoxicity against human A431 cells assessed as reduction in cell viability at 2 uM preincubated for 4 hrs followed by 5 J/cm'-2 red light irradiation measured after 24 hrs by MTT assay relative to control2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Comparing the efficacy of photodynamic and sonodynamic therapy in non-melanoma and melanoma skin cancer.
AID347396Increase in ROS production in human U251 cells at 100 uM after 4 hrs by FACS2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID625291Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625283Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID347418Induction of apoptosis in human U251 cells assessed as viable cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry in presence of Ac-LEHD-CHO2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID92023Inhibition constant (Ki) for human intestinal peptide carrier2003Journal of medicinal chemistry, Dec-18, Volume: 46, Issue:26
Three-dimensional quantitative structure-activity relationship analyses of peptide substrates of the mammalian H+/peptide cotransporter PEPT1.
AID371989Drug uptake in human A549 cells assessed as intracellular 5-aminolaevulinic acid level per mg of protein at 0.1 mM after 4 hrs2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID519397Induction of photoactive porphyrins in Pseudomonas aeruginosa assessed as porphyrin level per 10'-6 CFU microbial load incubated at 1 mM followed by irradiation at 120 J.cm2 light relative to untreated control2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID347406Increase in protoporphyrin 9 levels in human U251 cells at 100 uM after 24 hrs relative to control2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1564486Prodrug activation in human HCT116 cells assessed as increase in GSH-mediated PpIX production at 100 to 300 uM incubated for 4 hrs by fluorescence based assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID1564444Chemical stability of the compound in buffer at 1M at pH 9 by HPLC analysis2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID519380Antibacterial activity against Escherichia coli K-12 assessed as reduction in microbial viability incubated at 40 mM followed by irradiation at 120 J.cm2 light2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID519391Antibacterial activity against Escherichia coli K-12 assessed as microbial survival fraction incubated at 0.1 mM followed by irradiation at 120 J.cm2 light relative to untreated control2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID1304417Cytotoxicity against human A431 cells assessed as reduction in cell viability at 1 uM preincubated for 4 hrs followed by 90 J/cm'-2 ultrasound irradiation measured after 24 hrs by MTT assay2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Comparing the efficacy of photodynamic and sonodynamic therapy in non-melanoma and melanoma skin cancer.
AID625282Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID347416Induction of apoptosis in human U251 cells assessed as early apoptotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry in presence of Ac-LEHD-CHO2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID347417Induction of necrosis in human U251 cells assessed as necrotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry in presence of Ac-LEHD-CHO2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1564488Prodrug activation in human A375 cells assessed as increase in GSH-mediated PpIX production at 100 to 300 uM incubated for 4 hrs by fluorescence based assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID625292Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID519389Antibacterial activity against Escherichia coli K-12 assessed as reduction in microbial viability incubated at 40 mM for 4 hrs under dark condition2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID406571Antagonist activity at human GABAc Rho1 receptor expressed in Xenopus oocytes assessed as whole cell current production by two electrode voltage clamp method2008Journal of medicinal chemistry, Jul-10, Volume: 51, Issue:13
Novel gamma-aminobutyric acid rho1 receptor antagonists; synthesis, pharmacological activity and structure-activity relationships.
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID371987Drug uptake in mouse PAM212 cells assessed as intracellular 5-aminolaevulinic acid level per mg of protein at 1 mM after 4 hrs2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID347423Induction of apoptosis in human U251 cells assessed as late apoptotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry in presence of Ac-LEHD-CHO2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1564464Photosensitization activity against human HeLa cells assessed as reduction in cell viability incubated for 4 hrs followed by LED light array irradiation followed by further incubation for 24 hrs by MTT assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID462612Permeability across artificial membrane assessed as compound transport at 200 uM after 4 hrs by PAMPA using HPLC/MS method2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
N-methyl phenylalanine-rich peptides as highly versatile blood-brain barrier shuttles.
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1564458Prodrug activation in human HeLa cells assessed as increase in GSH-mediated PpIX production at 300 uM incubated for 4 hrs by fluorescence based assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID347412Inhibition of 26S proteasome activity in human U251 cells at 100 uM after 48 hrs relative to control2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID588971Substrates of transporters of clinical importance in the absorption and disposition of drugs, PEPT22010Nature reviews. Drug discovery, Mar, Volume: 9, Issue:3
Membrane transporters in drug development.
AID625286Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID347408Antiproliferative activity against human U251 cells assessed as PpIX release after 72 hrs by Hoechst test2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1564487Prodrug activation in human A549 cells assessed as increase in GSH-mediated PpIX production at 100 to 300 uM incubated for 4 hrs by fluorescence based assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID681124TP_TRANSPORTER: inhibition of Gly-Sar uptake in PEPT2-expressing LLC-PK1 cells2000Pflugers Archiv : European journal of physiology, Sep, Volume: 440, Issue:5
Structural requirements for determining the substrate affinity of peptide transporters PEPT1 and PEPT2.
AID477295Octanol-water partition coefficient, log P of the compound2010European journal of medicinal chemistry, Apr, Volume: 45, Issue:4
QSPR modeling of octanol/water partition coefficient of antineoplastic agents by balance of correlations.
AID347394Cytotoxicity against human MCF7 cells after 72 hrs by Hoechst test2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1552007Photodynamic antibacterial activity against Helicobacter pylori infected in patient assessed as bacterial eradication at 20 mg/lg, po after 4 hrs in presence of blue light relative to control2019European journal of medicinal chemistry, Aug-01, Volume: 175Porphyrinoid photosensitizers mediated photodynamic inactivation against bacteria.
AID347420Induction of necrosis in human U251 cells assessed as necrotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1564442Chemical stability of the compound in buffer at 1M at pH 4 by HPLC analysis2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID1564482Cytotoxicity against human HeLa cells assessed as cell viability at 10 to 1000 uM incubated for 4 hrs measured under dark conditions by MTT assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID625290Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1304416Cytotoxicity against human A431 cells assessed as reduction in cell viability at 2 uM preincubated for 4 hrs followed by 90 J/cm'-2 ultrasound irradiation measured after 24 hrs by MTT assay relative to control2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Comparing the efficacy of photodynamic and sonodynamic therapy in non-melanoma and melanoma skin cancer.
AID1564465Photosensitization activity against human HeLa cells assessed as cell viability at 100 uM incubated for 4 hrs followed by LED light array irradiation followed by further incubation for 24 hrs by MTT assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID371994Phototoxicity against mouse PAM212 cells assessed as cell viability at 0.01 mM after 4 hrs irradiated with 2.5 J/cm2 blue light by MTT assay relative to control2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID347426Induction of apoptosis in human U251 cells assessed as early apoptotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry in presence of Z-Asp-2,6-dichlorobenzoyloxymethylketone2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID347411Inhibition of 26S proteasome activity in human U251 cells at 1 mM after 48 hrs2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID347397Increase in ROS production in human U251 cells at 100 uM after 4 hrs by FACS in presence of N-acetyl-L-cysteine2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID371993Phototoxicity against mouse PAM212 cells assessed as cell viability at 0.1 mM after 4 hrs irradiated with 2.5 J/cm2 blue light by MTT assay relative to control2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID1564480n-octanol/water partition coefficient, log P of the compound at 1M incubated for 0.5 hrs by HPLC analysis2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID681125TP_TRANSPORTER: inhibition of Gly-Sar uptake in PEPT1-expressing LLC-PK1 cells2000Pflugers Archiv : European journal of physiology, Sep, Volume: 440, Issue:5
Structural requirements for determining the substrate affinity of peptide transporters PEPT1 and PEPT2.
AID625287Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly2011PLoS computational biology, Dec, Volume: 7, Issue:12
Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID347409Antiproliferative activity against human U251 cells assessed as PpIX release pretreated 72 hrs before 360-410 nm light photosensitization measured after 48 hrs by Hoechst test2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID519394Antibacterial activity against methicillin resistant Staphylococcus aureus assessed as microbial survival fraction incubated at 10 mM followed by irradiation at 120 J.cm2 light relative to untreated control2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Effects on gram-negative and gram-positive bacteria mediated by 5-aminolevulinic Acid and 5-aminolevulinic acid derivatives.
AID1304415Cytotoxicity against human A431 cells assessed as reduction in cell viability at 1 uM preincubated for 4 hrs followed by 5 J/cm'-2 red light irradiation measured after 24 hrs by MTT assay2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Comparing the efficacy of photodynamic and sonodynamic therapy in non-melanoma and melanoma skin cancer.
AID1564455Prodrug activation in human HeLa cells assessed as increase in GSH-mediated PpIX production at 10 to 300 uM incubated for 4 hrs by fluorescence based assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID347421Induction of apoptosis in human U251 cells assessed as early apoptotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID462611Effective permeability across artificial membrane at 200 uM by PAMPA using HPLC/MS method2010Journal of medicinal chemistry, Mar-25, Volume: 53, Issue:6
N-methyl phenylalanine-rich peptides as highly versatile blood-brain barrier shuttles.
AID347407Increase in protoporphyrin 9 levels in human U251 cells at 200 uM after 24 hrs relative to control2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID1564472Photosensitization activity against human HCT116 cells assessed as cell viability at 100 uM incubated for 4 hrs followed by LED light array irradiation followed by further incubation for 24 hrs by MTT assay2019European journal of medicinal chemistry, Nov-01, Volume: 181A new GSH-responsive prodrug of 5-aminolevulinic acid for photodiagnosis and photodynamic therapy of tumors.
AID347425Induction of necrosis in human U251 cells assessed as necrotic cells at 100 uM after 48 hrs using annexin-V FITC and PI staining by flow cytometry in presence of Z-Asp-2,6-dichlorobenzoyloxymethylketone2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID347392Cytotoxicity against human U251 cells after 72 hrs by Hoechst test2008Journal of medicinal chemistry, Dec-11, Volume: 51, Issue:23
Novel multifunctional acyloxyalkyl ester prodrugs of 5-aminolevulinic acid display improved anticancer activity independent and dependent on photoactivation.
AID371990Drug uptake in human A549 cells assessed as PpIX production per mg of protein at 0.1 mM after 4 hrs2009Journal of medicinal chemistry, Jul-09, Volume: 52, Issue:13
Improved peptide prodrugs of 5-ALA for PDT: rationalization of cellular accumulation and protoporphyrin IX production by direct determination of cellular prodrug uptake and prodrug metabolization.
AID1745854NCATS anti-infectives library activity on HEK293 viability as a counter-qHTS vs the C. elegans viability qHTS2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1745855NCATS anti-infectives library activity on the primary C. elegans qHTS viability assay2023Disease models & mechanisms, 03-01, Volume: 16, Issue:3
In vivo quantitative high-throughput screening for drug discovery and comparative toxicology.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (6,160)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990912 (14.81)18.7374
1990's774 (12.56)18.2507
2000's1537 (24.95)29.6817
2010's2054 (33.34)24.3611
2020's883 (14.33)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 57.43

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index57.43 (24.57)
Research Supply Index8.87 (2.92)
Research Growth Index4.78 (4.65)
Search Engine Demand Index198.39 (26.88)
Search Engine Supply Index3.90 (0.95)

This Compound (57.43)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials665 (10.27%)5.53%
Reviews599 (9.25%)6.00%
Case Studies619 (9.56%)4.05%
Observational33 (0.51%)0.25%
Other4,559 (70.41%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (152)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 1 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain [NCT01148966]Phase 16 participants (Actual)Interventional2010-06-30Terminated
Noninvasive Imaging Techniques to Monitor Photosensitizer and Singlet Oxygen Levels During Photodynamic Therapy of Actinic Keratoses [NCT05923060]Phase 220 participants (Anticipated)Interventional2024-04-30Not yet recruiting
A Non-randomized, Open-label, Multicenter Study to Evaluate the Safety and Tolerability of BF-200 ALA (Ameluz®) in the Expanded Field-directed Treatment of Actinic Keratosis on the Face and Scalp With Photodynamic Therapy (PDT) [NCT05060237]Phase 1100 participants (Actual)Interventional2021-12-01Completed
A Randomized, Double Blind, Vehicle-controlled, Multicenter Phase II Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Moderate to Severe Acne Vulgaris in Adults With Photodynamic Therapy (PDT) [NCT05080764]Phase 2126 participants (Anticipated)Interventional2021-12-10Recruiting
Subject Reported Outcomes on Satisfaction, Safety and Efficacy With Luxerm® in the Field-directed Treatment of Thin or Non-hyperkeratotic and Non-pigmented Actinic Keratosis of the Face or the Scalp [NCT03511326]Phase 450 participants (Actual)Interventional2017-06-07Completed
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Small Genital Warts:a Randomized, Open-label Trial [NCT03948321]20 participants (Anticipated)Interventional2019-05-10Recruiting
An Open-label Phase I Study to Evaluate the Pharmacokinetics of 5-aminolevulinic Acid and Protoporphyrin IX in Human Plasma Under Maximal Use Conditions After Topical Application of 3 Tubes of BF-200 ALA 10% Gel for Photodynamic Therapy (PDT) in Subjects [NCT04319159]Phase 148 participants (Actual)Interventional2020-03-05Completed
Clinical Study of the Utility of a Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas [NCT04055688]20 participants (Actual)Observational2019-08-15Completed
Photodynamic Therapy for Papulopustular Rosacea [NCT02075671]Phase 430 participants (Actual)Interventional2014-04-24Completed
A Phase 3 Multicenter Study of Gleolan (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Newly Diagnosed or Recurrent Meningiomas [NCT04305470]Phase 3108 participants (Actual)Interventional2020-10-28Active, not recruiting
A Randomized, Double-Blind, Phase III Multi-Center Study Evaluating the Safety and Efficacy of BF-200 ALA Versus Placebo in the Treatment of Actinic Keratosis (AK) When Using PDT [NCT02799082]Phase 3122 participants (Actual)Interventional2007-12-31Completed
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain [NCT01351519]Phase 216 participants (Actual)Interventional2011-05-31Terminated(stopped due to Limited staff available for enrollment and limited availability of drug)
Surgical Excision Versus Photodynamic Therapy and Topical 5-fluorouracil in Treatment of Bowen's Disease: a Multicenter Randomized Controlled Trial [NCT03909646]Phase 4250 participants (Anticipated)Interventional2019-05-27Recruiting
A Phase I Study for Superficial Basal Cell Carcinoma to Determine the Irradiance - Dependent Pain Threshold for Methylaminolevulinate (MAL)/PDT. [NCT01292668]Phase 121 participants (Actual)Interventional2011-03-31Completed
A Prospective Multi-center Clinical Study Evaluating the Use of PD G 506 A and the Eagle V1.2 Imaging System for the Visualization of Carcinoma During Breast Conserving Surgery [NCT04815083]Phase 3370 participants (Anticipated)Interventional2021-04-27Recruiting
Use of 5-Aminolevulinic Acid to Assess Bone and Tissue Profusion in Orthopaedic Infection Patients [NCT04976049]0 participants (Actual)Observational2021-08-13Withdrawn(stopped due to Principle Investigator decided not to pursue study)
Aminolevulinic Acid-photodynamic Therapy for Facial Actinic Keratosis Treatment and Prevention: A Long-term (3 Years) Follow-up of Prospective, Randomized, Multicenter-clinical Trial [NCT03642535]Phase 4300 participants (Anticipated)Interventional2018-08-30Recruiting
5-Aminolevulinic Acid (5-ALA) Gliolan®: Usage Increase Proposal for Neurosurgical Procedures in High-Grade Gliomas [NCT05850377]90 participants (Anticipated)Observational2023-06-01Not yet recruiting
Barrow ALA Trial for Recurrent Gliomas [NCT02119338]60 participants (Anticipated)Interventional2014-02-28Recruiting
A Double-blind Randomized-controlled Trial to Assess the Efficacy of Methyl Aminolevulinate + Daylight vs Placebo + Daylight in Patients With Facial Photodamage [NCT02139618]Phase 260 participants (Actual)Interventional2014-04-30Completed
An Investigator Initiated Study to Evaluate the Safety and Efficacy of Aminolevulinic Acid 20% Topical Solution (Levulan® Kerastick®) (ALA) + Blue Light in the Treatment of Facial Cutaneous Squamous Cell Carcinoma in Situ (isSCC) [NCT06159842]Phase 220 participants (Anticipated)Interventional2023-08-08Recruiting
A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of a Nanoemulsion Gel Formulation BF-200 ALA, in Comparison With Metvix® and Placebo, for the Treatment of Actinic Keratosis With PDT [NCT02799069]Phase 3571 participants (Actual)Interventional2008-04-30Completed
Twelve Month Follow-Up Evaluation of Subjects Participating in DUSA-CP0108 (A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on [NCT02209012]206 participants (Actual)Observational2014-08-31Completed
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Moderate or Severe Acne#a Randomized, Open-label Trial [NCT03961607]20 participants (Anticipated)Interventional2019-05-10Recruiting
A Phase 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Primary Glial Neoplasms of the Brain. [NCT00961090]Phase 272 participants (Actual)Interventional2009-09-30Completed
Blue Light Cystoscopy With Cysview® Registry [NCT02660645]4,400 participants (Anticipated)Observational [Patient Registry]2014-04-30Recruiting
A Double-blind, Placebo Controlled Study to Assess Efficacy of 5-Aminolevulinic Acid in Subjects With Iron Deficiency Anemia [NCT01380548]135 participants (Anticipated)Interventional2011-06-30Completed
An Evaluation of the Tolerability and Feasibility of Combining 5-Amino-Levulinic Acid (5-ALA) With Carmustine Wafers (Gliadel) in the Surgical Management of Primary Glioblastoma (GALA-5 Trial) [NCT01310868]Phase 259 participants (Actual)Interventional2011-05-31Completed
A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage [NCT00629317]Phase 349 participants (Actual)Interventional2008-02-29Completed
A Randomized, Double Blind, Vehicle-controlled Multicenter Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) and BF-RhodoLED® in the Treatment of Superficial Basal Cell Carcinoma (sBCC) With Photodynamic Therapy (PDT). [NCT03573401]Phase 3186 participants (Anticipated)Interventional2018-09-25Active, not recruiting
Fluorescence-Guided Detection of Malignant Gliomas: A Dose Ranging Study Using 5-Aminolevulinic Acid (ALA) Induced Protoporphyrin (PpIX) in a Multicenter Phase II Clinical Trial [NCT00752323]Phase 273 participants (Actual)Interventional2009-12-08Completed
A Blinded, Randomized, Intra-individual, Vehicle-controlled and Multi-centre Study of Photodynamic Therapy With MAL Cream in Patients With Skin Type V or VI With Acne Vulgaris [NCT00673933]Phase 220 participants (Actual)Interventional2008-05-31Completed
A Randomized Placebo-controlled Clinical Trial of Topical Photodynamic Therapy With 5-aminolevulinic Acid for the Treatment of Actinic Keratosis [NCT02799030]Phase 2105 participants (Actual)Interventional2006-10-31Completed
Short Contact Protocols to Reduce Pain During Treatment of Actinic Keratoses With 10% ALA Gel Red-light Photodynamic Therapy (PDT) [NCT06027619]Phase 230 participants (Anticipated)Interventional2023-10-02Recruiting
Pilot Study for the Use of Photodynamic Therapy in the Treatment of Seborrheic Dermatitis [NCT03114111]Early Phase 112 participants (Actual)Interventional2017-01-31Completed
UCI 14-92 / HS#2015-1889: Phase IV Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses [NCT03327831]Phase 431 participants (Actual)Interventional2015-04-30Completed
A Laser Detection for Bladder Cancer by (Photodynamic) Spectra of Urine [NCT02101931]Phase 3100 participants (Actual)Interventional2014-03-31Completed
A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer [NCT05600322]Phase 3158 participants (Actual)Interventional2022-11-03Completed
Evaluation of the Feasibility of PD L 506 for Stereotactic Interstitial Photodynamic Therapy (iPDT) in Adult Patients With Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma [NCT03897491]Phase 220 participants (Anticipated)Interventional2021-09-03Recruiting
Thermo-mechanical Fractional Injury Enhances Skin Surface- and Epidermal- Protoporphyrin IX Fluorescence: Comparison of 5-aminolevulinic Acid in Cream and Gel Vehicles [NCT04221126]Phase 416 participants (Actual)Interventional2019-04-29Completed
Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas [NCT02755142]Phase 1/Phase 221 participants (Actual)Interventional2000-02-29Completed
A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up [NCT02666534]Phase 145 participants (Actual)Interventional2012-01-31Completed
Controlled Clinical Trial to Evaluate the Safety and Efficacy of Stereotactical Photodynamic Therapy With 5-aminolevulinic Acid (Gliolan®) in Recurrent Glioblastoma [NCT04469699]Phase 2106 participants (Anticipated)Interventional2021-04-12Recruiting
[NCT00711178]150 participants (Anticipated)Interventional2008-06-30Completed
Co-registered Fluorescence-Enhanced Resection of Brain Tumors Stage I: Correlation With MR and Biopsy [NCT00870779]Phase 1105 participants (Actual)Interventional2007-05-31Completed
A Phase 1 and 2 Study of 5-aminolevulinic Acid (5-ALA) to Enhance Visualisation and Resection of Malignant Glial Tumors of the Brain [NCT00977795]Phase 1/Phase 20 participants (Actual)Interventional2009-09-30Withdrawn(stopped due to PI moving to Southern Illinois University to start new protocol)
Comparative Intraindividual Study, About the Efficacy and Safety of Treatment of Actinic Keratoses With Photodynamic Therapy Between Acid Methyl Aminolevulinate Cream and Aminolevulinic Gel [NCT02647151]Phase 450 participants (Anticipated)Interventional2015-12-31Recruiting
Pain Relief During Photodynamic Therapy for Actinic Keratoses With a New Irradiation Protocol [NCT02644187]30 participants (Anticipated)Interventional2015-12-31Completed
Diagnostic Performance of Fluorescein as an Intraoperative Brain Tumor Biomarker: Correlation With Preoperative MR, ALA-induced PpIX Fluorescence, and Histopathology [NCT02691923]Phase 230 participants (Anticipated)Interventional2016-03-31Recruiting
Quantification of ALA-induced PpIX Fluorescence During Brain Tumor Resection [NCT02191488]Phase 1540 participants (Anticipated)Interventional2014-07-31Active, not recruiting
Modification of Extracorporeal Photopheresis Technology With 5-aminolevulinic Acid in Patients With Cutaneous T-cell Lymphoma or Chronic Graft-versus-host Disease - A Proof-of-concept Study [NCT03109353]Phase 1/Phase 27 participants (Actual)Interventional2017-09-20Completed
Topical 5-ALA-PDT With Blu-U Therapy Vs. Topical 5-ALA With Pulse Dye Laser In Treatine Recalcitrant Acne Vulgaris [NCT00814918]0 participants (Actual)Interventional2009-02-28Withdrawn
Investigation of the Effectiveness of Non-Coherent Blue Light in Intralesional Photodynamic of Basal Cell Carcinoma [NCT00747903]Phase 220 participants (Anticipated)Interventional2008-02-29Recruiting
Photodynamic Therapy for Prevention of Nonmelanoma Skin Cancer in Organ Transplant Recipients [NCT02751151]10 participants (Actual)Interventional2016-02-29Completed
Barrow 5-ALA Intraoperative Confocal Evaluation Trial [NCT01502280]Phase 3127 participants (Actual)Interventional2010-11-30Completed
An Exploratory, Open-label Study of Sequential Field-directed Treatment of Actinic Keratoses of the Face With Imiquimod 3.75% Cream Followed by Photodynamic Therapy [NCT01203878]Phase 421 participants (Actual)Interventional2010-09-30Terminated(stopped due to Unable to reach target enrollment of 60 subjects)
Photodynamic Therapy for Cutibacterium Acnes (C. Acnes) Decolonization of the Shoulder Dermis [NCT04636242]Phase 3120 participants (Anticipated)Interventional2019-08-22Enrolling by invitation
A Split-Face Clinical Trial of Conventional Photodynamic Therapy Versus Daylight Photodynamic Therapy for The Treatment of Acne Vulgaris [NCT04631250]15 participants (Actual)Interventional2018-11-01Completed
Tolerability and Efficacy of Daylight Aminolevulinic-acid-photodynamic Therapy (ALA-PDT) Compared With Conventional ALA-PDT for Treatment of Actinic Keratosis on the Face or Scalp [NCT03322293]Phase 124 participants (Actual)Interventional2017-12-01Completed
A Phase 3 Multicenter Study of Gleolan™ (Aminolevulinic Acid Hydrochloride) to Enhance Visualization of Tumor in Patients With Suspected Newly Diagnosed or Recurrent Epithelial Ovarian Cancer [NCT05804370]Phase 3170 participants (Anticipated)Interventional2023-07-31Not yet recruiting
Phase I/II Dose Escalation Trial of Radiodynamic Therapy (RDT) With 5-Aminolevulinic Acid in Patients With First Recurrence of Glioblastoma [NCT05590689]Phase 1/Phase 234 participants (Anticipated)Interventional2022-11-09Recruiting
A Randomized, Evaluator-Blinded, Parallel Group Comparison of PDT With Levulan Topical Solution + Blue Light vs Levulan Topical Solution Vehicle + Blue Light for the Treatment of AK and Reduction of New NMSC in Organ Transplant Recipients [NCT00865878]Phase 26 participants (Actual)Interventional2009-05-31Terminated(stopped due to Orphan Drug Designation for this indication not granted)
Photodynamic Therapy for Premalignant and Early Stage Head and Neck Tumors [NCT00978081]Phase 135 participants (Actual)Interventional2009-01-31Completed
A Combined Phase I/II Single Site Study to Determine the Safety and Efficacy of Photodynamic Therapy (PDT) Utilizing 5-aminolevulinic Acid (5-ALA) and PDT in the Treatment of Premalignant Oral and/or Oropharynx Lesions. [NCT00571974]Phase 1/Phase 229 participants (Actual)Interventional2007-01-31Completed
Photodynamic Therapy With Metil 5-aminolevulinate for Actinic Cheilitis - A Phase 2 Randomized Double-blind Placebo Controlled Clinical Trial [NCT03990636]Phase 240 participants (Anticipated)Interventional2019-10-17Not yet recruiting
Phase I Study of Photodynamic Therapy Using Pulsed Dye Laser and Oral Aminolevulinic Acid in Patients With Oral Leukoplakia [NCT00571558]Phase 115 participants (Actual)Interventional2008-03-31Terminated
OPTIC-III Prospective Non-Interventional Study To Optimize Photodynamic TUR-B In Clinical Practice [NCT02012036]400 participants (Actual)Observational2013-07-31Completed
A Pilot Clinical Trial To Reduce Side-Effects Of Photodynamic Therapy For The Treatment Of Moderate To Severe Acne [NCT01689935]Phase 135 participants (Actual)Interventional2009-11-30Completed
A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas [NCT04390802]40 participants (Anticipated)Observational2021-07-31Not yet recruiting
An Interventional, Non-randomized, Phase 1/2, Light Dose-escalation Study to Investigate the Safety and Feasibility of Intraoperative Photodynamic Therapy (PDT) With Pentalafen® Drug and Heliance®Solution Device in Male and Female Patients 18 to 69 Years [NCT05736406]Phase 1/Phase 212 participants (Anticipated)Interventional2024-01-31Not yet recruiting
Safety and Efficacy of Photodynamic Therapy With Aminolevulinic Acid 10% Topical Gel Activated by Red Light Versus Aminolevulinic Acid 20% Topical Solution Activated by Blue Light for the Treatment of Actinic Keratosis on the Upper Extremities: A Blinded [NCT05359419]Phase 420 participants (Anticipated)Interventional2022-05-15Not yet recruiting
A Pilot Study to Investigate the Use of Topical Levulan® With Vbeam® Laser for the Treatment of Actinic Keratoses [NCT00524485]12 participants (Actual)Interventional2005-05-31Terminated(stopped due to Withdrawn due to low accrual)
A Randomized, Evaluator-blinded, Bilateral Comparison of the Treatment of Facial Actinic Keratoses Using Combination Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Bl [NCT02622594]Phase 410 participants (Actual)Interventional2015-10-31Completed
Daylight Photodynamic Therapy for the Treatment of Actinic Keratoses in the Northeast United States [NCT02867722]0 participants (Actual)Interventional2020-12-31Withdrawn(stopped due to The PI decided to not proceed with the trial due to lack of funding.)
Photodynamic Therapy for Melanoma Precursor Lesion Lentigo Maligna Using 5-aminolevulinic Acid Nanoemulsion (BF-200 ALA) as a Light Sensitizing Cream [NCT02685592]Phase 410 participants (Actual)Interventional2016-02-29Completed
Efficacy and Safety of Painless 5-aminolevulinic Acid Photodynamic Therapy for the Treatment of Moderate and Severe Acne Vulgaris-- A Multi-center, Randomized Controlled Clinical Trial [NCT04167982]234 participants (Anticipated)Interventional2020-03-28Recruiting
Evaluation of Protoporphyrin Formation in Non-Melanoma Skin Cancers After Topical Application of 5-Aminolevulinic Acid: A Pilot Study [NCT00663910]Early Phase 118 participants (Actual)Interventional2008-03-31Terminated(stopped due to Of the 8 histologically proven tumors, detection of PpIX proved to be ambiguous.)
A Phase 1 and 2 Study of Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Malignant Glial Tumors of the Brain [NCT00671710]Phase 126 participants (Anticipated)Interventional2008-04-30Completed
A Pilot, Double-blind, Randomized, Parallel-group, Placebo-controlled, Exploratory Study to Assess the Safety and Efficacy of 5-aminolevulinic Acid Hydrochloride (5-ALA HCl) and Sodium Ferrous Citrate (SFC) Added on Artemisinin-based Combination Therapy ( [NCT04020653]Phase 20 participants (Actual)Interventional2019-09-06Withdrawn(stopped due to Considering the Thai FDA requirement, changes of Malaria cases in Thailand and EC recommendation, the decision to withdrawal the study was made.)
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis [NCT03013647]20 participants (Anticipated)Interventional2016-09-30Recruiting
Low-cost Enabling Technology for Image-guided Photodynamic Therapy (PDT) of Oral [NCT03638622]Phase 1/Phase 230 participants (Actual)Interventional2017-03-10Completed
Methyl Aminolevulinate (MAL) and Hexaminolevulinate (HAL) Photodynamic Therapy (PDT)of Cervical Intraepithelial Lesions (SIL) - a Double-blind Dose-finding Study [NCT00369018]Phase 1/Phase 296 participants (Anticipated)Interventional2006-08-31Completed
Treatment of Superficial Basal Cell Carcinoma by Topical Photodynamic Therapy With Fractionated 5-aminolevulinic Acid 20% Versus Two Stage Topical Photodynamic Therapy With Methylaminolevulinate [NCT01491711]Phase 4162 participants (Anticipated)Interventional2013-08-31Recruiting
Compassionate Use of Metvix® (Methyl Aminolevulinate) PDT in Subjects With Field Actinic Keratoses, Large/Multiple Superficial BCCs, or Bowen's Disease [NCT00535080]0 participants Expanded AccessNo longer available
A Pilot Study to Evaluate the Safety and Feasibility of Sonodynamic Therapy Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas. [NCT04845919]Phase 25 participants (Anticipated)Interventional2023-02-28Not yet recruiting
A Phase 2 Study of the Effect of Microneedle Lesion Preparation, Incubation Time and Light Power Density on Photodynamic Therapy With Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% + Blue Light for the Field Treatment of Actinic Ker [NCT02632110]Phase 2137 participants (Actual)Interventional2016-03-31Completed
A Randomized Controlled Blinded Multi-centre Study of Photodynamic Therapy With Methyl-aminolevulinate Comparing a Simplified Regime With the Approved Regime in Patients With Clinical Low-risk Superficial and Nodular Basal Cell Carcinoma. [NCT01482104]277 participants (Actual)Interventional2012-06-30Completed
Topical Photodynamic Therapy (PDT) With Levulan® Kerastick® for Benign Dermal Neurofibromas Phase II [NCT02728388]Phase 230 participants (Anticipated)Interventional2016-08-31Recruiting
Laser-Mediated Photodynamic Therapy of Acne Vulgaris and Rosacea [NCT00483145]0 participants Interventional2006-11-30Completed
Piezoelectric Drived Microneedling in Treating Refractory Skin Diseases: A Pilot Study [NCT05488860]20 participants (Anticipated)Interventional2022-07-30Recruiting
A Multicenter, Phase III, Randomised Study of Photodynamic Therapy With Metvix Cream 160 mg/g in Comparison With Cryotherapy in Patients With Primary Superficial Basal Cell Carcinoma [NCT00469417]Phase 3120 participants (Actual)Interventional1999-10-31Completed
A Randomized Phase II Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low-grade Cervical Intraepithelial Neoplasia (CIN1) [NCT00708942]Phase 283 participants (Actual)Interventional2009-01-31Terminated(stopped due to Slow recruitment, study stopped with only 13 of 70 patients included in second part of the study)
A Phase I/II Study of Neoadjuvant Photodynamic Immunomodulation for Colon Cancer [NCT01522677]Phase 1/Phase 20 participants (Actual)Interventional2012-08-31Withdrawn(stopped due to Slow accrual)
A Phase II Study of Photodynamic Therapy With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light Using Spot and Broad Area Application and Incubation Times of 1, 2 and 3 Hours for the Treatment of Multiple Actinic [NCT01475955]Phase 2235 participants (Actual)Interventional2011-12-31Completed
A Pilot Study of Short (1-2.5 h), Medium (4-6 h) and Long (18-24 h) Applications of 20% Topical ALA-PDT for Photodynamic Therapy of Cutaneous T and B Cell Lymphomas and Cutaneous Infiltrates of Early CLL [NCT00054171]Phase 21 participants (Actual)Interventional1999-02-28Completed
Non-interventional Study Investigating Photodynamic Therapy With Artificial Daylight Under Routine Clinical Conditions in Patients With Actinic Keratosis (ArtLight) [NCT05725213]350 participants (Anticipated)Observational2022-11-01Recruiting
A Randomized, Double-blind, Phase III, Multi-center Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) Versus Placebo in the Field-directed Treatment of Mild to Moderate Actinic Keratosis With Photodynamic Therapy (PDT) When Using the BF-Rh [NCT01966120]Phase 387 participants (Actual)Interventional2013-10-31Completed
Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery [NCT01798771]108 participants (Anticipated)Interventional2013-03-31Not yet recruiting
A Randomized Controlled Trial Evaluating 5-aminolevulinic Acid Photodynamic Therapy With Different Incubation Times for the Treatment of Actinic Keratosis [NCT03066843]60 participants (Anticipated)Interventional2017-03-01Active, not recruiting
[NCT00594425]Phase 2150 participants (Actual)Interventional2007-02-28Completed
A Prospective, Open, Comparative, Within Patient Controlled Multicenter Phase 3 Study of Blue Light Cystoscopy With Cysview and White Light Cystoscopy Using KARL STORZ D-Light C PDD Flexible Videoscope System in Detection of Bladder Cancer in Patients Wit [NCT02560584]Phase 3304 participants (Actual)Interventional2015-10-01Completed
The Role of 5-Aminolevulinic Acid Fluorescence-Guided Surgery in Head and Neck Cancers: a Pilot Trial [NCT05101798]Phase 226 participants (Anticipated)Interventional2021-09-14Recruiting
Adverse Effects of ALA-PDT for the Treatment of Moderate to Severe Acne [NCT04709289]40 participants (Actual)Interventional2020-01-01Completed
Improving Fluorescence-guided Brain Tumour Surgery With Ultra-high Sensitivity Imaging [NCT04556929]20 participants (Anticipated)Interventional2021-03-19Recruiting
Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection [NCT00241670]Phase 3415 participants (Actual)Interventional1999-10-31Completed
A Multicenter, Double Blind, Vehicle-Controlled, Randomized Study of Photodynamic Therapy (PDT) With Metvix 160 Mg/g Cream and Aktilite CL128 LED Light in Patients With Multiple Actinic Keratosis on the Face and/or Scalp [NCT00306800]Phase 380 participants (Anticipated)Interventional2007-09-30Completed
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas [NCT01502605]Phase 16 participants (Actual)Interventional2012-09-30Terminated(stopped due to PI leaving institution)
Supplement 5-ALA And Sleep And Mood Study [NCT01508741]85 participants (Actual)Interventional2012-01-31Completed
"A Multicenter, Open Phase II Study to Assess the Effect and Safety of Low Dose Photodynamic Therapy in Patients With Moderate to Severe Active Distal Ulcerative Colitis" [NCT01697670]Phase 17 participants (Anticipated)Interventional2012-09-30Recruiting
Photodynamic Therapy (PDT) With Levulan and Blue Light for the Treatment of Actinic Cheilitis [NCT02409732]Phase 424 participants (Actual)Interventional2015-04-30Completed
A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions [NCT02281136]Phase 229 participants (Actual)Interventional2014-12-31Completed
A Multicenter Phase II Study of 5-Aminolevulinic Acid (ALA) to Enhance Visualization and Resection of Newly Diagnosed or Recurrent Malignant Gliomas [NCT01445691]Phase 20 participants (Actual)Interventional2015-11-30Withdrawn
Pilot Trial Comparing Two Different Wavelengths of Light (Blue Versus Red) During Levulan™-Based Photodynamic Therapy of Basal Cell Carcinoma in Patients With Basal Cell Nevus Syndrome [NCT02157623]3 participants (Actual)Interventional2016-02-01Completed
Conventional Photodynamic Therapy vs. Painless Photodynamic Therapy for Actinic Keratosis#a Randomized, Open-label Trial [NCT04396184]10 participants (Anticipated)Interventional2020-05-01Recruiting
Prevalence of Acute Hepatic Porphyria in Population With Suggestive Clinical Picture [NCT04923516]500 participants (Anticipated)Observational2021-06-30Not yet recruiting
Phase III Clinical Trial Evaluating the Efficacy of 5-aminolevulinic Acid (5-ALA HCl) Fluorescence-guided Microsurgery Versus Conventional White Light Microsurgical Resection in Patients With Malignant Gliomas (WHO Grade 3/4) [NCT06160492]Phase 3144 participants (Anticipated)Interventional2024-02-29Not yet recruiting
A Pilot Study of Photodynamic Therapy in Refractory Plaques and Tumors of Mycosis Fungoides [NCT03281811]Early Phase 111 participants (Actual)Interventional2017-11-13Completed
"An Open Multicenter, Phase III Study of Photodynamic Therapy With Metvix® Cream 160 mg/g in Patients With High Risk Basal Cell Carcinoma" [NCT00473343]Phase 3102 participants (Actual)Interventional2000-09-30Completed
A Randomized, Double-blind, Cross-over Study to Assess Efficacy of 5-Aminolevulinic Acid in Type 2 Diabetic Patients on Medication. [NCT01610778]35 participants (Anticipated)Interventional2012-05-31Completed
Clinical Safety Study on 5-Aminolevulinic Acid (5-ALA) in Children and Adolescents With Supratentorial Brain Tumors [NCT04738162]Phase 280 participants (Anticipated)Interventional2020-09-25Recruiting
A Phase II Randomized, Open Label Trial Comparing the Effects of Intermittent Vismodegib Versus PDT on the Maintenance of Benefit Following 7 Months of Continuous Vismodegib Treatment in Patients With Multiple Basal Cell Carcinomas [NCT01556009]Phase 224 participants (Actual)Interventional2012-04-30Completed
A Phase II Trial of 4-5 Hour and 18-24 Hour Applications of 20% Topical ALA for Photodynamic Therapy of Cutaneous Carcinomas and Actinic Keratoses [NCT00002975]Phase 2180 participants (Actual)Interventional1997-02-28Completed
Cutaneous Absorption and Intralesional Penetration of Topical Amino-Levulinic Acid in Basal Cell Carcinoma and Squamous Cell Carcinoma as Measured by In Situ Fluorescence and Intensified Video Fluorescence Microscopy [NCT00002963]Phase 20 participants Interventional1993-11-30Completed
Intraoperative Sonographically Guided Versus 5-Aminolevulinic Acid Fluorescence Guided Resection of Gliomas and Brain Metastases Enhancing Contrast Agent in Magnetic Resonance Imaging: a Randomised, Controlled, Noninferiority Trial [NCT05475522]134 participants (Anticipated)Interventional2022-09-01Recruiting
A Pharmacokinetic Study of Levulan Kerastick (Aminolevulinic Acid HCl) for Topical Solution, 20% Under Maximal Use Conditions [NCT02628236]Phase 214 participants (Actual)Interventional2016-02-29Completed
Treatment of AKs With Daylight-PDT: Comparing Two Photosensitizers (BF-200 ALA and MAL) [NCT01893203]Phase 414 participants (Actual)Interventional2013-08-31Completed
Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses. [NCT01475071]Phase 3100 participants (Actual)Interventional2012-03-31Completed
A Phase II Study of Photodynamic Therapy (PDT)With LEVULAN® Topical Solution + Blue Light Versus LEVULAN® Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities [NCT01458587]Phase 270 participants (Actual)Interventional2011-11-30Completed
A Randomized, Evaluator-blinded, Parallel Group Light Dose Ranging Study of Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Levulan Topical Solution Vehicle + Blue Light on Moderate to Severe Facial Acne Vulgaris [NCT00706433]Phase 2266 participants (Actual)Interventional2007-03-31Completed
Long-term Efficacy of Ablative Fractional Laser-assisted Photodynamic Therapy for Treatment of Lower Extremity Bowen's Disease: A Prospective, Randomized, Controlled Trial With 5-year Follow up [NCT03320447]Phase 160 participants (Actual)Interventional2011-10-30Completed
Daylight Mediated Photodynamic Therapy for Actinic Keratoses: a Multicentre Study Comparing Two Photosensitizers (BF-200 ALA Versus MAL) [NCT02464709]Phase 472 participants (Actual)Interventional2015-06-30Completed
Blue Light Photodynamic Therapy Treatment for Distal and Lateral Subungual Toenail Onychomycosis [NCT03022903]2 participants (Actual)Interventional2015-09-30Completed
Cyclic PDT for the Prevention of Actinic Keratosis and Non Melanoma Skin Cancer in Solid Organ Transplant Recipients [NCT03110159]Phase 1/Phase 220 participants (Anticipated)Interventional2017-08-29Recruiting
Safety and Efficacy of Carbon Dioxide(CO2)Fractional Laser Combined With Photodynamic Therapy in the Treatment of Female Vulvar Lichen Sclerosus [NCT05228483]134 participants (Anticipated)Interventional2021-11-23Recruiting
Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitizers: Hexylaminolevulinate and Aminolevulinic Acid Nano Emulsion Versus Methylaminolevulinate [NCT02367547]Phase 1/Phase 2117 participants (Actual)Interventional2015-03-31Active, not recruiting
A Phase 2 Comparative Study of 5-Aminolevulinic Acid (5-ALA) and Intraoperative MRI (iMRI) to Enhance Completeness of Resection of Glioblastoma [NCT01575275]Phase 28 participants (Actual)Interventional2012-05-31Terminated(stopped due to Drugs unavailable)
Photodynamic Therapy for Treatment of Cutaneous Squamous Cell Carcinoma in Situ [NCT03025724]40 participants (Anticipated)Interventional2017-01-31Not yet recruiting
Photodynamic Therapy for Benign Dermal Neurofibromas Using Levulan Kerastick For Topical Solution, Plus Illumination With Red Light [NCT01682811]Phase 120 participants (Actual)Interventional2012-03-12Completed
A PHASE 2, SINGLE CENTRE, SINGLE ARM STUDY TO DETERMINE THE EFFICACY AND SAFETY OF 5- ALA POHOTODYNAMIC THERAPY AS ADJUVANT THERAPY AFTER SURGICAL DISSECTION IN PATIENTS WITH DESMOID TUMORS. [NCT01898416]Phase 2140 participants (Anticipated)Interventional2013-06-30Recruiting
A Randomized, Double-blind, Vehicle-controlled, Multicenter Phase III Study to Evaluate the Safety, Tolerability, and Efficacy of BF-200 ALA (Ameluz®) in the Field-directed Treatment of Actinic Keratosis on the Extremities and Neck/Trunk With Photodynamic [NCT05662202]Phase 3165 participants (Anticipated)Interventional2022-12-12Active, not recruiting
Daylight-mediated Photodynamic Therapy of Actinic Keratoses: a Randomized, Double-blinded Pilot Study Comparing Topical 0.2% Hexylaminolaevulinate With 16% Methylaminolaevulinate [NCT02149342]Phase 1/Phase 214 participants (Actual)Interventional2014-05-31Completed
Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid [NCT04164849]Phase 1/Phase 210 participants (Anticipated)Interventional2019-11-22Recruiting
Alteration of the Immune Microenvironment in Basal Cell Carcinoma (BCC) Following Photodynamic Therapy (PDT) [NCT05020912]Phase 228 participants (Anticipated)Interventional2021-12-13Recruiting
A Phase 1 Multi-center Clinical Trial Evaluating the Safety and Tolerability of 5-aminolevulinic Acid (5-ALA) Combined With CV01 Delivery of Ultrasound for Sonodynamic Therapy(SDT) in Patients With Recurrent High Grade Glioma (HGG) [NCT05362409]Phase 148 participants (Anticipated)Interventional2022-06-29Recruiting
A RANDOMIZED, VEHICLE-CONTROLLED PHASE 3 STUDY TO PROVE THE SAFETY AND EFFICACY OF LEVULAN KERASTICK (AMINOLEVULINIC ACID HCl) FOR TOPICAL SOLUTION, 20% AND 10 J/CM2 OF BLUE LIGHT DELIVERED AT 10 MW/CM2 OR 20 MW/CM2 BY A NEW LIGHT SOURCE FOR THE TREATMENT [NCT03024060]Phase 30 participants (Actual)Interventional2017-03-31Withdrawn(stopped due to Study withdrawn due to corporate business decision)
A Phase 2 Study Comparing the Occurrence of Actinic Keratoses on the Face in High-Risk Individuals After Cryotherapy + Photodynamic Therapy With Levulan Topical Solution + Blue Light Versus Cryotherapy + Vehicle Topical Solution + Blue Light [NCT02239679]Phase 2166 participants (Actual)Interventional2014-09-30Completed
The Use of Microneedles in Photodynamic Therapy [NCT01812837]51 participants (Actual)Interventional2012-07-31Completed
A Phase 1 and 2 Study of 5-aminolevulinic Acid (5-ALA) to Enhance Visualisation and Resection of Malignant Glial Tumors of the Brain [NCT01128218]Phase 1/Phase 233 participants (Actual)Interventional2011-03-31Completed
Simultaneous Incubation/Illumination Versus Short Aminolevulinate Preincubation for Painless Photodynamic Therapy of Actinic Keratoses [NCT02124733]Phase 323 participants (Actual)Interventional2014-04-30Completed
The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy [NCT02594644]32 participants (Actual)Interventional2014-11-06Completed
A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities [NCT02137785]Phase 3269 participants (Actual)Interventional2014-05-31Completed
A Randomized, Observer Blind, Multinational Phase III Study to Evaluate the Safety and Efficacy of BF-200 ALA (Ameluz®) in Comparison to Metvix® in the Treatment of Non-aggressive Basal Cell Carcinoma (BCC) With Photodynamic Therapy (PDT) [NCT02144077]Phase 3281 participants (Actual)Interventional2014-01-28Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00473343 (6) [back to overview]Recurrence Rate in Complete Clearance Group
NCT00473343 (6) [back to overview]Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle
NCT00473343 (6) [back to overview]Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle
NCT00473343 (6) [back to overview]Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle
NCT00473343 (6) [back to overview]Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle
NCT00473343 (6) [back to overview]Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle
NCT00571974 (2) [back to overview]The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR).
NCT00571974 (2) [back to overview]Maximum Tolerated Dose
NCT00594425 (34) [back to overview]Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Erythema After Third Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Erythema After Second Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Erythema After First Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Erythema After First Treatment
NCT00594425 (34) [back to overview]Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
NCT00594425 (34) [back to overview]Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
NCT00594425 (34) [back to overview]Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment
NCT00594425 (34) [back to overview]Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
NCT00594425 (34) [back to overview]Proportion of Patients With Severe Erythema After Second Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Severe Erythema After Fourth Treatment
NCT00594425 (34) [back to overview]Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.
NCT00594425 (34) [back to overview]Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain
NCT00594425 (34) [back to overview]Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
NCT00594425 (34) [back to overview]Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
NCT00594425 (34) [back to overview]Proportion of Patients With Severe Erythema After First Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Severe Erythema 7 Days After First Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Severe Erythema 2 Days After First Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment
NCT00594425 (34) [back to overview]Proportion of Patients With Severe Erythema After Third Treatment
NCT00594425 (34) [back to overview]Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
NCT00594425 (34) [back to overview]Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment
NCT00594425 (34) [back to overview]Percent Reduction in Total Lesion Counts From Baseline
NCT00594425 (34) [back to overview]The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment
NCT00673933 (6) [back to overview]Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment
NCT00673933 (6) [back to overview]Erythema Score (Mild and Moderate)Immediately After Second Treatment
NCT00673933 (6) [back to overview]Erythema Score (Mild and Moderate)Immediately After First PDT
NCT00673933 (6) [back to overview]Change in Noninflammatory Lesion Counts From Baseline
NCT00673933 (6) [back to overview]Change in Inflammatory Lesion Counts From Baseline
NCT00673933 (6) [back to overview]Erythema Score (Mild and Moderate)1 Day After First Treatment
NCT00706433 (77) [back to overview]Hypopigmentation at Visit 3 (Week 3)
NCT00706433 (77) [back to overview]Hypopigmentation at Visit 10 (6 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Hypopigmentation 48 Hours Post PDT #1
NCT00706433 (77) [back to overview]Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Hyperpigmentation at Visit 7 (Week 9)
NCT00706433 (77) [back to overview]Hyperpigmentation at Visit 5 (Week 6)
NCT00706433 (77) [back to overview]Hyperpigmentation at Visit 3 (Week 3)
NCT00706433 (77) [back to overview]Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Hyperpigmentation 48 Hours After PDT #1
NCT00706433 (77) [back to overview]Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)
NCT00706433 (77) [back to overview]Erythema at Visit 7 (Week 9 - Pre Light Treatment)
NCT00706433 (77) [back to overview]Erythema at Visit 7 (Week 9 - Post Light Treatment)
NCT00706433 (77) [back to overview]Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)
NCT00706433 (77) [back to overview]Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)
NCT00706433 (77) [back to overview]Erythema at Visit 5 (Week 6 - Post Light Treatment)
NCT00706433 (77) [back to overview]Erythema at Visit 3 (Week 3 - Pre-light)
NCT00706433 (77) [back to overview]Erythema at Visit 3 (Week 3 - Pre Study Drug Application)
NCT00706433 (77) [back to overview]Erythema at Visit 3 (Week 3 - Post Light Treatment)
NCT00706433 (77) [back to overview]Erythema at Baseline (Pre-light)
NCT00706433 (77) [back to overview]Erythema at Baseline - Post Light Treatment
NCT00706433 (77) [back to overview]Erythema 6 Weeks After Final PDT
NCT00706433 (77) [back to overview]Erythema 48 Hours After PDT #1
NCT00706433 (77) [back to overview]Erythema 3 Weeks After Final PDT
NCT00706433 (77) [back to overview]Edema at Visit 7 (Week 9 - Prior to Light Treatment)
NCT00706433 (77) [back to overview]Edema at Visit 7 (Week 9 - Post Light Treatment)
NCT00706433 (77) [back to overview]Edema at Visit 7 (Week 9 - Before Study Drug Application)
NCT00706433 (77) [back to overview]Edema at Visit 5 (Week 6 - Pre Light Treatment)
NCT00706433 (77) [back to overview]Edema at Visit 5 (Week 6 - Post Light Treatment)
NCT00706433 (77) [back to overview]Edema at Visit 5 (Week 6 - Before Study Drug Application)
NCT00706433 (77) [back to overview]Edema at Visit 3 (Week 3 - Post Light Treatment)
NCT00706433 (77) [back to overview]Edema at Visit 3 (Week 3 - Before Study Drug Application)
NCT00706433 (77) [back to overview]Edema at Visit 3 (Week 3 - Before Light Treatment)
NCT00706433 (77) [back to overview]Edema at Baseline - Pre Light Treatment
NCT00706433 (77) [back to overview]Edema at Baseline - Post Light Treatment
NCT00706433 (77) [back to overview]Edema 6 Weeks After Final PDT
NCT00706433 (77) [back to overview]Edema 48 Hours After PDT #1
NCT00706433 (77) [back to overview]Edema 3 Weeks After Final PDT
NCT00706433 (77) [back to overview]Percent Change in Inflammatory Lesion Counts Relative to Baseline
NCT00706433 (77) [back to overview]Percent Change in Inflammatory Lesion Counts Relative to Baseline
NCT00706433 (77) [back to overview]Change in Inflammatory Lesion Counts Relative to Baseline
NCT00706433 (77) [back to overview]Change in Inflammatory Lesion Counts Relative to Baseline
NCT00706433 (77) [back to overview]Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Oozing/Vesiculation/Crusting at Visit 7 (Week 9)
NCT00706433 (77) [back to overview]Oozing/Vesiculation/Crusting at Visit 5 (Week 6)
NCT00706433 (77) [back to overview]Oozing/Vesiculation/Crusting at Visit 3 (Week 3)
NCT00706433 (77) [back to overview]Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Oozing/Vesiculation/Crusting 48 Hours After PDT #1
NCT00706433 (77) [back to overview]Investigator Global Assessment of Acne Severity Successes
NCT00706433 (77) [back to overview]Investigator Global Assessment of Acne Severity Successes
NCT00706433 (77) [back to overview]Hypopigmentation at Visit 9 (3 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Hypopigmentation at Visit 7 (Week 9)
NCT00706433 (77) [back to overview]Hypopigmentation at Visit 5 (Week 6)
NCT00706433 (77) [back to overview]Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Scaling and Dryness 48 Hours After PDT #1
NCT00706433 (77) [back to overview]Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Scaling and Dryness at Visit 3 (Week 3)
NCT00706433 (77) [back to overview]Scaling and Dryness at Visit 5 (Week 6)
NCT00706433 (77) [back to overview]Scaling and Dryness at Visit 7 (Week 9)
NCT00706433 (77) [back to overview]Stinging/Burning 48 Hours Post PDT #1
NCT00706433 (77) [back to overview]Stinging/Burning at Baseline - Before Light Treatment
NCT00706433 (77) [back to overview]Stinging/Burning at Baseline - During Light
NCT00706433 (77) [back to overview]Stinging/Burning at Baseline - Post Light Treatment
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 10 (6 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)
NCT00706433 (77) [back to overview]Stinging/Burning at Visit 9 (3 Weeks After Final PDT)
NCT00706433 (77) [back to overview]Subject Satisfaction Score
NCT00708942 (3) [back to overview]Eradication of HPV
NCT00708942 (3) [back to overview]Complete Response Rate
NCT00708942 (3) [back to overview]Incidence of Patients With Adverse Events
NCT01128218 (3) [back to overview]Determine the Sensitivity, Specificity, and Positive Predictive Value of 5-ALA Mediated Fluorescence for Malignant Glioma Tissue in the Brain.
NCT01128218 (3) [back to overview]Establish a Safe Dose for Oral 5-ALA Administration
NCT01128218 (3) [back to overview]Assess 5-ALA's Resulting Fluorescence for Distinguishing Tumor Within the Brain
NCT01203878 (3) [back to overview]Actinic Keratosis Count
NCT01203878 (3) [back to overview]Cosmetic Appearance
NCT01203878 (3) [back to overview]Complete Clearance
NCT01310868 (3) [back to overview]Safety, Tolerability, and Feasibility of Combination Intra-operative 5-ALA and Gliadel Wafers Prior to Adjuvant Radiotherapy Plus Temozolomide
NCT01310868 (3) [back to overview]Time to Clinical Progression
NCT01310868 (3) [back to overview]Survival at 24 Months
NCT01458587 (39) [back to overview]Hyperpigmentation at Baseline
NCT01458587 (39) [back to overview]Erythema Post-Light Treatment
NCT01458587 (39) [back to overview]Erythema at Visit 5
NCT01458587 (39) [back to overview]Partial Clearance Rate
NCT01458587 (39) [back to overview]Partial Clearance Rate
NCT01458587 (39) [back to overview]Lesion Clearance Rate
NCT01458587 (39) [back to overview]Lesion Clearance Rate
NCT01458587 (39) [back to overview]Complete Clearance Rate
NCT01458587 (39) [back to overview]Complete Clearance Rate
NCT01458587 (39) [back to overview]Erythema at Visit 3
NCT01458587 (39) [back to overview]Erythema at Baseline
NCT01458587 (39) [back to overview]Edema Post-Light Treatment
NCT01458587 (39) [back to overview]Edema at Visit 5
NCT01458587 (39) [back to overview]Edema at Visit 4
NCT01458587 (39) [back to overview]Erythema at Visit 4
NCT01458587 (39) [back to overview]Stinging/Burning at Visit 4
NCT01458587 (39) [back to overview]Scaling and Dryness at Visit 3
NCT01458587 (39) [back to overview]Edema at Baseline
NCT01458587 (39) [back to overview]Edema at Visit 3
NCT01458587 (39) [back to overview]Stinging/Burning at Visit 5
NCT01458587 (39) [back to overview]Hyperpigmentation at Visit 3
NCT01458587 (39) [back to overview]Stinging/Burning During Light Treatment
NCT01458587 (39) [back to overview]Hyperpigmentation at Visit 5
NCT01458587 (39) [back to overview]Hypopigmentation at Baseline
NCT01458587 (39) [back to overview]Hypopigmentation at Visit 3
NCT01458587 (39) [back to overview]Hypopigmentation at Visit 4
NCT01458587 (39) [back to overview]Stinging/Burning Post Light Treatment
NCT01458587 (39) [back to overview]OOZING/VESICULATION/CRUSTING at Baseline
NCT01458587 (39) [back to overview]OOZING/VESICULATION/CRUSTING at Visit 3
NCT01458587 (39) [back to overview]OOZING/VESICULATION/CRUSTING at Visit 4
NCT01458587 (39) [back to overview]OOZING/VESICULATION/CRUSTING at Visit 5
NCT01458587 (39) [back to overview]Scaling and Dryness at Baseline
NCT01458587 (39) [back to overview]Hypopigmentation at Visit 5
NCT01458587 (39) [back to overview]Scaling and Dryness at Visit 5
NCT01458587 (39) [back to overview]Stinging/Burning at Baseline
NCT01458587 (39) [back to overview]Stinging/Burning at Visit 3
NCT01458587 (39) [back to overview]Subject Satisfaction Score
NCT01458587 (39) [back to overview]Hyperpigmentation at Visit 4
NCT01458587 (39) [back to overview]Scaling and Dryness at Visit 4
NCT01475071 (2) [back to overview]Lesion Response
NCT01475071 (2) [back to overview]Pain Score
NCT01475955 (70) [back to overview]AK Clearance Rate
NCT01475955 (70) [back to overview]AK Clearance Rate
NCT01475955 (70) [back to overview]AK Clearance Rate
NCT01475955 (70) [back to overview]Complete Clearance Rate
NCT01475955 (70) [back to overview]Complete Clearance Rate
NCT01475955 (70) [back to overview]Complete Clearance Rate
NCT01475955 (70) [back to overview]Complete Clearance Rate
NCT01475955 (70) [back to overview]Partial Clearance Rate
NCT01475955 (70) [back to overview]Stinging/Burning at Visit 2
NCT01475955 (70) [back to overview]Partial Clearance Rate
NCT01475955 (70) [back to overview]Partial Clearance Rate
NCT01475955 (70) [back to overview]Partial Clearance Rate
NCT01475955 (70) [back to overview]Edema at Baseline
NCT01475955 (70) [back to overview]Edema at Visit 2
NCT01475955 (70) [back to overview]Edema at Visit 4
NCT01475955 (70) [back to overview]Edema at Visit 5 (Pre-drug)
NCT01475955 (70) [back to overview]Edema at Week 12
NCT01475955 (70) [back to overview]Edema Post PDT #2
NCT01475955 (70) [back to overview]Edema Post-Light Treatment
NCT01475955 (70) [back to overview]Erythema at Baseline
NCT01475955 (70) [back to overview]Erythema at Visit 2
NCT01475955 (70) [back to overview]Erythema at Visit 3
NCT01475955 (70) [back to overview]Erythema at Visit 4
NCT01475955 (70) [back to overview]Erythema at Visit 5 (Post-light)
NCT01475955 (70) [back to overview]Erythema at Visit 5 (Pre-drug)
NCT01475955 (70) [back to overview]Erythema at Visit 6
NCT01475955 (70) [back to overview]Erythema at Visit 7
NCT01475955 (70) [back to overview]Erythema Post-Light Treatment
NCT01475955 (70) [back to overview]Hyperpigmentation at Baseline
NCT01475955 (70) [back to overview]Hyperpigmentation at Visit 2
NCT01475955 (70) [back to overview]Hyperpigmentation at Visit 3
NCT01475955 (70) [back to overview]Hyperpigmentation at Visit 4
NCT01475955 (70) [back to overview]Hyperpigmentation at Visit 5
NCT01475955 (70) [back to overview]Hyperpigmentation at Visit 6
NCT01475955 (70) [back to overview]Hyperpigmentation at Visit 7
NCT01475955 (70) [back to overview]Hypopigmentation at Baseline
NCT01475955 (70) [back to overview]Hypopigmentation at Visit 2
NCT01475955 (70) [back to overview]Hypopigmentation at Visit 3
NCT01475955 (70) [back to overview]Hypopigmentation at Visit 4
NCT01475955 (70) [back to overview]Hypopigmentation at Visit 5
NCT01475955 (70) [back to overview]Hypopigmentation at Visit 6
NCT01475955 (70) [back to overview]Hypopigmentation at Visit 7
NCT01475955 (70) [back to overview]Oozing/Vesiculation/Crusting at Baseline
NCT01475955 (70) [back to overview]Oozing/Vesiculation/Crusting at Visit 2
NCT01475955 (70) [back to overview]Oozing/Vesiculation/Crusting at Visit 3
NCT01475955 (70) [back to overview]Oozing/Vesiculation/Crusting at Visit 4
NCT01475955 (70) [back to overview]Oozing/Vesiculation/Crusting at Visit 5
NCT01475955 (70) [back to overview]Oozing/Vesiculation/Crusting at Visit 6
NCT01475955 (70) [back to overview]Oozing/Vesiculation/Crusting at Visit 7
NCT01475955 (70) [back to overview]Scaling and Dryness at Baseline
NCT01475955 (70) [back to overview]Scaling and Dryness at Visit 2
NCT01475955 (70) [back to overview]Scaling and Dryness at Visit 3
NCT01475955 (70) [back to overview]Scaling and Dryness at Visit 4
NCT01475955 (70) [back to overview]Scaling and Dryness at Visit 5
NCT01475955 (70) [back to overview]Scaling and Dryness at Visit 6
NCT01475955 (70) [back to overview]Scaling and Dryness at Visit 7
NCT01475955 (70) [back to overview]Stinging/Burning at Baseline
NCT01475955 (70) [back to overview]Edema at Week 24
NCT01475955 (70) [back to overview]Stinging/Burning at Visit 3
NCT01475955 (70) [back to overview]Stinging/Burning at Visit 4
NCT01475955 (70) [back to overview]Stinging/Burning at Visit 5 (Pre-drug)
NCT01475955 (70) [back to overview]Stinging/Burning at Visit 5 During PDT#2
NCT01475955 (70) [back to overview]Stinging/Burning at Visit 5 Post PDT#2
NCT01475955 (70) [back to overview]Stinging/Burning at Visit 6
NCT01475955 (70) [back to overview]Stinging/Burning at Visit 7
NCT01475955 (70) [back to overview]Stinging/Burning During Light Treatment
NCT01475955 (70) [back to overview]Stinging/Burning Post Light-Treatment
NCT01475955 (70) [back to overview]Subject Satisfaction Score
NCT01475955 (70) [back to overview]Edema at Visit 3
NCT01475955 (70) [back to overview]AK Clearance Rate
NCT01575275 (2) [back to overview]Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid
NCT01575275 (2) [back to overview]Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index
NCT01682811 (5) [back to overview]Part 1: Optimal Occlusion Time
NCT01682811 (5) [back to overview]Part 1: Photosensitizer Uptake and Conversion to Protoporphyrin IX
NCT01682811 (5) [back to overview]Part 2: Efficacy - Lesion Area Growth Rate
NCT01682811 (5) [back to overview]Part 2: Maximum Tolerated Dose (MTD) of 633 nm Red Light
NCT01682811 (5) [back to overview]TUNEL Assay.
NCT01812837 (1) [back to overview]Actinic Keratoses Reduction Percent
NCT01893203 (4) [back to overview]Histological Lesion Clearance
NCT01893203 (4) [back to overview]Pain
NCT01893203 (4) [back to overview]Clinical Lesion Clearance
NCT01893203 (4) [back to overview]Adverse Reactions
NCT01966120 (15) [back to overview]Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3
NCT01966120 (15) [back to overview]Patient Recurrence Rate in Follow-up (Cumulative)
NCT01966120 (15) [back to overview]Patients' Satisfaction in Follow-up (12 Months)
NCT01966120 (15) [back to overview]Patients' Satisfaction in Follow-up (6 Months)
NCT01966120 (15) [back to overview]Skin Quality in Follow-up (12 Months)
NCT01966120 (15) [back to overview]Skin Quality in Follow-up (6 Months)
NCT01966120 (15) [back to overview]Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3
NCT01966120 (15) [back to overview]Change of Total Lesion Area 12 Weeks After Last PDT
NCT01966120 (15) [back to overview]Lesion Complete Response 12 Weeks After Last PDT
NCT01966120 (15) [back to overview]Overall Patient Complete Response 12 Weeks After the Last PDT (PP)
NCT01966120 (15) [back to overview]Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)
NCT01966120 (15) [back to overview]Patient Complete Response 12 Weeks After PDT 1
NCT01966120 (15) [back to overview]Patient Histopathological Confirmed Response Rate
NCT01966120 (15) [back to overview]Patient Partial Response 12 Weeks After Last PDT
NCT01966120 (15) [back to overview]Lesion Recurrence Rate in Follow-up (Cumulative)
NCT02075671 (5) [back to overview]Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)
NCT02075671 (5) [back to overview]Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA)
NCT02075671 (5) [back to overview]Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC)
NCT02075671 (5) [back to overview]Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale
NCT02075671 (5) [back to overview]Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale
NCT02137785 (51) [back to overview]AK Clearance Rate
NCT02137785 (51) [back to overview]AK Clearance Rate
NCT02137785 (51) [back to overview]Complete Clearance Rate
NCT02137785 (51) [back to overview]Complete Clearance Rate
NCT02137785 (51) [back to overview]Edema
NCT02137785 (51) [back to overview]Edema
NCT02137785 (51) [back to overview]Edema
NCT02137785 (51) [back to overview]Edema
NCT02137785 (51) [back to overview]Edema
NCT02137785 (51) [back to overview]Edema
NCT02137785 (51) [back to overview]Edema
NCT02137785 (51) [back to overview]Erythema
NCT02137785 (51) [back to overview]Erythema
NCT02137785 (51) [back to overview]Erythema
NCT02137785 (51) [back to overview]Erythema
NCT02137785 (51) [back to overview]Erythema
NCT02137785 (51) [back to overview]Erythema
NCT02137785 (51) [back to overview]Erythema
NCT02137785 (51) [back to overview]Hyperpigmentation
NCT02137785 (51) [back to overview]Hyperpigmentation
NCT02137785 (51) [back to overview]Hyperpigmentation
NCT02137785 (51) [back to overview]Hyperpigmentation
NCT02137785 (51) [back to overview]Hyperpigmentation
NCT02137785 (51) [back to overview]Hyperpigmentation
NCT02137785 (51) [back to overview]Hypopigmentation
NCT02137785 (51) [back to overview]Hypopigmentation
NCT02137785 (51) [back to overview]Hypopigmentation
NCT02137785 (51) [back to overview]Hypopigmentation
NCT02137785 (51) [back to overview]Hypopigmentation
NCT02137785 (51) [back to overview]Hypopigmentation
NCT02137785 (51) [back to overview]Oozing/Vesiculation/Crusting
NCT02137785 (51) [back to overview]Oozing/Vesiculation/Crusting
NCT02137785 (51) [back to overview]Oozing/Vesiculation/Crusting
NCT02137785 (51) [back to overview]Oozing/Vesiculation/Crusting
NCT02137785 (51) [back to overview]Oozing/Vesiculation/Crusting
NCT02137785 (51) [back to overview]Oozing/Vesiculation/Crusting
NCT02137785 (51) [back to overview]Scaling & Dryness
NCT02137785 (51) [back to overview]Scaling & Dryness
NCT02137785 (51) [back to overview]Scaling & Dryness
NCT02137785 (51) [back to overview]Scaling & Dryness
NCT02137785 (51) [back to overview]Scaling & Dryness
NCT02137785 (51) [back to overview]Scaling & Dryness
NCT02137785 (51) [back to overview]Stinging/Burning
NCT02137785 (51) [back to overview]Stinging/Burning
NCT02137785 (51) [back to overview]Stinging/Burning
NCT02137785 (51) [back to overview]Stinging/Burning
NCT02137785 (51) [back to overview]Stinging/Burning
NCT02137785 (51) [back to overview]Stinging/Burning
NCT02137785 (51) [back to overview]Stinging/Burning
NCT02137785 (51) [back to overview]Stinging/Burning
NCT02137785 (51) [back to overview]Subject Satisfaction Score
NCT02144077 (8) [back to overview]Lesion Recurrence Rate (Cumulative)
NCT02144077 (8) [back to overview]Lesion Complete Response Assessed 12 Weeks After the Last PDT
NCT02144077 (8) [back to overview]Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT
NCT02144077 (8) [back to overview]Patient Complete Response 12 Weeks After PDT-2
NCT02144077 (8) [back to overview]Patient Recurrence Rate (Overall, Cumulative)
NCT02144077 (8) [back to overview]Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline
NCT02144077 (8) [back to overview]Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)
NCT02144077 (8) [back to overview]Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)
NCT02149342 (4) [back to overview]Pain Assesment (Visual Analog Scale)
NCT02149342 (4) [back to overview]Adverse Reactions
NCT02149342 (4) [back to overview]Clinical Lesion Clearance
NCT02149342 (4) [back to overview]Histological Lesion Clearance
NCT02157623 (3) [back to overview]Patient Satisfaction Survey
NCT02157623 (3) [back to overview]Tumor Clearance Rate Following Red or Blue Light PDT
NCT02157623 (3) [back to overview]Pain During Illumination
NCT02239679 (8) [back to overview]Proportion of Subjects With 0 AKs
NCT02239679 (8) [back to overview]Proportion of Subjects With 0 AKs
NCT02239679 (8) [back to overview]Proportion of Subjects With 0 AKs
NCT02239679 (8) [back to overview]Duration of Response
NCT02239679 (8) [back to overview]Recurrence Rate
NCT02239679 (8) [back to overview]Total Number of AKs in Treatment Area
NCT02239679 (8) [back to overview]Proportion of Subjects With 0 AKs
NCT02239679 (8) [back to overview]Proportion of Subjects With 0 AKs
NCT02281136 (29) [back to overview]Stinging/Burning
NCT02281136 (29) [back to overview]Stinging/Burning
NCT02281136 (29) [back to overview]Stinging/Burning
NCT02281136 (29) [back to overview]Erythema
NCT02281136 (29) [back to overview]Edema
NCT02281136 (29) [back to overview]Edema
NCT02281136 (29) [back to overview]Edema
NCT02281136 (29) [back to overview]Edema
NCT02281136 (29) [back to overview]Erythema
NCT02281136 (29) [back to overview]Erythema
NCT02281136 (29) [back to overview]Stinging/Burning
NCT02281136 (29) [back to overview]Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA
NCT02281136 (29) [back to overview]AUCt
NCT02281136 (29) [back to overview]The Terminal Exponential Half-life (T1/2,z)
NCT02281136 (29) [back to overview]Time at Which Cmax is Attained (Tmax) for ALA
NCT02281136 (29) [back to overview]Erythema
NCT02281136 (29) [back to overview]Hyperpigmentation
NCT02281136 (29) [back to overview]Hyperpigmentation
NCT02281136 (29) [back to overview]Hyperpigmentation
NCT02281136 (29) [back to overview]Hypopigmentation
NCT02281136 (29) [back to overview]Hypopigmentation
NCT02281136 (29) [back to overview]Hypopigmentation
NCT02281136 (29) [back to overview]OOZING/VESICULATION/CRUSTING
NCT02281136 (29) [back to overview]OOZING/VESICULATION/CRUSTING
NCT02281136 (29) [back to overview]OOZING/VESICULATION/CRUSTING
NCT02281136 (29) [back to overview]Scaling and Dryness
NCT02281136 (29) [back to overview]Scaling and Dryness
NCT02281136 (29) [back to overview]Scaling and Dryness
NCT02281136 (29) [back to overview]Stinging/Burning
NCT02409732 (5) [back to overview]Average Change in Participant Reported Pain
NCT02409732 (5) [back to overview]Average Change in Local Skin Reactions to Blue Light Treatment
NCT02409732 (5) [back to overview]Number of Participants With a Change in Clearance From Baseline
NCT02409732 (5) [back to overview]Number of Participants With Adverse Events
NCT02409732 (5) [back to overview]The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation
NCT02560584 (3) [back to overview]Proportion of Patients With Adverse Events Considered Causally Related to Cysview and/or Blue Light in the Surveillance Examination Compared With the OR Examination
NCT02560584 (3) [back to overview]Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy
NCT02560584 (3) [back to overview]Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy
NCT02594644 (2) [back to overview]Visual Analog Pain Scale
NCT02594644 (2) [back to overview]Difference in the Percentage of Complete Clearance of the Actinic Keratoses
NCT02628236 (9) [back to overview]AUCt/AUCBL for PpIX
NCT02628236 (9) [back to overview]Time at Which Cmax is Attained (Tmax) for ALA
NCT02628236 (9) [back to overview]Time at Which Cmax is Attained (Tmax) for PpIX
NCT02628236 (9) [back to overview]Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX
NCT02628236 (9) [back to overview]Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA
NCT02628236 (9) [back to overview]AUCt for PpIX
NCT02628236 (9) [back to overview]AUCt
NCT02628236 (9) [back to overview]AUCBL for PpIX
NCT02628236 (9) [back to overview]The Terminal Exponential Half-life (T1/2,z) for ALA
NCT02632110 (6) [back to overview]Complete Clearance Rate
NCT02632110 (6) [back to overview]Complete Clearance Rate
NCT02632110 (6) [back to overview]Percent Change
NCT02632110 (6) [back to overview]Percent Change
NCT02632110 (6) [back to overview]Baseline AKCR
NCT02632110 (6) [back to overview]Baseline AKCR
NCT02799069 (35) [back to overview]Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects
NCT02799069 (35) [back to overview]Local Discomfort During First Photodynamic Therapy (PDT-1)
NCT02799069 (35) [back to overview]Adverse Reactions
NCT02799069 (35) [back to overview]Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only
NCT02799069 (35) [back to overview]Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects
NCT02799069 (35) [back to overview]Local Discomfort - Pain During First Photodynamic Therapy (PDT-1)
NCT02799069 (35) [back to overview]Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only
NCT02799069 (35) [back to overview]Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Complete Lesion Response Rate 12 Weeks After Second PDT
NCT02799069 (35) [back to overview]Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT
NCT02799069 (35) [back to overview]Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP
NCT02799069 (35) [back to overview]Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT)
NCT02799069 (35) [back to overview]Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline
NCT02799069 (35) [back to overview]Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects
NCT02799069 (35) [back to overview]Local Skin Reactions During First Photodynamic Therapy (PDT-1)
NCT02799082 (15) [back to overview]Related Adverse Events /AEs)
NCT02799082 (15) [back to overview]Overall Cosmetic Outcome 12 Weeks After the Last PDT
NCT02799082 (15) [back to overview]Local Skin Reactions
NCT02799082 (15) [back to overview]Discomfort During and After PDT
NCT02799082 (15) [back to overview]Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)
NCT02799082 (15) [back to overview]Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)
NCT02799082 (15) [back to overview]Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)
NCT02799082 (15) [back to overview]Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)
NCT02799082 (15) [back to overview]Subjects With Partial Clearance 12 Weeks After the Last PDT
NCT02799082 (15) [back to overview]Subjects With Complete Clearance 12 Weeks After the First PDT
NCT02799082 (15) [back to overview]Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT
NCT02799082 (15) [back to overview]Change in Total Lesion Size 12 Weeks After the Last PDT
NCT02799082 (15) [back to overview]Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)
NCT02799082 (15) [back to overview]Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)
NCT02799082 (15) [back to overview]Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT
NCT03322293 (5) [back to overview]Percent Change in AK Lesion Count
NCT03322293 (5) [back to overview]Peak Pain Score at Day 8 Post-treatment
NCT03322293 (5) [back to overview]Change in Treatment Symptoms
NCT03322293 (5) [back to overview]Reduction of AK Counts
NCT03322293 (5) [back to overview]Change in Local Skin Reaction From Pre-treatment to 12 Weeks Post-treatment
NCT03511326 (2) [back to overview]Overall Subject Satisfaction at Week 12 Post-treatment
NCT03511326 (2) [back to overview]Overall Subject Satisfaction the Day of Treatment After Daylight Session
NCT03638622 (1) [back to overview]Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT)
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
NCT04319159 (20) [back to overview]Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
NCT04319159 (20) [back to overview]Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
NCT04319159 (20) [back to overview]Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
NCT04319159 (20) [back to overview]Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
NCT04319159 (20) [back to overview]Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
NCT04319159 (20) [back to overview]"Assessment of Pain Intensity at the Application Site in Response to PDT With BF-200 ALA Under Maximal Use Conditions Using an 11-point Numeric Rating Scale (NRS-11), Where a Score of 0 Means no Pain and a Score of 10 Means Worst Imaginable Pain."
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.
NCT04319159 (20) [back to overview]Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.

Recurrence Rate in Complete Clearance Group

Recurrence rate in complete clearance(CC) group was analyzed. (NCT00473343)
Timeframe: 12, 24, 36, 48 and 60 months after last Metvix PDT cycle, up to 5 years

InterventionParticipants (Count of Participants)
12 months24 months36 months48 months60 months
Metvix® PDT816202123

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Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle

Complete response was defined as no clinically visible BCC lesions in the treatment area. (NCT00473343)
Timeframe: 3 months after last Metvix PDT cycle, up to 6 months

Interventionlesions (Number)
Metvix® PDT141

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Percentage of Participants With Histologically Confirmed Patient Complete Response (CR) 3 Months After Last Metvix PDT Cycle

Patient Complete Response (CR) was defined as 100 percentage of the lesions within the participant having negative findings for nodular basal cell carcinoma (BCC) in the histological examination. (NCT00473343)
Timeframe: 3 months after last Metvix PDT cycle, up to 6 months

Interventionpercentage of participants (Number)
Metvix® PDT80

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Overall Cosmetic Outcome Assessed by Investigator 24, 36, 48, and 60 Months After the Last Metvix PDT Cycle

"Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:~excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration." (NCT00473343)
Timeframe: 24, 36, and 60 Months After the Last Metvix PDT Cycle, up to 5 years

InterventionParticipants (Count of Participants)
Excellent: At 24 monthGood: At 24 monthFair: At 24 monthPoor: At 24 monthExcellent: At 36 monthGood: At 36 monthFair: At 36 monthExcellent: At 60 monthGood: At 60 monthFair: At 60 month
Metvix® PDT341571311363571

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Overall Cosmetic Outcome Assessed by Investigator 3 Months After the Last Metvix PDT Cycle

"Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The investigator graded the cosmetic outcome as:~excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin~good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin~fair: slight to moderate occurrence of scarring, atrophy or induration~poor: extensive occurrence of scarring, atrophy or induration." (NCT00473343)
Timeframe: 3 months after the last metvix PDT cycle, up to 6 months

InterventionParticipants (Count of Participants)
Investigator: ExcellentInvestigator: GoodInvestigator: FairInvestigator: Not applicable
Metvix® PDT3716281

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Overall Cosmetic Outcome Assessed by Participants 3 Months After the Last Metvix PDT Cycle

"Cosmetic outcome was assessed by both investigator and participants in participants with 100% of lesions in complete response. Overall cosmetic outcome was assessed with regard to occurrence of the following signs or symptoms; scarring, atrophy, induration, redness or change in pigmentation. The participants graded the cosmetic outcome as:~excellent: no scarring, atrophy or induration, and no or slight occurrence of redness or change in pigmentation compared lo adjacent skin good: no scarring, atrophy or induration but moderate redness or change in pigmentation compared to adjacent skin fair: slight to moderate occurrence of scarring, atrophy or induration poor: extensive occurrence of scarring, atrophy or induration." (NCT00473343)
Timeframe: 3 months after the last metvix PDT cycle, up to 6 months

InterventionParticipants (Count of Participants)
Participants: ExcellentParticipants: GoodParticipants: FairParticipants: Not applicable
Metvix® PDT403920

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The Objective Response Rate is the Number of Participants With Significant Response (SR), Partial Response (PR) or No Response (NR).

The response rate was quantified by examination by an experienced head and neck surgeon and classified as follows: significant response (SR) was one where the lesion had greater than 75% resolution, partial response (PR) was one in which the lesion was reduced in size by at least 25%, and no response (NR) was one where the lesion was reduced by less than 25% in size. (NCT00571974)
Timeframe: Day 90

Interventionparticipants (Number)
Participants with Significant Response (SR)Participants with Partial Response (PR)Participants with no Response (NR)
Phase II791

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Maximum Tolerated Dose

The traditional 3+3 dose escalation design was employed. Three cohorts were enrolled at 3 subjects per cohort, and treated with escalating radiant exposures of 6, 7, or 8 J/cm2. In each cohort, the number of dose-limiting toxicities (DLTs) were observed. Dose escalation rules were the same as those provided by Storer 1989. (NCT00571974)
Timeframe: Day 2

InterventionJ/cm2 (Number)
Phase I8

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Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm (NCT00594425)
Timeframe: immediately after illumination-fourth treatment treatment

Interventioncm (Median)
40 mg/g MAL PDT1.10
80 mg/g MAL PDT2.50
Vehicle PDT0.0

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Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

(NCT00594425)
Timeframe: 12 weeks after last treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT4.4
80 mg/g MAL PDT5.3
Vehicle PDT6.7

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Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment

(NCT00594425)
Timeframe: 2 weeks after first treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT2.0
80 mg/g MAL PDT10.8
Vehicle PDT5.9

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Proportion of Patients With Mild and Moderate Erythema After Third Treatment

(NCT00594425)
Timeframe: immediately after third treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT67.4
80 mg/g MAL PDT71.1
Vehicle PDT16.7

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Proportion of Patients With Mild and Moderate Erythema After Second Treatment

(NCT00594425)
Timeframe: immediately after second treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT67.4
80 mg/g MAL PDT65.8
Vehicle PDT18.0

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Proportion of Patients With Mild and Moderate Erythema After Fourth Treatment

(NCT00594425)
Timeframe: immediately after fourth treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT45.9
80 mg/g MAL PDT63.1
Vehicle PDT15.2

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Proportion of Patients With Mild and Moderate Erythema After First Treatment

(NCT00594425)
Timeframe: immediately after first treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT75.1
80 mg/g MAL PDT61.7
Vehicle PDT17.6

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Proportion of Patients With Mild and Moderate Erythema After First Treatment

(NCT00594425)
Timeframe: 2 days after first treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT44.9
80 mg/g MAL PDT44.7
Vehicle PDT17.6

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Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline

(NCT00594425)
Timeframe: 6 weeks after last treatment

InterventionPercentage change (Median)
40 mg/g MAL PDT-38.5
80 mg/g MAL PDT-48.0
Vehicle PDT-38.0

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Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

(NCT00594425)
Timeframe: 6 weeks after last treatment

InterventionPercentage change (Median)
40 mg/g MAL PDT-52.0
80 mg/g MAL PDT-69.5
Vehicle PDT-52.0

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Median Percentage Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

(NCT00594425)
Timeframe: 3 weeks after last treatment

InterventionPercentage change (Median)
40 mg/g MAL PDT-44.5
80 mg/g MAL PDT-56.0
Vehicle PDT-40.5

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Proportion of Patients With Mild and Moderate Hyperpigmentation After First Treatment

(NCT00594425)
Timeframe: 2 days after treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT6.3
80 mg/g MAL PDT4.3
Vehicle PDT5.9

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Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm (NCT00594425)
Timeframe: immediately after third treatment

Interventioncm (Median)
40 mg/g MAL PDT1.5
80 mg/g MAL PDT2.0
Vehicle PDT0.0

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Proportion of Patients With Severe Erythema After Second Treatment

(NCT00594425)
Timeframe: immediately after second treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT0.0
80 mg/g MAL PDT0.0
Vehicle PDT0.0

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Proportion of Patients With Severe Erythema After Fourth Treatment

(NCT00594425)
Timeframe: immediately after fourth treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT0.0
80 mg/g MAL PDT0.0
Vehicle PDT0.0

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Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain.

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm (NCT00594425)
Timeframe: immediately after illumination-first treatment

Interventioncm (Median)
40 mg/g MAL PDT2.05
80 mg/g MAL PDT2.25
Vehicle PDT0.00

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Facial Pain Using Visual Analouge Scale From 0 to 10, Were 0 Indicates no Pain and 10 Indicates Worst Pain

Measure was assessed on a Visual Analogue Scale from 0 to 10 cm (NCT00594425)
Timeframe: immediately after second treatment

Interventioncm (Mean)
40 mg/g MAL PDT2.0
80 mg/g MAL PDT3.0
Vehicle PDT0.0

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Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline

(NCT00594425)
Timeframe: 12 weeks

Interventionlesions (Least Squares Mean)
40 mg/g MAL PDT-10.95
80 mg/g MAL PDT-11.8
Vehicle PDT-10.62

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Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts

(NCT00594425)
Timeframe: 12 weeks after last treatment

Interventionlesions (Least Squares Mean)
40 mg/g MAL PDT-10.72
80 mg/g MAL PDT-9.27
Vehicle PDT-8.08

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Proportion of Patients With Severe Erythema After First Treatment

(NCT00594425)
Timeframe: immediately after first treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT0.0
80 mg/g MAL PDT2.1
Vehicle PDT0.0

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Proportion of Patients With Severe Erythema 7 Days After First Treatment

(NCT00594425)
Timeframe: 7 days after first treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT2.0
80 mg/g MAL PDT0.0
Vehicle PDT0.0

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Proportion of Patients With Severe Erythema 2 Days After First Treatment

(NCT00594425)
Timeframe: 2 days after first treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT2.0
80 mg/g MAL PDT0.0
Vehicle PDT0.0

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Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

(NCT00594425)
Timeframe: 6 weeks after last treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT2.3
80 mg/g MAL PDT2.7
Vehicle PDT0.0

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Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

(NCT00594425)
Timeframe: 2 weeks after last treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT4.4
80 mg/g MAL PDT0.0
Vehicle PDT2.2

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Proportion of Patients With Mild and Moderate Hypopigmentation After Last Treatment

(NCT00594425)
Timeframe: 12 weeks after last treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT2.2
80 mg/g MAL PDT0.0
Vehicle PDT0.0

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Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment

(NCT00594425)
Timeframe: 2 weeks after first treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT2.0
80 mg/g MAL PDT0.0
Vehicle PDT0.0

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Proportion of Patients With Mild and Moderate Hypopigmentation After First Treatment

(NCT00594425)
Timeframe: 2 days after first treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT2.1
80 mg/g MAL PDT0.0
Vehicle PDT0.0

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Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

(NCT00594425)
Timeframe: 6 weeks after last treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT6.8
80 mg/g MAL PDT8.1
Vehicle PDT9.3

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Proportion of Patients With Mild and Moderate Hyperpigmentation After Last Treatment

(NCT00594425)
Timeframe: 2 weeks after last treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT8.6
80 mg/g MAL PDT21.1
Vehicle PDT4.4

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Proportion of Patients With Severe Erythema After Third Treatment

(NCT00594425)
Timeframe: immediately after third treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT0.0
80 mg/g MAL PDT0.0
Vehicle PDT0.0

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Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment

(NCT00594425)
Timeframe: 12 weeks after last treatment

InterventionPercentage of participants (Number)
40 mg/g MAL PDT16
80 mg/g MAL PDT14.58
Vehicle PDT11.54
40 mg/g MAL PDT17.5
80 mg/g MAL PDT21.2
Vehicle PDT16.7

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Proportion of Success, Defined as Improvement of at Least 2 Grades From Baseline According to the IGA Scale Based on Facial Assessment

(NCT00594425)
Timeframe: 6 weeks after last treatment

InterventionPrecentage of participants (Number)
40 mg/g MAL PDT10.5
80 mg/g MAL PDT18.8
Vehicle PDT12.2

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Percent Reduction in Total Lesion Counts From Baseline

(NCT00594425)
Timeframe: 6 weeks after last treatment

InterventionPercentage change (Median)
40 mg/g MAL PDT-40
80 mg/g MAL PDT-54
Vehicle PDT-37

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The Proportion of Patients Rated as Clear or Almost Clear at 12 Weeks After Last Treatment

(NCT00594425)
Timeframe: 12 weeks after last treatment

Interventionpercentage of participants (Number)
40 mg/g MAL PDT10.0
80 mg/g MAL PDT18.2
Vehicle PDT11.9

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Proportion of Patients With Moderate to Severe Hypopigmentation and Hyperpigmentation Assessed After Treatment

(NCT00673933)
Timeframe: 4 weeks after last treatment, 6 weeks after baseline

Interventionparticipants (Number)
Visonac Cream With PDT0
Vehicle Cream With PDT0

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Erythema Score (Mild and Moderate)Immediately After Second Treatment

Patients with mild or moderate erythema after second treatment. (NCT00673933)
Timeframe: Immediately after second treatment, 2 weeks after baseline

Interventionpercentage of participants (Number)
Visonac Cream With PDT11.1
Vehicle Cream With PDT0

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Erythema Score (Mild and Moderate)Immediately After First PDT

Patients with mild or moderate erythema after first treatment at baseline. (NCT00673933)
Timeframe: Immediately after treatment at baseline

Interventionpercentage of participants (Number)
Visonac Cream With PDT10.5
Vehicle Cream With PDT0.0

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Change in Noninflammatory Lesion Counts From Baseline

(NCT00673933)
Timeframe: 4 weeks after last treatment, 6 weeks after baseline

Interventionlesion count (Mean)
Visonac Cream With PDT-2.95
Vehicle Cream With PDT-2.50

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Change in Inflammatory Lesion Counts From Baseline

(NCT00673933)
Timeframe: 4 weeks after last treatment, 6 weeks after baseline

Interventionlesion count (Mean)
Visonac Cream With PDT-3.70
Vehicle Cream With PDT-3.90

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Erythema Score (Mild and Moderate)1 Day After First Treatment

Patients with mild or moderate erythema 1 day after first treatment. (NCT00673933)
Timeframe: 1 day after 1st treatment and baseline

Interventionpercentage of participants (Number)
Visonac Cream With PDT0
Vehicle Cream With PDT0

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Hypopigmentation at Visit 3 (Week 3)

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 3 (Week 3)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)
ALA 1000 Seconds6121
ALA 500 Seconds6200
Vehicle 1000 Seconds6110
Vehicle 500 Seconds6510

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Hypopigmentation at Visit 10 (6 Weeks After Final PDT)

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 10 (6 weeks after final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)
ALA 1000 Seconds6021
ALA 500 Seconds6200
Vehicle 1000 Seconds5700
Vehicle 500 Seconds6400

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Hypopigmentation 48 Hours Post PDT #1

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: 48 hours post PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)
ALA 1000 Seconds6710
ALA 500 Seconds6410
Vehicle 1000 Seconds6501
Vehicle 500 Seconds6420

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Hyperpigmentation at Visit 9 (3 Weeks After Final PDT)

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 9 (3 weeks after final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - mod)Grade 4 (marked)
ALA 1000 Seconds4512500
ALA 500 Seconds4910200
Vehicle 1000 Seconds4311300
Vehicle 500 Seconds517500

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Hyperpigmentation at Visit 7 (Week 9)

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 7 (Week 9)

,,,
Interventionparticipant (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - mod)Grade 4 (marked)
ALA 1000 Seconds499410
ALA 500 Seconds4911200
Vehicle 1000 Seconds4511100
Vehicle 500 Seconds5210300

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Hyperpigmentation at Visit 5 (Week 6)

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 5 (Week 6)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - mod)Grade 4 (marked)
ALA 1000 Seconds4413320
ALA 500 Seconds519300
Vehicle 1000 Seconds4612200
Vehicle 500 Seconds498420

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Hyperpigmentation at Visit 3 (Week 3)

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 3 (Week 3)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - mod)Grade 4 (marked)
ALA 1000 Seconds4910410
ALA 500 Seconds5010200
Vehicle 1000 Seconds4810400
Vehicle 500 Seconds528420

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Hyperpigmentation at Visit 10 (6 Weeks After Final PDT)

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 10 (6 weeks after final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - mod)Grade 4 (marked)
ALA 1000 Seconds4812120
ALA 500 Seconds509210
Vehicle 1000 Seconds467400
Vehicle 500 Seconds5010310

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Hyperpigmentation 48 Hours After PDT #1

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: 48 hours after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - mod)Grade 4 (marked)
ALA 1000 Seconds4914410
ALA 500 Seconds4914101
Vehicle 1000 Seconds4910700
Vehicle 500 Seconds537330

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Erythema at Visit 7 (Week 9 - Prior to Study Drug Application)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 7 (Week 9 - prior to study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds3723300
ALA 500 Seconds3422600
Vehicle 1000 Seconds3122400
Vehicle 500 Seconds3625400

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Erythema at Visit 7 (Week 9 - Pre Light Treatment)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 7 (Week 9 - pre light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds28161110
ALA 500 Seconds2624820
Vehicle 1000 Seconds28161110
Vehicle 500 Seconds3321710

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Erythema at Visit 7 (Week 9 - Post Light Treatment)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 7 (Week 9 - post light treatment)

,,,
Interventionparticipant (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds20132210
ALA 500 Seconds14182170
Vehicle 1000 Seconds20191520
Vehicle 500 Seconds18231920

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Erythema at Visit 5 (Weeks 6 - Pre-light Treatment)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 5 (Weeks 6 - pre-light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds2722900
ALA 500 Seconds20281210
Vehicle 1000 Seconds2229900
Vehicle 500 Seconds29211110

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Erythema at Visit 5 (Week 6 - Prior to Study Drug Application)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 5 (Week 6 - prior to study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds3620600
ALA 500 Seconds3521700
Vehicle 1000 Seconds3122700
Vehicle 500 Seconds3423600

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Erythema at Visit 5 (Week 6 - Post Light Treatment)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 5 (Week 6 - post light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds18161941
ALA 500 Seconds13182460
Vehicle 1000 Seconds15281520
Vehicle 500 Seconds19241720

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Erythema at Visit 3 (Week 3 - Pre-light)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 3 (Week 3 - pre-light)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds27241100
ALA 500 Seconds30181210
Vehicle 1000 Seconds2727710
Vehicle 500 Seconds32201210

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Erythema at Visit 3 (Week 3 - Pre Study Drug Application)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 3 (Week 3 - pre study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds3620800
ALA 500 Seconds35161100
Vehicle 1000 Seconds3423500
Vehicle 500 Seconds3423900

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Erythema at Visit 3 (Week 3 - Post Light Treatment)

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Visit 3 (Week 3 - post light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds13281740
ALA 500 Seconds16201861
Vehicle 1000 Seconds18301310
Vehicle 500 Seconds21231920

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Erythema at Baseline (Pre-light)

"After solution application, prior to light treatment~Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema" (NCT00706433)
Timeframe: Baseline (pre-light)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds29241320
ALA 500 Seconds31201310
Vehicle 1000 Seconds35191210
Vehicle 500 Seconds29251200

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Erythema at Baseline - Post Light Treatment

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: Baseline - post light treatment

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds16232630
ALA 500 Seconds18241670
Vehicle 1000 Seconds22192240
Vehicle 500 Seconds21271530

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Erythema 6 Weeks After Final PDT

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: 6 Weeks after Final PDT

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds3921300
ALA 500 Seconds3320900
Vehicle 1000 Seconds3022500
Vehicle 500 Seconds4320100

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Erythema 48 Hours After PDT #1

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: 48 hours after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds192414101
ALA 500 Seconds16212332
Vehicle 1000 Seconds3425610
Vehicle 500 Seconds2930700

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Erythema 3 Weeks After Final PDT

Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT00706433)
Timeframe: 3 Weeks after Final PDT

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds3621500
ALA 500 Seconds3518800
Vehicle 1000 Seconds3221400
Vehicle 500 Seconds4216500

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Edema at Visit 7 (Week 9 - Prior to Light Treatment)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 7 (Week 9 - prior to light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds5330
ALA 500 Seconds5910
Vehicle 1000 Seconds5600
Vehicle 500 Seconds6200

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Edema at Visit 7 (Week 9 - Post Light Treatment)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 7 (Week 9 - post light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds5330
ALA 500 Seconds5910
Vehicle 1000 Seconds5510
Vehicle 500 Seconds6110

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Edema at Visit 7 (Week 9 - Before Study Drug Application)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 7 (Week 9 - before study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6030
ALA 500 Seconds6200
Vehicle 1000 Seconds5610
Vehicle 500 Seconds6500

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Edema at Visit 5 (Week 6 - Pre Light Treatment)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 5 (Week 6 - pre light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds5620
ALA 500 Seconds6100
Vehicle 1000 Seconds5910
Vehicle 500 Seconds6110

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Edema at Visit 5 (Week 6 - Post Light Treatment)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 5 (Week 6 - post light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)
ALA 1000 Seconds5530
ALA 500 Seconds6100
Vehicle 1000 Seconds5730
Vehicle 500 Seconds6200

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Edema at Visit 5 (Week 6 - Before Study Drug Application)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 5 (Week 6 - before study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6020
ALA 500 Seconds6300
Vehicle 1000 Seconds5910
Vehicle 500 Seconds6210

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Edema at Visit 3 (Week 3 - Post Light Treatment)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 3 (Week 3 - post light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6020
ALA 500 Seconds5920
Vehicle 1000 Seconds6110
Vehicle 500 Seconds6410

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Edema at Visit 3 (Week 3 - Before Study Drug Application)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 3 (Week 3 - before study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6220
ALA 500 Seconds6110
Vehicle 1000 Seconds6110
Vehicle 500 Seconds6600

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Edema at Visit 3 (Week 3 - Before Light Treatment)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Visit 3 (Week 3 - before light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6020
ALA 500 Seconds6010
Vehicle 1000 Seconds6110
Vehicle 500 Seconds6500

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Edema at Baseline - Pre Light Treatment

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Baseline - pre light treatment

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6530
ALA 500 Seconds6320
Vehicle 1000 Seconds6430
Vehicle 500 Seconds6510

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Edema at Baseline - Post Light Treatment

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: Baseline - Post Light Treatment

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6251
ALA 500 Seconds6320
Vehicle 1000 Seconds6430
Vehicle 500 Seconds6510

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Edema 6 Weeks After Final PDT

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: 6 weeks after final PDT

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6210
ALA 500 Seconds6200
Vehicle 1000 Seconds5700
Vehicle 500 Seconds6400

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Edema 48 Hours After PDT #1

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: 48 hours after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6440
ALA 500 Seconds5771
Vehicle 1000 Seconds6150
Vehicle 500 Seconds6420

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Edema 3 Weeks After Final PDT

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT00706433)
Timeframe: 3 weeks after final PDT

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA 1000 Seconds6200
ALA 500 Seconds6010
Vehicle 1000 Seconds5700
Vehicle 500 Seconds6300

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Percent Change in Inflammatory Lesion Counts Relative to Baseline

(NCT00706433)
Timeframe: Baseline and 6 weeks after final treatment

Interventionpercent change in lesion count (Median)
ALA 1000 Seconds-34.4
ALA 500 Seconds-29.0
Vehicle 1000 Seconds-48.4
Vehicle 500 Seconds-45.2

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Percent Change in Inflammatory Lesion Counts Relative to Baseline

(NCT00706433)
Timeframe: Baseline and 3 weeks after final treatment

Interventionpercent change in lesion count (Median)
ALA 1000 Seconds-37.5
ALA 500 Seconds-29.2
Vehicle 1000 Seconds-41.7
Vehicle 500 Seconds-37.0

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Change in Inflammatory Lesion Counts Relative to Baseline

change in lesion counts compared to baseline (NCT00706433)
Timeframe: Baseline and 6 weeks after final treatment

Interventionchange in lesion count (Median)
ALA 1000 Seconds-18.5
ALA 500 Seconds-13.0
Vehicle 1000 Seconds-21.0
Vehicle 500 Seconds-17.0

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Change in Inflammatory Lesion Counts Relative to Baseline

(NCT00706433)
Timeframe: Baseline and 3 weeks after final treatment

Interventionchange in lesion count (Median)
ALA 1000 Seconds-18.0
ALA 500 Seconds-14.0
Vehicle 1000 Seconds-19.0
Vehicle 500 Seconds-14.5

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Scaling and Dryness at Visit 9 (3 Weeks After Final PDT)

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT00706433)
Timeframe: Visit 9 (3 Weeks after Final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds527300
ALA 500 Seconds4910200
Vehicle 1000 Seconds4410300
Vehicle 500 Seconds5111100

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Oozing/Vesiculation/Crusting at Visit 7 (Week 9)

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT00706433)
Timeframe: Visit 7 (Week 9)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)
ALA 1000 Seconds61200
ALA 500 Seconds58400
Vehicle 1000 Seconds53310
Vehicle 500 Seconds63200

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Oozing/Vesiculation/Crusting at Visit 5 (Week 6)

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT00706433)
Timeframe: Visit 5 (Week 6)

,,,
Interventionparticipant (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)
ALA 1000 Seconds59300
ALA 500 Seconds57600
Vehicle 1000 Seconds56310
Vehicle 500 Seconds61200

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Oozing/Vesiculation/Crusting at Visit 3 (Week 3)

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT00706433)
Timeframe: Visit 3 (Week 3)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)
ALA 1000 Seconds58510
ALA 500 Seconds59300
Vehicle 1000 Seconds59210
Vehicle 500 Seconds65010

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Oozing/Vesiculation/Crusting at Visit 10 (6 Weeks After Final PDT)

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT00706433)
Timeframe: Visit 10 (6 Weeks after Final PDT)

,,,
Interventionparticpants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)
ALA 1000 Seconds60300
ALA 500 Seconds60200
Vehicle 1000 Seconds55200
Vehicle 500 Seconds63100

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Oozing/Vesiculation/Crusting 48 Hours After PDT #1

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT00706433)
Timeframe: 48 hours after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)
ALA 1000 Seconds62321
ALA 500 Seconds62021
Vehicle 1000 Seconds63210
Vehicle 500 Seconds62400

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Investigator Global Assessment of Acne Severity Successes

Scale consists of Grade 0 (clear skin) to Grade 4 (severe: up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions) This assessment uses a dichotomized success/failure assessment - with success defined as a 2 point or more improvement on the IGA scale since baseline. (NCT00706433)
Timeframe: Baseline and 3 weeks after final treatment

,,,
Interventionparticipants (Number)
SuccessFailure
ALA 1000 Seconds1355
ALA 500 Seconds1154
Vehicle 1000 Seconds1552
Vehicle 500 Seconds1155

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Investigator Global Assessment of Acne Severity Successes

"Assessment uses a dichotomized success/failure assessment with success defined as a 2 point or more improvement since baseline.~0 Clear skin with no inflam or non-inflam lesions~Almost clear; rare non-inflam lesions with no more than a few small inflam lesions~Mild; > Grade 1; some non-inflam lesions with some inflam lesions (papules/pustules only; no nodules)~Moderate; > Grade 2; up to many non-inflam lesions and a moderate number of inflam lesions but no more than one small nodule~Severe; > Grade 3; up to many non-inflam and inflam lesions, but no more than a few nodules" (NCT00706433)
Timeframe: Baesline and 6 weeks after final treatment

,,,
Interventionparticipants (Number)
SuccessFailure
ALA 1000 Seconds1553
ALA 500 Seconds1154
Vehicle 1000 Seconds1651
Vehicle 500 Seconds1650

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Hypopigmentation at Visit 9 (3 Weeks After Final PDT)

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 9 (3 weeks after final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)
ALA 1000 Seconds5840
ALA 500 Seconds6100
Vehicle 1000 Seconds5700
Vehicle 500 Seconds6300

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Hypopigmentation at Visit 7 (Week 9)

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 7 (Week 9)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)
ALA 1000 Seconds6120
ALA 500 Seconds6200
Vehicle 1000 Seconds5700
Vehicle 500 Seconds6500

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Hypopigmentation at Visit 5 (Week 6)

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT00706433)
Timeframe: Visit 5 (Week 6)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)
ALA 1000 Seconds5930
ALA 500 Seconds6300
Vehicle 1000 Seconds6000
Vehicle 500 Seconds6300

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Oozing/Vesiculation/Crusting at Visit 9 (3 Weeks After Final PDT)

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT00706433)
Timeframe: Visit 9 (3 Weeks after Final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)
ALA 1000 Seconds59300
ALA 500 Seconds59200
Vehicle 1000 Seconds51600
Vehicle 500 Seconds60300

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Scaling and Dryness 48 Hours After PDT #1

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT00706433)
Timeframe: 48 hours after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds3820640
ALA 500 Seconds3520631
Vehicle 1000 Seconds4714311
Vehicle 500 Seconds4914210

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Scaling and Dryness at Visit 10 (6 Weeks After Final PDT)

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT00706433)
Timeframe: Visit 10 (6 Weeks after Final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds4615200
ALA 500 Seconds4515110
Vehicle 1000 Seconds4310400
Vehicle 500 Seconds567100

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Scaling and Dryness at Visit 3 (Week 3)

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT00706433)
Timeframe: Visit 3 (Week 3)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds5211100
ALA 500 Seconds4811210
Vehicle 1000 Seconds4414400
Vehicle 500 Seconds558300

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Scaling and Dryness at Visit 5 (Week 6)

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT00706433)
Timeframe: Visit 5 (Week 6)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds526400
ALA 500 Seconds5013000
Vehicle 1000 Seconds4014420
Vehicle 500 Seconds519210

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Scaling and Dryness at Visit 7 (Week 9)

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT00706433)
Timeframe: Visit 7 (Week 9)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds4417200
ALA 500 Seconds5010200
Vehicle 1000 Seconds4111320
Vehicle 500 Seconds565400

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Stinging/Burning 48 Hours Post PDT #1

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: 48 hours post PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds61610
ALA 500 Seconds52832
Vehicle 1000 Seconds64200
Vehicle 500 Seconds63300

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Stinging/Burning at Baseline - Before Light Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Baseline - before light treatment

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds56750
ALA 500 Seconds521120
Vehicle 1000 Seconds64300
Vehicle 500 Seconds62400

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Stinging/Burning at Baseline - During Light

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Baseline - during light

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds432140
ALA 500 Seconds332660
Vehicle 1000 Seconds59620
Vehicle 500 Seconds58710

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Stinging/Burning at Baseline - Post Light Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Baseline - post light treatment

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 2 (minimal)Grade 3 (moderate)Grade 4 (severe)
ALA 1000 Seconds531410
ALA 500 Seconds471710
Vehicle 1000 Seconds63400
Vehicle 500 Seconds62400

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Stinging/Burning at Visit 10 (6 Weeks After Final PDT)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 10 (6 Weeks after Final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds63000
ALA 500 Seconds61100
Vehicle 1000 Seconds57000
Vehicle 500 Seconds63100

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Stinging/Burning at Visit 3 (Week 3 - Before Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 3 (Week 3 - before light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds53630
ALA 500 Seconds491020
Vehicle 1000 Seconds62000
Vehicle 500 Seconds61400

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Stinging/Burning at Visit 3 (Week 3 - Before Study Drug Application)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 3 (Week 3 - before study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds61210
ALA 500 Seconds61100
Vehicle 1000 Seconds60200
Vehicle 500 Seconds64200

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Stinging/Burning at Visit 3 (Week 3 - During Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 3 (Week 3 - during light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds46970
ALA 500 Seconds331981
Vehicle 1000 Seconds59300
Vehicle 500 Seconds58700

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Stinging/Burning at Visit 3 (Week 3 - Post Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 3 (Week 3 - post light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds53630
ALA 500 Seconds49930
Vehicle 1000 Seconds60200
Vehicle 500 Seconds59600

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Stinging/Burning at Visit 5 (Week 6 - Before Study Drug Application)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 5 (Week 6 - before study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds61100
ALA 500 Seconds62100
Vehicle 1000 Seconds60000
Vehicle 500 Seconds62010

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Stinging/Burning at Visit 5 (Week 6 - During Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 5 (Week 6 - during light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds411070
ALA 500 Seconds3416110
Vehicle 1000 Seconds57210
Vehicle 500 Seconds59210

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Stinging/Burning at Visit 5 (Week 6 - Post Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 5 (Week 6 - post light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds471010
ALA 500 Seconds49840
Vehicle 1000 Seconds59010
Vehicle 500 Seconds60110

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Stinging/Burning at Visit 5 (Week 6 - Prior to Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 5 (Week 6 - prior to light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds50710
ALA 500 Seconds491020
Vehicle 1000 Seconds56310
Vehicle 500 Seconds59210

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Stinging/Burning at Visit 7 (Week 9 - Before Study Drug Application)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 7 (Week 9 - before study drug application)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds63000
ALA 500 Seconds62000
Vehicle 1000 Seconds57000
Vehicle 500 Seconds63200

[back to top]

Stinging/Burning at Visit 7 (Week 9 - During Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 7 (Week 9 - during light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds391430
ALA 500 Seconds2821101
Vehicle 1000 Seconds54200
Vehicle 500 Seconds59300

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Stinging/Burning at Visit 7 (Week 9 - Post Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 7 (Week 9 - post light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds49700
ALA 500 Seconds401460
Vehicle 1000 Seconds54200
Vehicle 500 Seconds61100

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Stinging/Burning at Visit 7 (Week 9 - Prior to Light Treatment)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 7 (Week 9 - prior to light treatment)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds48800
ALA 500 Seconds51630
Vehicle 1000 Seconds55100
Vehicle 500 Seconds62000

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Stinging/Burning at Visit 9 (3 Weeks After Final PDT)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT00706433)
Timeframe: Visit 9 (3 Weeks after Final PDT)

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (moderate)Grade 3 (severe)
ALA 1000 Seconds61100
ALA 500 Seconds61000
Vehicle 1000 Seconds57000
Vehicle 500 Seconds62001

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Subject Satisfaction Score

"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)" (NCT00706433)
Timeframe: 6 weeks after final treatment

,,,
Interventionparticipants (Number)
ExcellentGoodFairPoor
ALA 1000 Seconds2318176
ALA 500 Seconds1128175
Vehicle 1000 Seconds2320114
Vehicle 500 Seconds2623125

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Eradication of HPV

High risk HPV (NCT00708942)
Timeframe: 6 months

Interventionpercentage of no. of patients analyzed (Number)
Arm 1: HAL Suppository, Laser Illumination60.0
Arm 2: Placebo Suppository, Laser Illumination28.6
Arm 3: No Intervention100
Arm 4: HAL Ointment, LED Diode Illumination50.0
Arm 5: Placebo Ointment, no Illumination33.3

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Complete Response Rate

"Based on histology, cytology and HPV status. Complete response is defined as normal pathology, normal cytology and negative HPV." (NCT00708942)
Timeframe: 6 month

Interventionpercentage of no. of patients analyzed (Number)
Arm 1: HAL Suppository, Laser Illumination57.1
Arm 2: Placebo Suppository, Laser Illumination40.0
Arm 3: No Intervention0.0
Arm 4: HAL Ointment, LED Diode Illumination90.0
Arm 5: Placebo Ointment, no Illumination33.3

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Incidence of Patients With Adverse Events

(NCT00708942)
Timeframe: 3 months

Interventionpercentage of no of patients analyzed (Number)
Arm 1: HAL Suppository, Laser Illumination44.7
Arm 2: Placebo Suppository, Laser Illumination25.0
Arm 3: No Intervention18.2
Arm 4: HAL Ointment, LED Diode Illumination70.0
Arm 5: Placebo Ointment, no Illumination66.7

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Determine the Sensitivity, Specificity, and Positive Predictive Value of 5-ALA Mediated Fluorescence for Malignant Glioma Tissue in the Brain.

"The neurosurgeon will take two small biopsies per patient from areas identified as obvious tumor and areas in the wall of the resection cavity that were judged to be normal, non-eloquent brain. A neuropathologist will review all biopsy specimens, including those taken from the solid tumor. Pathologic confirmation of tumor type will be made by the study reference neuropathologist.~We assessed 5-ALA's resulting fluorescence for distinguishing tumor within the brain, where~True Positive: Fluorescence showing Tumor and Biopsy result Tumor False Positive: Fluorescence showing Tumor and Biopsy result No Tumor True Negative: No Fluorescence and Biopsy result No Tumor False Negative: No Fluorescence and Biopsy result Tumor~These values represent the characteristics of 5-ALA aka its ability to distinguish tumor from non-tumor. From these parameters we determined sensitivity, specificity and the positive and negative predictive values." (NCT01128218)
Timeframe: Baseline

InterventionPercentage (Number)
SensitivitySpecificityPositive Predictive ValueNegative Predictive Value
Phase 2 Dose Level 1 (40mg/kg)63.6410010042.86

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Establish a Safe Dose for Oral 5-ALA Administration

Dose escalation from 10mg/kg to 50mg/kg to determine optimal 5-ALA dose (NCT01128218)
Timeframe: 6 months

InterventionDose Limiting Toxicity (Number)
Phase 1 Dose Level 1 (10mg/kg)0
Phase 1 Dose Level 2 (20mg/kg)0
Phase 1 Dose Level 3 (30mg/kg)0
Phase 1 Dose Level 4 (40mg/kg)0
Phase 1 Dose Level 5 (50mg/kg)0

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Assess 5-ALA's Resulting Fluorescence for Distinguishing Tumor Within the Brain

"Under blue light, the neurosurgeon will take two small biopsies per patient from areas identified as obvious tumor (fluorescent) and areas in the wall of the resection cavity that were judged to be normal (but possibly edematous), non-eloquent brain (non-fluorescent). A neuropathologist will review all biopsy specimens, including those taken from the solid tumor. Pathologic confirmation of tumor type will be made by the study reference neuropathologist.~We assessed 5-ALA's resulting fluorescence for distinguishing tumor within the brain, where~True Positive: Fluorescence showing Tumor and Biopsy result Tumor False Positive: Fluorescence showing Tumor and Biopsy result No Tumor True Negative: No Fluorescence and Biopsy result No Tumor False Negative: No Fluorescence and Biopsy result Tumor~These values represent the characteristics of 5-ALA aka its ability to distinguish tumor from non-tumor." (NCT01128218)
Timeframe: Baseline

InterventionBiopsies (Number)
True PositivesTrue NegativesFalse PositivesFalse Negatives
Phase 2 Dose Level 1 (40mg/kg)14608

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Actinic Keratosis Count

The percent change in actinic keratosis count as compared to the baseline lesion count (NCT01203878)
Timeframe: Week 18 (4 weeks after randomization visit)

Interventionpercent reduction in baseline count (Mean)
Imiquimod Followed by Photodynamic Therapy81
Imiquimod Followed by Observation83

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Cosmetic Appearance

"Change (improvement) in investigator scores of cosmetic appearance of the treatment area (entire face) by objective and subjective assessments:~INVESTIGATOR COSMETIC ASSESSMENT 0 - Facial skin is smooth to the touch, without significant lines or unevenness in pigmentation~1 - Facial skin shows 1 area (cheeks, forehead, or the perioral area) of significant 3 - Facial skin shows 3 areas with significant roughness, dyspigmentation, or fine lines 2 - Facial skin shows 2 areas of significant roughness, dyspigmentation, or fine lines 4 - All are severe in severity" (NCT01203878)
Timeframe: Week 18 (4 weeks after randomization visit)

Interventionunits on a scale (Mean)
Imiquimod Followed by Photodynamic Therapy1.67
Imiquimod Followed by Observation1.25

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Complete Clearance

The proportion of randomized patients with complete clearance of actinic keratoses in the treatment area (entire face). (NCT01203878)
Timeframe: Week 18 (4 weeks after randomization visit)

Interventionparticipants (Number)
Imiquimod Followed by Photodynamic Therapy5
Imiquimod Followed by Observation2

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Safety, Tolerability, and Feasibility of Combination Intra-operative 5-ALA and Gliadel Wafers Prior to Adjuvant Radiotherapy Plus Temozolomide

"Procedure compliance: Proportion of 5-ALA resected patients who received Carmustine wafer implants (e.g to take into account rates of patients who did not receive Carmustine wafer implants due to 1) ventricular breach, 2) inaccurate peri-operative diagnosis, 3) intra-operative surgical decision)~Post-operative complication rate: Proportion of patients with a new post-operative deficit or surgical complication (wound infection, CSF leakage, intracranial hypertension)~No. of patients with chemoRT delay (i.e number who do not begin chemoRT 6 weeks after surgery) due to surgical complications*~No. of patients failing to start chemoRT due to surgical complications rather than tumour progression~No. of patients failing to complete chemoRT without interruption (RT with concomitant chemotherapy, and RT with concomitant plus adjuvant chemotherapy)~Proportion of patients with a lower WHO performance status after surgery with Carmustine wafers (at first post-operative clinic visit)" (NCT01310868)
Timeframe: Date of surgery to end of temozolomide and radiotherapy treatment (up to 34 weeks)

InterventionParticipants (Count of Participants)
5-ALA resected patients receiving carmustine waferNo. patients with post-op complicationsNo. Patients with chemoRT delayNo. pts failing to complete uninterrupted chemoRTno. pts w decr perform status after 5ala/carmustinno. pts not starting chemoRT due to surgical comp
5-ALA and Gliadel Wafers629645272

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Time to Clinical Progression

(NCT01310868)
Timeframe: from the date of surgery to the date of the first MRI scan fitting the criteria for progression, or the date the clinical detrioration or death was first reported

Interventionmonths (Median)
5-ALA and Gliadel Wafers9.5

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Survival at 24 Months

(NCT01310868)
Timeframe: from the date of surgery to 24 months

Interventionmonths (Median)
5-ALA and Gliadel Wafers15

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Hyperpigmentation at Baseline

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01458587)
Timeframe: Baseline

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)
ALA-OCC519101
ALA+OCC52091
VEH-OCC12383
VEH+OCC12383

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Erythema Post-Light Treatment

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01458587)
Timeframe: 5 Minutes after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC0419102
ALA+OCC007217
VEH-OCC4151330
VEH+OCC4111730

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Erythema at Visit 5

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01458587)
Timeframe: 12 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC7121400
ALA+OCC971610
VEH-OCC1214900
VEH+OCC11141000

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Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. (NCT01458587)
Timeframe: Baseline and Week 8

Interventionarms >75% cleared (Number)
ALA+OCC18
ALA-OCC5
VEH+OCC1
VEH-OCC2

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Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. (NCT01458587)
Timeframe: Baseline and Week 12

Interventionarms >75% cleared (Number)
ALA+OCC21
ALA-OCC15
VEH+OCC3
VEH-OCC2

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Lesion Clearance Rate

Clearance rate for all lesions (NCT01458587)
Timeframe: Week 12

Interventionpercentage of lesions cleared (Median)
ALA+OCC88.7
ALA-OCC70.0
VEH+OCC16.7
VEH-OCC5.6

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Lesion Clearance Rate

(NCT01458587)
Timeframe: Week 8

Interventionpercentage of lesions cleared (Median)
ALA+OCC75.0
ALA-OCC47.4
VEH+OCC3.3
VEH-OCC6.3

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Complete Clearance Rate

proportion of subjects with a count of zero lesions in the treatment area (NCT01458587)
Timeframe: Week 8

Interventionarms 100% cleared (Number)
ALA+OCC8
ALA-OCC4
VEH+OCC0
VEH-OCC0

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Complete Clearance Rate

proportion of subjects with a count of zero lesions in the treatment area (NCT01458587)
Timeframe: Week 12

Interventionarms 100% cleared (Number)
ALA+OCC12
ALA-OCC7
VEH+OCC0
VEH-OCC1

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Erythema at Visit 3

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01458587)
Timeframe: 2 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC4141520
ALA+OCC0814121
VEH-OCC10141010
VEH+OCC1015910

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Erythema at Baseline

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01458587)
Timeframe: Baseline

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC1016900
ALA+OCC1016810
VEH-OCC12121010
VEH+OCC1213910

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Edema Post-Light Treatment

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01458587)
Timeframe: 5 Minutes after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA-OCC3320
ALA+OCC2852
VEH-OCC3410
VEH+OCC3410

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Edema at Visit 5

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01458587)
Timeframe: 12 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA-OCC3300
ALA+OCC3300
VEH-OCC3500
VEH+OCC3500

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Edema at Visit 4

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01458587)
Timeframe: 8 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA-OCC3500
ALA+OCC3500
VEH-OCC3400
VEH+OCC3400

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Erythema at Visit 4

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01458587)
Timeframe: 8 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC620900
ALA+OCC717920
VEH-OCC1115710
VEH+OCC1016710

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Stinging/Burning at Visit 4

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT01458587)
Timeframe: 8 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-OCC35000
ALA+OCC35000
VEH-OCC34000
VEH+OCC34000

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Scaling and Dryness at Visit 3

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01458587)
Timeframe: 2 Weeks Post PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC5171030
ALA+OCC355211
VEH-OCC1119320
VEH+OCC1020320

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Edema at Baseline

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01458587)
Timeframe: Baseline

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA-OCC3500
ALA+OCC3500
VEH-OCC3500
VEH+OCC3500

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Edema at Visit 3

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01458587)
Timeframe: 2 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)
ALA-OCC3410
ALA+OCC2753
VEH-OCC3500
VEH+OCC3500

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Stinging/Burning at Visit 5

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT01458587)
Timeframe: 12 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-OCC33000
ALA+OCC33000
VEH-OCC35000
VEH+OCC35000

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Hyperpigmentation at Visit 3

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01458587)
Timeframe: 2 weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)
ALA-OCC420101
ALA+OCC41992
VEH-OCC121103
VEH+OCC121103

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Stinging/Burning During Light Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT01458587)
Timeframe: During PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-OCC020123
ALA+OCC05219
VEH-OCC29600
VEH+OCC29600

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Hyperpigmentation at Visit 5

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01458587)
Timeframe: 12 weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)
ALA-OCC22380
ALA+OCC22560
VEH-OCC020114
VEH+OCC020114

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Hypopigmentation at Baseline

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation (NCT01458587)
Timeframe: Baseline

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)
ALA-OCC92150
ALA+OCC92150
VEH-OCC82421
VEH+OCC82421

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Hypopigmentation at Visit 3

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation (NCT01458587)
Timeframe: 2 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)
ALA-OCC102050
ALA+OCC102040
VEH-OCC72611
VEH+OCC72611

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Hypopigmentation at Visit 4

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation (NCT01458587)
Timeframe: 8 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)
ALA-OCC102140
ALA+OCC131831
VEH-OCC92311
VEH+OCC92311

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Stinging/Burning Post Light Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT01458587)
Timeframe: 5 minutes after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-OCC222101
ALA+OCC07217
VEH-OCC33200
VEH+OCC30500

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OOZING/VESICULATION/CRUSTING at Baseline

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01458587)
Timeframe: Baseline

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC350000
ALA+OCC350000
VEH-OCC350000
VEH+OCC350000

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OOZING/VESICULATION/CRUSTING at Visit 3

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01458587)
Timeframe: Week 2 after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)0
ALA-OCC340100
ALA+OCC331010
VEH-OCC341000
VEH+OCC341000

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OOZING/VESICULATION/CRUSTING at Visit 4

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01458587)
Timeframe: 8 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)0
ALA-OCC350000
ALA+OCC350000
VEH-OCC340000
VEH+OCC340000

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OOZING/VESICULATION/CRUSTING at Visit 5

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01458587)
Timeframe: 12 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)0
ALA-OCC321000
ALA+OCC330000
VEH-OCC350000
VEH+OCC350000

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Scaling and Dryness at Baseline

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01458587)
Timeframe: Baseline

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC1615220
ALA+OCC1615220
VEH-OCC1713410
VEH+OCC1713410

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Hypopigmentation at Visit 5

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation (NCT01458587)
Timeframe: 12 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)
ALA-OCC82410
ALA+OCC102210
VEH-OCC112211
VEH+OCC122111

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Scaling and Dryness at Visit 5

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01458587)
Timeframe: 12 Weeks Post PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC1713210
ALA+OCC1812210
VEH-OCC1217510
VEH+OCC1217510

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Stinging/Burning at Baseline

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT01458587)
Timeframe: Baseline

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-OCC35000
ALA+OCC35000
VEH-OCC35000
VEH+OCC35000

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Stinging/Burning at Visit 3

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT01458587)
Timeframe: 2 Weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-OCC35000
ALA+OCC31400
VEH-OCC35000
VEH+OCC35000

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Subject Satisfaction Score

"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)" (NCT01458587)
Timeframe: Week 12

,,,
Interventionparticipants (Number)
Very satisfiedModerately satisfiedSlightly satisfiedNot satisfied
ALA-OCC71486
ALA+OCC131633
VEH-OCC15920
VEH+OCC35720

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Hyperpigmentation at Visit 4

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01458587)
Timeframe: 8 weeks after PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)
ALA-OCC221111
ALA+OCC22481
VEH-OCC017134
VEH+OCC019114

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Scaling and Dryness at Visit 4

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01458587)
Timeframe: 8 Weeks Post PDT #1

,,,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-OCC1712510
ALA+OCC1614410
VEH-OCC1414330
VEH+OCC1414330

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Lesion Response

Percent of lesions treated at Baseline, in complete response at Week 12 (NCT01475071)
Timeframe: Week12

Interventionpercentage of lesions complete response (Mean)
Metvix and Daylight89.2
Metvix and Lamp92.8

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Pain Score

Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain) (NCT01475071)
Timeframe: Baseline (during procedure), assessed after procedure

Interventionunits on a scale (Mean)
Metvix and Daylight0.8
Metvix and Lamp5.7

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AK Clearance Rate

"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]" (NCT01475955)
Timeframe: Baseline, Week 24

Interventionpercent clearance (Median)
Broad Area ALA 1-hour + BLUE Light Treatment66.7
Broad Area ALA 2-hour + BLUE Light Treatment64.9
Broad Area ALA 3-hour + BLUE Light Treatment75.0
Spot ALA 2-hour + BLUE Light Treatment63.4
Vehicle + BLUE Light Treatment14.3

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AK Clearance Rate

"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]" (NCT01475955)
Timeframe: Baseline, Week 4

Interventionpercent clearance (Median)
Broad Area ALA 1-hour + BLUE Light Treatment40
Broad Area ALA 2-hour + BLUE Light Treatment58.4
Broad Area ALA 3-hour + BLUE Light Treatment54.5
Spot ALA 2-hour + BLUE Light Treatment56.3
Vehicle + BLUE Light Treatment0.0

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AK Clearance Rate

"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]" (NCT01475955)
Timeframe: Baseline, Week 8

Interventionpercent clearance (Median)
Broad Area ALA 1-hour + BLUE Light Treatment35.7
Broad Area ALA 2-hour + BLUE Light Treatment52.5
Broad Area ALA 3-hour + BLUE Light Treatment57.1
Spot ALA 2-hour + BLUE Light Treatment57.1
Vehicle + BLUE Light Treatment5.7

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Complete Clearance Rate

The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area (NCT01475955)
Timeframe: Week 12

Interventionparticipants (Number)
Broad Area ALA 1-hour + BLUE Light Treatment14
Broad Area ALA 2-hour + BLUE Light Treatment7
Broad Area ALA 3-hour + BLUE Light Treatment13
Spot ALA 2-hour + BLUE Light Treatment8
Vehicle + BLUE Light Treatment1

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Complete Clearance Rate

the proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area (NCT01475955)
Timeframe: Week 24

Interventionparticipants (Number)
Broad Area ALA 1-hour + BLUE Light Treatment11
Broad Area ALA 2-hour + BLUE Light Treatment3
Broad Area ALA 3-hour + BLUE Light Treatment12
Spot ALA 2-hour + BLUE Light Treatment2
Vehicle + BLUE Light Treatment1

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Complete Clearance Rate

The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area (NCT01475955)
Timeframe: Week 4

Interventionparticipants (Number)
Broad Area ALA 1-hour + BLUE Light Treatment5
Broad Area ALA 2-hour + BLUE Light Treatment8
Broad Area ALA 3-hour + BLUE Light Treatment5
Spot ALA 2-hour + BLUE Light Treatment4
Vehicle + BLUE Light Treatment0

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Complete Clearance Rate

The proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area (NCT01475955)
Timeframe: Week 8

Interventionparticipants (Number)
Broad Area ALA 1-hour + BLUE Light Treatment3
Broad Area ALA 2-hour + BLUE Light Treatment7
Broad Area ALA 3-hour + BLUE Light Treatment8
Spot ALA 2-hour + BLUE Light Treatment4
Vehicle + BLUE Light Treatment0

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Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. (NCT01475955)
Timeframe: Baseline Week 24

Interventionparticipants (Number)
Broad Area ALA 1-hour + BLUE Light Treatment18
Broad Area ALA 2-hour + BLUE Light Treatment19
Broad Area ALA 3-hour + BLUE Light Treatment24
Spot ALA 2-hour + BLUE Light Treatment17
Vehicle + BLUE Light Treatment3

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Stinging/Burning at Visit 2

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: 24-48 hours post PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment251840
Broad Area ALA 2-hour + BLUE Light Treatment232041
Broad Area ALA 3-hour + BLUE Light Treatment201773
Spot ALA 2-hour + BLUE Light Treatment351010
Vehicle + BLUE Light Treatment41410

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Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. (NCT01475955)
Timeframe: Baseline, Week 12

Interventionparticipants (Number)
Broad Area ALA 1-hour + BLUE Light Treatment23
Broad Area ALA 2-hour + BLUE Light Treatment24
Broad Area ALA 3-hour + BLUE Light Treatment25
Spot ALA 2-hour + BLUE Light Treatment20
Vehicle + BLUE Light Treatment5

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Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. (NCT01475955)
Timeframe: Baseline, Week 4

Interventionparticipants (Number)
Broad Area ALA 1-hour + BLUE Light Treatment12
Broad Area ALA 2-hour + BLUE Light Treatment16
Broad Area ALA 3-hour + BLUE Light Treatment14
Spot ALA 2-hour + BLUE Light Treatment12
Vehicle + BLUE Light Treatment2

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Partial Clearance Rate

proportion of subjects with 75% or more reduction in the AK count in the Treatment Area as compared to baseline. (NCT01475955)
Timeframe: Baseline, Week 8

Interventionparticipants (Number)
Broad Area ALA 1-hour + BLUE Light Treatment10
Broad Area ALA 2-hour + BLUE Light Treatment13
Broad Area ALA 3-hour + BLUE Light Treatment15
Spot ALA 2-hour + BLUE Light Treatment13
Vehicle + BLUE Light Treatment1

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Edema at Baseline

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: Baseline

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment00000
Broad Area ALA 2-hour + BLUE Light Treatment00000
Broad Area ALA 3-hour + BLUE Light Treatment10000
Spot ALA 2-hour + BLUE Light Treatment00000
Vehicle + BLUE Light Treatment00000

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Edema at Visit 2

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: 24-48 hours post PDT#1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment328520
Broad Area ALA 2-hour + BLUE Light Treatment3110331
Broad Area ALA 3-hour + BLUE Light Treatment2610641
Spot ALA 2-hour + BLUE Light Treatment2713420
Vehicle + BLUE Light Treatment442000

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Edema at Visit 4

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: Week 4

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment461000
Broad Area ALA 2-hour + BLUE Light Treatment471000
Broad Area ALA 3-hour + BLUE Light Treatment460000
Spot ALA 2-hour + BLUE Light Treatment460000
Vehicle + BLUE Light Treatment450000

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Edema at Visit 5 (Pre-drug)

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: Week 8 pre-drug

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment470000
Broad Area ALA 2-hour + BLUE Light Treatment480000
Broad Area ALA 3-hour + BLUE Light Treatment450000
Spot ALA 2-hour + BLUE Light Treatment460000
Vehicle + BLUE Light Treatment440000

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Edema at Week 12

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: Week 12

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment470000
Broad Area ALA 2-hour + BLUE Light Treatment480000
Broad Area ALA 3-hour + BLUE Light Treatment431000
Spot ALA 2-hour + BLUE Light Treatment460000
Vehicle + BLUE Light Treatment440000

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Edema Post PDT #2

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: 5 minutes post PDT #2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment326210
Broad Area ALA 2-hour + BLUE Light Treatment2012410
Broad Area ALA 3-hour + BLUE Light Treatment187330
Spot ALA 2-hour + BLUE Light Treatment2611400
Vehicle + BLUE Light Treatment431000

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Edema Post-Light Treatment

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: 5 minutes after PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment378200
Broad Area ALA 2-hour + BLUE Light Treatment2812710
Broad Area ALA 3-hour + BLUE Light Treatment2711360
Spot ALA 2-hour + BLUE Light Treatment3310300
Vehicle + BLUE Light Treatment442000

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Erythema at Baseline

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: Baseline

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - Moderate
Broad Area ALA 1-hour + BLUE Light Treatment1423100
Broad Area ALA 2-hour + BLUE Light Treatment1023150
Broad Area ALA 3-hour + BLUE Light Treatment152480
Spot ALA 2-hour + BLUE Light Treatment191980
Vehicle + BLUE Light Treatment1518112

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Erythema at Visit 2

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: 24-48 hours after PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment2810252
Broad Area ALA 2-hour + BLUE Light Treatment0314238
Broad Area ALA 3-hour + BLUE Light Treatment14121812
Spot ALA 2-hour + BLUE Light Treatment0119242
Vehicle + BLUE Light Treatment13171420

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Erythema at Visit 3

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: Week 2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment11221310
Broad Area ALA 2-hour + BLUE Light Treatment5231820
Broad Area ALA 3-hour + BLUE Light Treatment11191430
Spot ALA 2-hour + BLUE Light Treatment1426600
Vehicle + BLUE Light Treatment1521810

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Erythema at Visit 4

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: Week 4

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment1227800
Broad Area ALA 2-hour + BLUE Light Treatment13221300
Broad Area ALA 3-hour + BLUE Light Treatment1620910
Spot ALA 2-hour + BLUE Light Treatment1226710
Vehicle + BLUE Light Treatment14181210

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Erythema at Visit 5 (Post-light)

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: Week 8 5 minutes post light treatment

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment1819121
Broad Area ALA 2-hour + BLUE Light Treatment0510193
Broad Area ALA 3-hour + BLUE Light Treatment177160
Spot ALA 2-hour + BLUE Light Treatment0919130
Vehicle + BLUE Light Treatment428750

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Erythema at Visit 5 (Pre-drug)

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: Week 8 pre-drug

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment1325900
Broad Area ALA 2-hour + BLUE Light Treatment15171600
Broad Area ALA 3-hour + BLUE Light Treatment1722510
Spot ALA 2-hour + BLUE Light Treatment2119600
Vehicle + BLUE Light Treatment12201020

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Erythema at Visit 6

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: Week 12

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment1624700
Broad Area ALA 2-hour + BLUE Light Treatment15231000
Broad Area ALA 3-hour + BLUE Light Treatment1819700
Spot ALA 2-hour + BLUE Light Treatment2219410
Vehicle + BLUE Light Treatment1718810

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Erythema at Visit 7

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: Week 24

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment2019710
Broad Area ALA 2-hour + BLUE Light Treatment at Visit 1 and Vi16201200
Broad Area ALA 3-hour + BLUE Light Treatment1920500
Spot ALA 2-hour + BLUE Light Treatment2715400
Vehicle + BLUE Light Treatment2116720

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Erythema Post-Light Treatment

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT01475955)
Timeframe: 5 minutes after PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment2819162
Broad Area ALA 2-hour + BLUE Light Treatment0416262
Broad Area ALA 3-hour + BLUE Light Treatment0513227
Spot ALA 2-hour + BLUE Light Treatment0918181
Vehicle + BLUE Light Treatment4251430

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Hyperpigmentation at Baseline

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Baseline

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderate
Broad Area ALA 1-hour + BLUE Light Treatment1223120
Broad Area ALA 2-hour + BLUE Light Treatment824142
Broad Area ALA 3-hour + BLUE Light Treatment172361
Spot ALA 2-hour + BLUE Light Treatment142192
Vehicle + BLUE Light Treatment112771

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Hyperpigmentation at Visit 2

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: 24-48 Hours after PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderate
Broad Area ALA 1-hour + BLUE Light Treatment171992
Broad Area ALA 2-hour + BLUE Light Treatment1224111
Broad Area ALA 3-hour + BLUE Light Treatment182351
Spot ALA 2-hour + BLUE Light Treatment1519111
Vehicle + BLUE Light Treatment162541

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Hyperpigmentation at Visit 3

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderate
Broad Area ALA 1-hour + BLUE Light Treatment1618121
Broad Area ALA 2-hour + BLUE Light Treatment1027101
Broad Area ALA 3-hour + BLUE Light Treatment202151
Spot ALA 2-hour + BLUE Light Treatment162370
Vehicle + BLUE Light Treatment152442

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Hyperpigmentation at Visit 4

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 4

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderate
Broad Area ALA 1-hour + BLUE Light Treatment1621100
Broad Area ALA 2-hour + BLUE Light Treatment1125111
Broad Area ALA 3-hour + BLUE Light Treatment221563
Spot ALA 2-hour + BLUE Light Treatment162190
Vehicle + BLUE Light Treatment122571

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Hyperpigmentation at Visit 5

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 8

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderate
Broad Area ALA 1-hour + BLUE Light Treatment1619120
Broad Area ALA 2-hour + BLUE Light Treatment1126101
Broad Area ALA 3-hour + BLUE Light Treatment172071
Spot ALA 2-hour + BLUE Light Treatment142381
Vehicle + BLUE Light Treatment112562

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Hyperpigmentation at Visit 6

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 12

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderate
Broad Area ALA 1-hour + BLUE Light Treatment1718111
Broad Area ALA 2-hour + BLUE Light Treatment92982
Broad Area ALA 3-hour + BLUE Light Treatment181691
Spot ALA 2-hour + BLUE Light Treatment172081
Vehicle + BLUE Light Treatment112481

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Hyperpigmentation at Visit 7

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 24

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderateGrade 4 - Marked
Broad Area ALA 1-hour + BLUE Light Treatment1623701
Broad Area ALA 2-hour + BLUE Light Treatment9271020
Broad Area ALA 3-hour + BLUE Light Treatment2019410
Spot ALA 2-hour + BLUE Light Treatment1821610
Vehicle + BLUE Light Treatment1325710

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Hypopigmentation at Baseline

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Baseline

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/small
Broad Area ALA 1-hour + BLUE Light Treatment21215
Broad Area ALA 2-hour + BLUE Light Treatment20253
Broad Area ALA 3-hour + BLUE Light Treatment30161
Spot ALA 2-hour + BLUE Light Treatment22231
Vehicle + BLUE Light Treatment18244

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Hypopigmentation at Visit 2

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: 24-48 Hours after PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/small
Broad Area ALA 1-hour + BLUE Light Treatment25166
Broad Area ALA 2-hour + BLUE Light Treatment24204
Broad Area ALA 3-hour + BLUE Light Treatment31142
Spot ALA 2-hour + BLUE Light Treatment23221
Vehicle + BLUE Light Treatment23203

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Hypopigmentation at Visit 3

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/small
Broad Area ALA 1-hour + BLUE Light Treatment25175
Broad Area ALA 2-hour + BLUE Light Treatment23223
Broad Area ALA 3-hour + BLUE Light Treatment31142
Spot ALA 2-hour + BLUE Light Treatment21241
Vehicle + BLUE Light Treatment20214

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Hypopigmentation at Visit 4

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 4

,,,,
Interventionparticipants (Number)
Grade - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderate
Broad Area ALA 1-hour + BLUE Light Treatment251750
Broad Area ALA 2-hour + BLUE Light Treatment202110
Broad Area ALA 3-hour + BLUE Light Treatment291601
Spot ALA 2-hour + BLUE Light Treatment192610
Vehicle + BLUE Light Treatment192240

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Hypopigmentation at Visit 5

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 8

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/small
Broad Area ALA 1-hour + BLUE Light Treatment23213
Broad Area ALA 2-hour + BLUE Light Treatment19263
Broad Area ALA 3-hour + BLUE Light Treatment28170
Spot ALA 2-hour + BLUE Light Treatment17254
Vehicle + BLUE Light Treatment18233

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Hypopigmentation at Visit 6

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 12

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/smallGrade 3 - Moderate/moderate
Broad Area ALA 1-hour + BLUE Light Treatment232130
Broad Area ALA 2-hour + BLUE Light Treatment202620
Broad Area ALA 3-hour + BLUE Light Treatment261800
Spot ALA 2-hour + BLUE Light Treatment192061
Vehicle + BLUE Light Treatment152630

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Hypopigmentation at Visit 7

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT01475955)
Timeframe: Week 24

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - LightGrade 2 - Moderate/small
Broad Area ALA 1-hour + BLUE Light Treatment22223
Broad Area ALA 2-hour + BLUE Light Treatment18273
Broad Area ALA 3-hour + BLUE Light Treatment28151
Spot ALA 2-hour + BLUE Light Treatment20242
Vehicle + BLUE Light Treatment17254

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Oozing/Vesiculation/Crusting at Baseline

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01475955)
Timeframe: Baseline

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - Moderate
Broad Area ALA 1-hour + BLUE Light Treatment45110
Broad Area ALA 2-hour + BLUE Light Treatment47010
Broad Area ALA 3-hour + BLUE Light Treatment46100
Spot ALA 2-hour + BLUE Light Treatment43300
Vehicle + BLUE Light Treatment44110

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Oozing/Vesiculation/Crusting at Visit 2

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01475955)
Timeframe: 24-48 hours after PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment432200
Broad Area ALA 2-hour + BLUE Light Treatment394410
Broad Area ALA 3-hour + BLUE Light Treatment345440
Spot ALA 2-hour + BLUE Light Treatment349210
Vehicle + BLUE Light Treatment432100

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Oozing/Vesiculation/Crusting at Visit 3

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01475955)
Timeframe: Week 2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - Moderate
Broad Area ALA 1-hour + BLUE Light Treatment45110
Broad Area ALA 2-hour + BLUE Light Treatment42510
Broad Area ALA 3-hour + BLUE Light Treatment45110
Spot ALA 2-hour + BLUE Light Treatment45010
Vehicle + BLUE Light Treatment45000

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Oozing/Vesiculation/Crusting at Visit 4

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01475955)
Timeframe: Week 4

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - Moderate
Broad Area ALA 1-hour + BLUE Light Treatment46100
Broad Area ALA 2-hour + BLUE Light Treatment45300
Broad Area ALA 3-hour + BLUE Light Treatment46000
Spot ALA 2-hour + BLUE Light Treatment46000
Vehicle + BLUE Light Treatment45000

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Oozing/Vesiculation/Crusting at Visit 5

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01475955)
Timeframe: Week 8

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - Moderate
Broad Area ALA 1-hour + BLUE Light Treatment47000
Broad Area ALA 2-hour + BLUE Light Treatment47100
Broad Area ALA 3-hour + BLUE Light Treatment45000
Spot ALA 2-hour + BLUE Light Treatment44200
Vehicle + BLUE Light Treatment42101

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Oozing/Vesiculation/Crusting at Visit 6

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01475955)
Timeframe: Week 12

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - Moderate
Broad Area ALA 1-hour + BLUE Light Treatment46100
Broad Area ALA 2-hour + BLUE Light Treatment48000
Broad Area ALA 3-hour + BLUE Light Treatment44000
Spot ALA 2-hour + BLUE Light Treatment46000
Vehicle + BLUE Light Treatment44000

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Oozing/Vesiculation/Crusting at Visit 7

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT01475955)
Timeframe: Week 24

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - Moderate
Broad Area ALA 1-hour + BLUE Light Treatment47000
Broad Area ALA 2-hour + BLUE Light Treatment48000
Broad Area ALA 3-hour + BLUE Light Treatment44000
Spot ALA 2-hour + BLUE Light Treatment45100
Vehicle + BLUE Light Treatment46000

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Scaling and Dryness at Baseline

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01475955)
Timeframe: Baseline

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment2516600
Broad Area ALA 2-hour + BLUE Light Treatment2419500
Broad Area ALA 3-hour + BLUE Light Treatment2617400
Spot ALA 2-hour + BLUE Light Treatment2915200
Vehicle + BLUE Light Treatment1621630

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Scaling and Dryness at Visit 2

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01475955)
Timeframe: 24-48 hours after PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment19131050
Broad Area ALA 2-hour + BLUE Light Treatment2016840
Broad Area ALA 3-hour + BLUE Light Treatment2215451
Spot ALA 2-hour + BLUE Light Treatment1723600
Vehicle + BLUE Light Treatment1822600

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Scaling and Dryness at Visit 3

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01475955)
Timeframe: Week 2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment2217710
Broad Area ALA 2-hour + BLUE Light Treatment2115831
Broad Area ALA 3-hour + BLUE Light Treatment2016830
Spot ALA 2-hour + BLUE Light Treatment2716300
Vehicle + BLUE Light Treatment1920600

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Scaling and Dryness at Visit 4

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01475955)
Timeframe: Week 4

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment2419310
Broad Area ALA 2-hour + BLUE Light Treatment2418600
Broad Area ALA 3-hour + BLUE Light Treatment2717110
Spot ALA 2-hour + BLUE Light Treatment2814400
Vehicle + BLUE Light Treatment1822410

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Scaling and Dryness at Visit 5

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01475955)
Timeframe: Week 8

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment2321300
Broad Area ALA 2-hour + BLUE Light Treatment3016200
Broad Area ALA 3-hour + BLUE Light Treatment3111300
Spot ALA 2-hour + BLUE Light Treatment3113200
Vehicle + BLUE Light Treatment1718900

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Scaling and Dryness at Visit 6

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01475955)
Timeframe: Week 12

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment3213200
Broad Area ALA 2-hour + BLUE Light Treatment3412200
Broad Area ALA 3-hour + BLUE Light Treatment3013010
Spot ALA 2-hour + BLUE Light Treatment3311200
Vehicle + BLUE Light Treatment2317400

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Scaling and Dryness at Visit 7

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT01475955)
Timeframe: Week 24

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment3113300
Broad Area ALA 2-hour + BLUE Light Treatment2622000
Broad Area ALA 3-hour + BLUE Light Treatment3211100
Spot ALA 2-hour + BLUE Light Treatment378100
Vehicle + BLUE Light Treatment2812510

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Stinging/Burning at Baseline

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: Baseline

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment47000
Broad Area ALA 2-hour + BLUE Light Treatment48000
Broad Area ALA 3-hour + BLUE Light Treatment47000
Spot ALA 2-hour + BLUE Light Treatment46000
Vehicle + BLUE Light Treatment44200

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Edema at Week 24

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: Week 24

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment470000
Broad Area ALA 2-hour + BLUE Light Treatment480000
Broad Area ALA 3-hour + BLUE Light Treatment431000
Spot ALA 2-hour + BLUE Light Treatment451000
Vehicle + BLUE Light Treatment451000

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Stinging/Burning at Visit 3

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: Week 2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment46100
Broad Area ALA 2-hour + BLUE Light Treatment45300
Broad Area ALA 3-hour + BLUE Light Treatment44210
Spot ALA 2-hour + BLUE Light Treatment46000
Vehicle + BLUE Light Treatment45000

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Stinging/Burning at Visit 4

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: Week 4

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment45200
Broad Area ALA 2-hour + BLUE Light Treatment47100
Broad Area ALA 3-hour + BLUE Light Treatment46000
Spot ALA 2-hour + BLUE Light Treatment46000
Vehicle + BLUE Light Treatment44010

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Stinging/Burning at Visit 5 (Pre-drug)

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: Week 8 prior to drug

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment47000
Broad Area ALA 2-hour + BLUE Light Treatment48000
Broad Area ALA 3-hour + BLUE Light Treatment45000
Spot ALA 2-hour + BLUE Light Treatment45100
Vehicle + BLUE Light Treatment42200

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Stinging/Burning at Visit 5 During PDT#2

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: during PDT #2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment420152
Broad Area ALA 2-hour + BLUE Light Treatment111205
Broad Area ALA 3-hour + BLUE Light Treatment07168
Spot ALA 2-hour + BLUE Light Treatment423131
Vehicle + BLUE Light Treatment281600

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Stinging/Burning at Visit 5 Post PDT#2

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: 5 minutes post PDT #2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment72680
Broad Area ALA 2-hour + BLUE Light Treatment218152
Broad Area ALA 3-hour + BLUE Light Treatment214114
Spot ALA 2-hour + BLUE Light Treatment102290
Vehicle + BLUE Light Treatment35900

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Stinging/Burning at Visit 6

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: Week 12

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment47000
Broad Area ALA 2-hour + BLUE Light Treatment48000
Broad Area ALA 3-hour + BLUE Light Treatment44000
Spot ALA 2-hour + BLUE Light Treatment44200
Vehicle + BLUE Light Treatment43100

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Stinging/Burning at Visit 7

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: Week 24

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment47000
Broad Area ALA 2-hour + BLUE Light Treatment48000
Broad Area ALA 3-hour + BLUE Light Treatment44000
Spot ALA 2-hour + BLUE Light Treatment45100
Vehicle + BLUE Light Treatment46000

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Stinging/Burning During Light Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: During PDT #1 (most intense sensation)

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment215237
Broad Area ALA 2-hour + BLUE Light Treatment19299
Broad Area ALA 3-hour + BLUE Light Treatment0102215
Spot ALA 2-hour + BLUE Light Treatment316198
Vehicle + BLUE Light Treatment351160

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Stinging/Burning Post Light-Treatment

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable The most intense stinging/burning sensation during the 16 minute 40 second light treatment will be recorded. (NCT01475955)
Timeframe: 5 minutes post PDT #1

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MInimalGrade 2 - ModerateGrade 3 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment82982
Broad Area ALA 2-hour + BLUE Light Treatment517251
Broad Area ALA 3-hour + BLUE Light Treatment119198
Spot ALA 2-hour + BLUE Light Treatment825130
Vehicle + BLUE Light Treatment40600

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Subject Satisfaction Score

"0 = no improvement or worsening (not satisfied at all)~= slight improvement (slightly satisfied)~= moderate improvement (moderately satisfied)~= excellent improvement (very satisfied)" (NCT01475955)
Timeframe: Week 24

,,,,
Interventionparticipants (Number)
3 = excellent improvement (very satisfied)2 = moderate improvement (moderately satisfied)1 = slight improvement (slightly satisfied)0 = no improvement or worsening (not satisfied at
Broad Area ALA 1-hour + BLUE Light Treatment201467
Broad Area ALA 2-hour + BLUE Light Treatment211692
Broad Area ALA 3-hour + BLUE Light Treatment201914
Spot ALA 2-hour + BLUE Light Treatment201727
Vehicle + BLUE Light Treatment79624

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Edema at Visit 3

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT01475955)
Timeframe: Week 2

,,,,
Interventionparticipants (Number)
Grade 0 - NoneGrade 1 - MinimalGrade 2 - MildGrade 3 - ModerateGrade 4 - Severe
Broad Area ALA 1-hour + BLUE Light Treatment461000
Broad Area ALA 2-hour + BLUE Light Treatment442200
Broad Area ALA 3-hour + BLUE Light Treatment421400
Spot ALA 2-hour + BLUE Light Treatment442000
Vehicle + BLUE Light Treatment441000

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AK Clearance Rate

"AK Clearance Rate (AKCR) for a subject is defined as:~100% x [1 - (Number of AK lesions in the Treatment Area at follow-up visit/Number of AK lesions in the Treatment Area at Baseline)]" (NCT01475955)
Timeframe: Baseline, Week 12

Interventionpercent clearance (Median)
Broad Area ALA 1-hour + BLUE Light Treatment71.4
Broad Area ALA 2-hour + BLUE Light Treatment73.6
Broad Area ALA 3-hour + BLUE Light Treatment78.6
Spot ALA 2-hour + BLUE Light Treatment68.3
Vehicle + BLUE Light Treatment7.1

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Change in Volume of Residual Enhancing Tumor, as Determined by Intraoperative Volume MRI at a Single Time Point Without and With Gadolinium, Following Maximal Resection With Use of Aminolevulinic Acid

Volume of enhancing tumor (initial and residual) will be determined by use of a softwarebased volumetric analysis method. Intra- and post-op definitions of residual tumor volume need to be adjusted for the presence of T1 hyperintensity due to signal from blood and blood products (as determined on pre-gadolinium volume study). (NCT01575275)
Timeframe: Day 1

Interventioncc (Median)
Diagnostic (Aminolevulinic Acid)-0.342

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Overall Survival, by Periodic Follow up Review of the Patient Charts and by Correlation With the Social Security Death Index

(NCT01575275)
Timeframe: From the date of surgery with aminolevulinic acid to the date of death, assessed up to 4 years

Interventionmonths (Median)
Diagnostic (Aminolevulinic Acid)16

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Part 1: Optimal Occlusion Time

An optimal occlusion time may be apparent from the results of the three time points. If no optimal occlusion time is seen, any occlusion time from 3-24 hours may be chosen for part 2. This secondary outcome measure is not critical to continuing the study, but may be useful in guiding treatment protocols (NCT01682811)
Timeframe: 24 hours

Interventionhours (Number)
Part 1 Levulan Injection Control LesionsNA
Part 1 Levulan Injection Treated Lesions 3 HoursNA
Part 1 Levulan Injection Treated Lesions 24 HoursNA
Part 1 Levulan Paint Control LesionsNA
Part 1 Levulan Paint Treated Lesions 3 HoursNA
Part 1 Levulan Paint Treated Lesions 24 HoursNA

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Part 1: Photosensitizer Uptake and Conversion to Protoporphyrin IX

The average fluorescence value for PpIX positive tumor areas in excised, sectioned tumors, as determined by fluorescence microscopy. PpIX signals were detected with excitation at 405 nm and emission with a 600 nm long pass filter. PpIX positive areas were determined to be those exhibiting fluorescence above background levels. (NCT01682811)
Timeframe: 24 hours

InterventionDensitometry units/micrometer squared (Mean)
Part 1 Levulan Painted Twice Treated Lesions With Microneedling304

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Part 2: Efficacy - Lesion Area Growth Rate

Average lesion growth rates observed in ALA-treated lesions compared to vehicle-treated lesions within the same subjects. (NCT01682811)
Timeframe: 12 weeks

Interventionmillimeter squared/day post-treatment (Mean)
Part 2 Dose Level 1 50 J/cm^2 Control0.212
Part 2 Dose Level 1 50 J/cm^2 Treated0.081

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Part 2: Maximum Tolerated Dose (MTD) of 633 nm Red Light

MTD was determined by testing increasing doses up to 200 J/cm^2 on dose escalation cohorts 1 to 3 with 3 to 6 participants each. MTD reflects the highest dose of red light that did not cause a Dose-Limiting Toxicity (DLT) in > 33% of participants. DLT was defined as pain during irradiation requiring cessation of the light treatment, or any serious cutaneous adverse events. (NCT01682811)
Timeframe: 48 hours

Interventionjoules/cm squared (Number)
All Participants100

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TUNEL Assay.

Average number of apoptotic cells per visual field among all TUNEL-evaluated lesion samples. (NCT01682811)
Timeframe: 48 hours

Interventionapoptotic cells/visual field (Mean)
Part 2 Dose Level 1 50 J/cm^2 Control42.5
Part 2 Dose Level 1 50 J/cm^2 Treated1.1

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Actinic Keratoses Reduction Percent

(NCT01812837)
Timeframe: one month after treatment

,,
Interventionpercentage (Mean)
Microneedle PretreatmentControl
20 Minute Microneedle Pretreatment Incubation71.468.3
40 Minute Microneedle Pretreatment Incubation80.280.1
60 Minute Microneedle Pretreatment Incubation72.573.6

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Histological Lesion Clearance

Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal) (NCT01893203)
Timeframe: 0 (baseline) and 3 months

Interventionpercentage of complete clearance (Number)
BF-200 ALAMAL
BF200 ALA vs MAL61.538.5

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Pain

"Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m.~(treatment day). Of these values, the mean maximal pain is assessed." (NCT01893203)
Timeframe: 12 hours

Interventionunits on a scale (Mean)
BF-200 ALA treatment sidesMAL treatment sides
BF200 ALA vs MAL1.71.9

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Clinical Lesion Clearance

Clinical lesion clearance is observed by a blinded observer (NCT01893203)
Timeframe: 3 months

Interventionpercentage of complete clearance (Number)
BF-200 ALA treated lesionsMAL treated lesions
BF200 ALA vs MAL84.574.2

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Adverse Reactions

Adverse reactions are evaluated by blinded observer at one week after treatment. A dermatologist will assess which side of the face or scalp presents a stronger reaction. (NCT01893203)
Timeframe: 1 week

Interventionparticipants (Number)
BF-200 ALA treated areasMAL treated areasNo difference between the sides
BF200 ALA vs MAL751

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Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 1 to 3

"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.~The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).~The outcome was calculated using a 5-point scale ranging from very good (0) to impaired (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)." (NCT01966120)
Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

,
Interventionpercentage of participants (Number)
Very goodGoodSatisfactoryUnsatisfactoryImpaired
BF-200 ALA39.627.122.96.34.2
Placebo to BF-200 ALA19.215.423.126.915.4

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Patient Recurrence Rate in Follow-up (Cumulative)

Cumulative numbers of patients with complete response who showed recurrences 12 months after last treatment (PDT-1 or PDT-2, if re-treated). A patient with complete response was regarded as recurrent if at least one baseline AK lesion recurred during the follow-up (FU). Complete response was achieved if all treated lesions of the patient were cleared 12 weeks after the last treatment (PDT-1 or PDT-2, if re-treated). Lesions that showed recurrence at 6-months (FU1) were also defined as recurrent at 12-months follow-up (FU2). (NCT01966120)
Timeframe: 12 months after last treatment (PDT-1 or PDT-2, if re-treated)

,
InterventionParticipants (Count of Participants)
Patients cleared 12 weeks after last PDT with any recurrent baseline AK lesion at 12-months FUPatients cleared 12 weeks after last PDT still completely cleared at 12 months FU
BF-200 ALA1831
Placebo to BF-200 ALA16

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Patients' Satisfaction in Follow-up (12 Months)

Patients' satisfaction of the overall cosmetic outcome was assessed at 12-months follow-up visit using a 5-point scale, where 0=very good, 1=good, 2=satisfactory, 3=unsatisfactory, and 4=impaired. The lowest rating is the best outcome, the highest rating is the worst outcome. (NCT01966120)
Timeframe: 12 months after last treatment (PDT-1 or PDT-2, if re-treated)

,
Interventionpercentage of patients (Number)
Very good or goodVery goodGoodSatisfactoryUnsatisfactoryImpaired
BF-200 ALA77.835.242.618.53.70.0
Placebo to BF-200 ALA69.226.942.326.93.80.0

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Patients' Satisfaction in Follow-up (6 Months)

Patients' satisfaction of the overall cosmetic outcome was assessed at 6-months follow-up visit using a 5-point scale, where 0=very good, 1=good, 2=satisfactory, 3=unsatisfactory, and 4=impaired. The lowest rating is the best outcome, the highest rating is the worst outcome. (NCT01966120)
Timeframe: 6 months after last treatment (PDT-1 or PDT-2, if re-treated)

,
Interventionpercentage of patients (Number)
Very good or goodVery goodGoodSatisfactoryUnsatisfactoryImpaired
BF-200 ALA79.627.851.916.73.70.0
Placebo to BF-200 ALA59.333.325.925.911.13.7

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Skin Quality in Follow-up (12 Months)

"Frequency of skin quality changes in follow-up compared to baseline. Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the follow up visit (12 months) including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe." (NCT01966120)
Timeframe: 12 months after last treatment (PDT-1 or PDT-2, if re-treated)

InterventionParticipants (Count of Participants)
Skin surface (roughness/dryness/scaliness)72089484Skin surface (roughness/dryness/scaliness)72089483Hyperpigmentation (independent of texture change or hypopigmentation)72089483Hyperpigmentation (independent of texture change or hypopigmentation)72089484Hypopigmentation (independent of texture change or hyperpigmentation)72089483Hypopigmentation (independent of texture change or hyperpigmentation)72089484Mottled or irregular pigmentation (both hyper- and hypopigmentation72089483Mottled or irregular pigmentation (both hyper- and hypopigmentation72089484Degree of scarring (independent of pigmentary changes)72089483Degree of scarring (independent of pigmentary changes)72089484Atrophy72089483Atrophy72089484
MildModerateNoneSevere
BF-200 ALA39
Placebo to BF-200 ALA15
BF-200 ALA14
BF-200 ALA41
Placebo to BF-200 ALA16
BF-200 ALA13
Placebo to BF-200 ALA9
Placebo to BF-200 ALA1
BF-200 ALA48
Placebo to BF-200 ALA18
BF-200 ALA6
Placebo to BF-200 ALA7
BF-200 ALA44
Placebo to BF-200 ALA19
BF-200 ALA9
Placebo to BF-200 ALA4
BF-200 ALA1
BF-200 ALA50
Placebo to BF-200 ALA23
BF-200 ALA4
Placebo to BF-200 ALA3
BF-200 ALA52
Placebo to BF-200 ALA24
BF-200 ALA2
Placebo to BF-200 ALA2
BF-200 ALA0
Placebo to BF-200 ALA0

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Skin Quality in Follow-up (6 Months)

"Frequency of skin quality changes in follow-up compared to baseline. Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the follow up visit (6 months) including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe." (NCT01966120)
Timeframe: 6 months after last treatment (PDT-1 or PDT-2, if re-treated)

InterventionParticipants (Count of Participants)
Skin surface (roughness/dryness/scaliness)72089485Skin surface (roughness/dryness/scaliness)72089484Hyperpigmentation (independent of texture change or hypopigmentation)72089484Hyperpigmentation (independent of texture change or hypopigmentation)72089485Hypopigmentation (independent of texture change or hyperpigmentation)72089484Hypopigmentation (independent of texture change or hyperpigmentation)72089485Mottled or irregular pigmentation (both hyper- and hypopigmentation72089485Mottled or irregular pigmentation (both hyper- and hypopigmentation72089484Degree of scarring (independent of pigmentary changes)72089484Degree of scarring (independent of pigmentary changes)72089485Atrophy72089485Atrophy72089484
ModerateNoneMildSevere
BF-200 ALA34
BF-200 ALA15
BF-200 ALA4
BF-200 ALA1
BF-200 ALA35
Placebo to BF-200 ALA13
BF-200 ALA16
Placebo to BF-200 ALA10
BF-200 ALA3
BF-200 ALA42
Placebo to BF-200 ALA15
BF-200 ALA10
Placebo to BF-200 ALA9
BF-200 ALA2
Placebo to BF-200 ALA3
BF-200 ALA0
BF-200 ALA37
Placebo to BF-200 ALA14
BF-200 ALA13
BF-200 ALA44
Placebo to BF-200 ALA20
BF-200 ALA8
Placebo to BF-200 ALA5
BF-200 ALA48
Placebo to BF-200 ALA21
Placebo to BF-200 ALA4
Placebo to BF-200 ALA2
Placebo to BF-200 ALA0

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Overall Cosmetic Outcome 12 Weeks After Last PDT for Patients With Sum Score at Baseline of 0 to 3

"Study personnel assessed and recorded the skin quality of the treated field(s) at baseline and at the end-of-study visit including skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring and atrophy.~Upon visual examination of the treated field(s), the investigator coded the intensity of each skin parameter on a scale of 0 to 3, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe.~The cosmetic outcome evaluations were based on the sum score of the skin quality assessment (sum of all ratings for each skin parameter) at the end-of-study visit (Visit 4 or Visit 6, if retreated).~The outcome was calculated using a 5-point scale ranging from very good (0) to impaired (4) based on the change of the skin quality assessments compared to baseline (0 = 2 points improvement; 1 = 1 point improvement; 2 = no change; 3 = 1 point worsened; 4 = at least 2 points worsened)." (NCT01966120)
Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

,
Interventionpercentage of participants (Number)
Very goodGoodSatisfactoryUnsatisfactoryImpaired
BF-200 ALA35.224.124.111.15.6
Placebo to BF-200 ALA17.213.820.727.620.7

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Change of Total Lesion Area 12 Weeks After Last PDT

The fifth key secondary efficacy variable in the hierarchic test procedure was the change from baseline in the total lesion area per patient assessed at 12 weeks after last PDT. (NCT01966120)
Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

Interventionpercentage of lesion area change (Mean)
BF-200 ALA-98.2
Placebo to BF-200 ALA-45.5

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Lesion Complete Response 12 Weeks After Last PDT

The third key secondary efficacy variable in the hierarchic test procedure was the lesion complete response (completely cleared individual AK lesions) assessed at 12 weeks after last PDT. (NCT01966120)
Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

Interventionpercentage of lesions (Number)
BF-200 ALA94.3
Placebo to BF-200 ALA32.9

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Overall Patient Complete Response 12 Weeks After the Last PDT (PP)

"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.~Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.~The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated AK lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed." (NCT01966120)
Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

Interventionpercentage of participants (Number)
BF-200 ALA90.0
Placebo to BF-200 ALA25.9

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Overall Patient Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT)

"All efficacy variables were evaluated for the FAS. The primary efficacy variable was also analyzed for the PP population. All subgroup analyses were carried out for the FAS. Data for size and grade of AK lesions were analyzed using the last observation carried forward (LOCF) approach, affecting the response rates evaluation.~Due to the small amount of missing data in the study, which did not have any relevant impact on primary results, sensitivity analyses for missing data were not performed.~The primary efficacy variable was the overall patient complete response 12 weeks after the last PDT. An overall complete responder was defined as a patient in whom all treated actinic keratosis (AK) lesions were cleared (Olsen score of 0) after the last PDT, i.e. after PDT 1 or after PDT 2 if re-treatment was performed." (NCT01966120)
Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

Interventionpercentage of participants (Number)
BF-200 ALA90.9
Placebo to BF-200 ALA21.9

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Patient Complete Response 12 Weeks After PDT 1

The second key secondary efficacy variable in the hierarchic test procedure was the patient complete response (complete clearance of all treated AK lesions) assessed at 12 weeks after PDT 1. (NCT01966120)
Timeframe: 12 weeks after PDT 1

Interventionpercentage of participants (Number)
BF-200 ALA61.8
Placebo to BF-200 ALA9.4

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Patient Histopathological Confirmed Response Rate

"For the secondary confirmatory analysis, several superiority hypotheses were tested within a pre-defined hierarchic multiple testing procedure as described in the Statistical Analysis Protocoll (SAP).~The key secondary efficacy variables were tested strictly in a pre-defined order to ensure the family-wise error rate (FWER) and the testing procedure had to be stopped once the first non-significant test was obtained.~The results of the confirmatory analysis are presented in the order pre-defined by the confirmatory testing procedure.~Assessments of the patient histopathological confirmed response (HCR) rates were based on the results from the biopsy taken 12 weeks after the last PDT from a representative AK lesion selected at screening. If the biopsy result for a patient revealed a residual AK, the patient was considered not cleared for the analysis irrespectively of the investigator's clinical assessment." (NCT01966120)
Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

Interventionpercentage of participants (Number)
BF-200 ALA77.8
Placebo to BF-200 ALA22.2

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Patient Partial Response 12 Weeks After Last PDT

The fourth key secondary efficacy variable in the hierarchic test procedure was the patient partial response (defined as complete clearance of at least 75% of treated AK lesions) assessed at 12 weeks after last PDT. (NCT01966120)
Timeframe: 12 weeks after PDT 1 or 12 weeks after PDT 2 which might have been necessary because not all lesions were cleared after the first PDT

Interventionpercentage of participants (Number)
BF-200 ALA94.5
Placebo to BF-200 ALA25

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Lesion Recurrence Rate in Follow-up (Cumulative)

Cumulative recurrence rate in follow-up of baseline AK lesions that were cleared 12 weeks after the last treatment (PDT-1 or PDT-2, if re-treated) and recurred during 12 months follow-up. Lesions that showed recurrence at 6-months (FU1) were also defined as recurrent at 12-months follow-up (FU2). (NCT01966120)
Timeframe: 12 months after last treatment (PDT-1 or PDT-2, if retreated)

,
InterventionAK lesions (Number)
Baseline AK lesions cleared 12 weeks after last PDT with recurrence during 12 months FUBaseline AK lesions cleared 12 weeks after last PDT and are still completely cleared at 12 months FU
BF-200 ALA25251
Placebo to BF-200 ALA151

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Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules), Erythema, and Telangiectasia of Rosacea as Assessed by the Investigator's Global Assessment (IGA)

The Investigator's global assessment (IGA) of rosacea is a subjective 7-point, static scoring system. Scores range from 0 to 6: 0 (clear), 1 (minimal), 2 (mild), 3 (mild to moderate), 4 (moderate), 5 (moderate to severe), 6 (severe). (NCT02075671)
Timeframe: 17 weeks

Interventionscore on a scale (Mean)
Levulan and Blu-U Light2.8
Vehicle and Blu-U Light1.5
Vehicle Only1.5

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Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Assessed by the Inflammatory Lesion Investigator's Global Assessment (ILIGA)

The Inflammatory Lesion Investigator's Global Assessment (ILIGA) is a subjective 5-point measure of the overall disease severity. Scores range from 0 to 4: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), 4 (severe). (NCT02075671)
Timeframe: 17 weeks

Interventionscore on a scale (Mean)
Levulan and Blu-U Light1.3
Vehicle and Blu-U Light0.8
Vehicle Only1.0

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Evaluate Improvement of the Inflammatory Lesions (Papules, Pustules, Nodules) of Rosacea as Measured by a Difference in Inflammatory Lesion Count (ILC)

The Inflammatory Lesion Count (ILC) is calculated by the number of inflammatory lesions (papules, pustules, nodules) as recorded by the investigator. (NCT02075671)
Timeframe: 17 weeks

InterventionInflammatory Lesion Count (Mean)
Levulan and Blu-U Light10.8
Vehicle and Blu-U Light3.4
Vehicle Only6.2

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Evaluate Improvement of Rosacea Associated Erythema as Assessed by the Clinical Erythema Assessment (CEA) Scale

The Clinical Erythema Assessment (CEA) scale is an assessment of erythema. It has a score range from 0 to 4: 0 (none), 1 (mild), 2 (moderate), 3 (significant), 4 (severe). The total score is based on the evaluation of all areas of the face (forehead, chin, right cheek, left cheek, and nose). Each of these areas were scored from 0-4, giving a maximum total score of 20. (NCT02075671)
Timeframe: 17 weeks

Interventionscore on a scale (Mean)
Levulan and Blu-U Light6.0
Vehicle and Blu-U Light4.5
Vehicle Only1.2

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Evaluate Improvement of Rosacea as Assessed by the Patient Overall Assessment (POA) Scale

For the Patient Overall Assessments (POA) scale, patients assessed the overall improvement of their rosacea using a 4-point scale, where 1 = excellent improvement, 2 = good/moderate improvement, 3 = no change, 4 = worsening. (NCT02075671)
Timeframe: 17 weeks

Interventionscore on a scale (Mean)
Levulan and Blu-U Light0.9
Vehicle and Blu-U Light0.6
Vehicle Only0.3

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AK Clearance Rate

{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100 (NCT02137785)
Timeframe: Baseline and Week 12

Interventionpercentage of baseline lesions cleared (Mean)
ALA-PDT69.1
Vehicle29.9

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AK Clearance Rate

{1 - [(number of AK lesions at follow-up)/(number of AK lesions at Baseline)]} x 100 (NCT02137785)
Timeframe: Baseline and Week 8

Interventionpercentage of baseline lesions cleared (Mean)
ALA-PDT53.4
Vehicle26.3

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Complete Clearance Rate

proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area (NCT02137785)
Timeframe: Week 12

Interventionparticipants (Number)
ALA-PDT42
Vehicle17

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Complete Clearance Rate

proportion of subjects in each treatment group with a count of zero lesions in the Treatment Area (NCT02137785)
Timeframe: Week 8

Interventionparticipants (Number)
ALA-PDT35
Vehicle12

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02137785)
Timeframe: 12 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT1320000
Vehicle1300000

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02137785)
Timeframe: 2 weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT1314000
Vehicle1340000

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02137785)
Timeframe: 24-48 hours after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT89271810
Vehicle1330100

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02137785)
Timeframe: 4 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT1341000
Vehicle1320000

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02137785)
Timeframe: 5 minutes after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT92301030
Vehicle1277000

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02137785)
Timeframe: 8 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT1310100
Vehicle1280010

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02137785)
Timeframe: Baseline

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT1332000
Vehicle1340000

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02137785)
Timeframe: 12 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT80341530
Vehicle8536810

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02137785)
Timeframe: 2 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT284651100
Vehicle61581410

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02137785)
Timeframe: 24-48 hours after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT21648663
Vehicle64432340

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02137785)
Timeframe: 4 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT54542430
Vehicle72491100

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02137785)
Timeframe: 5 minutes after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT122643522
Vehicle57412790

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02137785)
Timeframe: 8 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT79301850
Vehicle8139720

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02137785)
Timeframe: Baseline

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT73382130
Vehicle73391930

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 12 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT52422981
Vehicle494326102

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 2 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT454633101
Vehicle58353092

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 24-48 hours after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT464928111
Vehicle583430102

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 4 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT51443091
Vehicle56372892

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 8 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT51442791
Vehicle533727102

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: Baseline

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT465127101
Vehicle533435102

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 12 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT73401630
Vehicle66451432

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 2 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT74441340
Vehicle67471442

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 24-48 hours after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT76421250
Vehicle68461442

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 4 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT76421340
Vehicle65471442

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: 8 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT75391530
Vehicle63451542

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02137785)
Timeframe: Baseline

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (light)Grade 2 (moderate - small)Grade 3 (moderate - moderate)Grade 4 (marked)
ALA-PDT75401640
Vehicle64471742

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Oozing/Vesiculation/Crusting

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02137785)
Timeframe: 12 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT1235310
Vehicle1254010

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Oozing/Vesiculation/Crusting

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02137785)
Timeframe: 2 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT92231640
Vehicle1294100

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Oozing/Vesiculation/Crusting

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02137785)
Timeframe: 24-48 hours after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT11612520
Vehicle1273310

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Oozing/Vesiculation/Crusting

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02137785)
Timeframe: 4 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT12112200
Vehicle1292100

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Oozing/Vesiculation/Crusting

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02137785)
Timeframe: 8 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT1255200
Vehicle1243200

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Oozing/Vesiculation/Crusting

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02137785)
Timeframe: Baseline

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT1287000
Vehicle1294100

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Scaling & Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02137785)
Timeframe: 12 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT8533950
Vehicle86321020

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Scaling & Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02137785)
Timeframe: 2 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT334729260
Vehicle81381140

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Scaling & Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02137785)
Timeframe: 24-48 hours after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT84301740
Vehicle79401050

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Scaling & Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02137785)
Timeframe: 4 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT73441530
Vehicle83381100

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Scaling & Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02137785)
Timeframe: 8 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT83351130
Vehicle8635530

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Scaling & Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02137785)
Timeframe: Baseline

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (minimal)Grade 2 (mild)Grade 3 (moderate)Grade 4 (severe)
ALA-PDT83351070
Vehicle78411140

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02137785)
Timeframe: 12 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-PDT130110
Vehicle130000

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02137785)
Timeframe: 2 Weeks after PDT #1

,
InterventionITT (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-PDT131301
Vehicle134000

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02137785)
Timeframe: 24-48 Hours after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-PDT1072350
Vehicle132200

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02137785)
Timeframe: 4 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-PDT132210
Vehicle132000

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02137785)
Timeframe: 5 minutes after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-PDT3070350
Vehicle130400

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02137785)
Timeframe: 8 Weeks after PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-PDT130200
Vehicle129000

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02137785)
Timeframe: Baseline

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-PDT134100
Vehicle133010

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02137785)
Timeframe: During PDT #1

,
Interventionparticipants (Number)
Grade 0 (none)Grade 1 (mild)Grade 2 (moderate)Grade 3 (severe)
ALA-PDT10397412
Vehicle1112300

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Subject Satisfaction Score

"Subject satisfaction score~= Excellent (very satisfied)~= Good (moderately satisfied)~= Fair (slightly satisfied)~= Poor (not satisfied at all)" (NCT02137785)
Timeframe: Week 12

,
Interventionparticipants (Number)
Very SatisfiedModerately SatisfiedSlightly SatisfiedNot Satisfied
ALA-PDT7147124
Vehicle29262848

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Lesion Recurrence Rate (Cumulative)

Lesion recurrence rate defined as the number of completely cleared lesions 12 weeks after the last PDT showing recurrence during FU. Overall and subgroup analysis (nodular basal cell carcinoma (nBCC) and superficial basal cell carcinoma (sBCC)). (NCT02144077)
Timeframe: 6, 12, 24, 36 and 60 months post-PDT

,
Interventionpercentage of lesions (cumulative) (Number)
OverallsBCCnBCC
BF-200 ALA13.510.325
Methyl-aminolevulinate13.411.921.4

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Lesion Complete Response Assessed 12 Weeks After the Last PDT

Lesion complete response (completely cleared individual lesions) assessed 12 weeks after the last PDT. The indicated values give percentage of overall completely cleared individual lesions. The PP set is the primary analysis set for the analysis of the secondary endpoint. (NCT02144077)
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).

InterventionPercentage of Individual Lesions (Number)
BF-200 ALA94.6
Methyl-aminolevulinate92.9

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Overall Patient Complete Response Rate Assessed 12 Weeks After the Last PDT

Overall patient complete response rate assessed 12 weeks after the last PDT. The indicated values give the percentage of overall complete responders. An overall complete responder is defined as a patient in whom all treated lesions were cleared. The PP set is the primary analysis set for the analyses of the primary endpoint. (NCT02144077)
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).

InterventionPercentage of Patients (Number)
BF-200 ALA93.4
Methyl-aminolevulinate91.8

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Patient Complete Response 12 Weeks After PDT-2

Patient complete response (complete clearance of all treated lesions) assessed 12 weeks after PDT-2 (first PDT cycle). The PP set is the primary analysis set for the analysis of the secondary endpoint. (NCT02144077)
Timeframe: 12 weeks after PDT-2 (=PDT cycle 1; please note: in this study 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).

InterventionPercentage of Patients (Number)
BF-200 ALA57.9
Methyl-aminolevulinate56.4

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Patient Recurrence Rate (Overall, Cumulative)

Patient recurrence rate defined as the number of patients with at least one recurrent lesion during FU after complete clearance 12 weeks after the last PDT (NCT02144077)
Timeframe: 6, 12, 24, 36 and 60 months post-PDT

Interventionpercentage of patients (cumulative) (Number)
BF-200 ALA16.9
Methyl-aminolevulinate15.5

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Reduction of Lesion Area 12 Weeks After the Last PDT Compared to Baseline

"Reduction of total lesion area (summation of sizes of all treated lesions) per patient, assessed 12 weeks after the last PDT. The PP set is the primary analysis set for the analysis of the secondary endpoint.~Please note that the high SD for BF-200 ALA is due to a patient who had increased lesion area fom 63 mm² at baseline to 225 mm² 12 weeks after PDT. This lesion area included a lesion that was later confirmed to be benign skin condition (lentigo solaris)." (NCT02144077)
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).

InterventionPercentage of Change (Mean)
BF-200 ALA-94.5
Methyl-aminolevulinate-97.0

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Cosmetic Outcome 12 Weeks After Last PDT (Including Patients With a Sum Score of 0 at Baseline)

"Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT:~Skin surface~Hyperpigmentation~Hypopigmentation~Mottled or irregular pigmentation~Degree of scarring~Atrophy~Cosmetic outcome categories are:~Very good: 12 weeks sum score improved by at least 2 points compared to baseline~Good: 12 weeks sum score improved by 1 point compared to baseline~Satisfactory: 12 weeks sum score identical to the one at baseline~Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline~Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline" (NCT02144077)
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).

,
InterventionPercentage of Patients (Number)
Very goodGoodSatisfactoryUnsatisfactoryImpaired
BF-200 ALA23.311.735.814.215.0
Methyl-aminolevulinate14.718.329.420.217.4

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Cosmetic Outcome 12 Weeks After the Last PDT (Including Patients With a Baseline Sum Score >1)

"Overall cosmetic outcome 12 weeks after last PDT is calculated as difference between 12 weeks after PDT sum score and baseline sum score of all skin quality assessments. Each of the below skin quality characteristics are assessed on a 4-point scale from 0 (none) to 3 (severe) by the investigator at baseline and 12 weeks after last PDT:~Skin surface~Hyperpigmentation~Hypopigmentation~Mottled or irregular pigmentation~Degree of scarring~Atrophy~Cosmetic outcome categories are:~Very good: 12 weeks sum score improved by at least 2 points compared to baseline~Good: 12 weeks sum score improved by 1 point compared to baseline~Satisfactory: 12 weeks sum score identical to the one at baseline~Unsatisfactory: 12 weeks sum score worsened by 1 point compared to baseline~Impaired: 12 weeks sum score worsened by at least 2 points compared to baseline" (NCT02144077)
Timeframe: 12 weeks after the last PDT (please note: 2 PDT cycles, each cycle consisting of 2 PDTs (= maximum of 4 PDTs per patient) was possible).

,
InterventionPercentage of Patients (Number)
Very goodGoodSatisfactoryUnsatisfactoryImpaired
BF-200 ALA40.020.022.911.45.7
Methyl-aminolevulinate21.627.032.412.26.8

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Pain Assesment (Visual Analog Scale)

Pain using visual analog scale (VAS 0-10, where 0 is no pain and 10 is the worst pain imaginable) on both treatment sides is assessed in every 30 minutes during 2-hour sun-exposure and afterwards once in two hours until 9 p.m. (treatment day). Of these values, the mean maximal pain is assessed. (NCT02149342)
Timeframe: 12 hours

InterventionMean maximal pain VAS score (Mean)
Hexylaminolaevulinate Cream0.86
Methylaminolaevulinate Cream1

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Adverse Reactions

Adverse reactions are evaluated by blinded observer at one week after treatment. Severity of the reaction ( Redness, crusting and scaling) is assessed using grading: minimal, mild, intermediate, severe. (NCT02149342)
Timeframe: One week

Interventionparticipants (Number)
Hexylaminolaevulinate Cream14
Methylaminolaevulinate Cream14

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Clinical Lesion Clearance

Clinical lesion clearance is observed by a blinded observer (NCT02149342)
Timeframe: Baseline, 3 months

Interventionpercentage of lesions in complete respon (Mean)
Hexylaminolaevulinate Cream73.4
Methylaminolaevulinate Cream77.8

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Histological Lesion Clearance

Punch biopsies were taken symmetrically on both treatment fields from equally graded >6 mm AKs prior to treatment and again at 3 months, blinded observer (pathologist). HE- and p53-stainings. Samples not fulfilling the criteria of an AK were defined as healthy or completely cleared. The p53 reactivity expressed as average percentage of positive nuclei in three consecutive high power fields from the region of highest reactivity (<10 % normal) (NCT02149342)
Timeframe: Baseline, 3 months

Interventionpercentage of complete histological clea (Mean)
Hexylaminolaevulinate Cream38.5
Methylaminolaevulinate Cream69.2

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Patient Satisfaction Survey

"Overall patient satisfaction with the technique will be assessed using a simple survey:~6 = extremely satisfied; 5 = very satisfied; 4 = somewhat satisfied; 3 = somewhat dissatisfied; 2 = very dissatisfied; 1 = extremely dissatisfied." (NCT02157623)
Timeframe: 6 months

InterventionScores on the rating scale (Mean)
Red Light Treatment5.3
Blue Light Treatment5.6

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Tumor Clearance Rate Following Red or Blue Light PDT

The rate of clearance of existing BCC tumors will be assessed in patients with BCNS, using clinical and photographic measurements. The endpoint will be assessed for tumors in a Red light treatment field and a Blue light treatment field in each patient, and compared (bilateral intrapatient comparison). (NCT02157623)
Timeframe: 6 months

InterventionPercentage of tumors cleared (Mean)
Red Light Photodynamic Therapy87.3
Blue Light Photodynamic Therapy99

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Pain During Illumination

Pain reported by the patient, using a 0-10 Visual Analog Scale (VAS), where 0 is no pain and 10 is maximum pain possible. (NCT02157623)
Timeframe: Maximum value reported during the illumination period

InterventionVAS score value (Mean)
Pain During Red Light5.6
Pain During Blue Light3.7

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Proportion of Subjects With 0 AKs

Normalized based on number of lesions present at Baseline (NCT02239679)
Timeframe: Week 52

InterventionParticipants (Count of Participants)
ALA X218
ALA X321
VEH-PDT10

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Proportion of Subjects With 0 AKs

Normalized based on number of lesions present at Baseline (NCT02239679)
Timeframe: Week 24

InterventionParticipants (Count of Participants)
ALA X230
ALA X322
VEH-PDT14

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Proportion of Subjects With 0 AKs

Normalized based on number of lesions present at Baseline (NCT02239679)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
ALA X227
ALA X335
VEH-PDT22

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Duration of Response

Duration of response is the elapsed number of weeks from the Baseline visit until a lesion recurred or Week 52, whichever comes first (NCT02239679)
Timeframe: within 52 weeks after Baseline

Interventionweeks (Mean)
ALA X235.9
ALA X333.3
VEH-PDT25.9

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Recurrence Rate

Recurrence rate of all lesions that were complete responses following on-study cryotherapy (at Visit 3/Baseline). (NCT02239679)
Timeframe: Week 52

Interventionnumber of lesions (Count of Units)
ALA X234
ALA X332
VEH-PDT81

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Total Number of AKs in Treatment Area

Count of observed lesions in the treatment area, which include lesions that recurred after on-study cryotherapy as well as newly occurring lesions. AK lesions in the treatment area at baseline (maximum of 2) were excluded for this endpoint. (NCT02239679)
Timeframe: Week 52

Interventionlesions (Least Squares Mean)
ALA X23.0
ALA X32.1
VEH-PDT4.7

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Proportion of Subjects With 0 AKs

Normalized based on number of lesions present at Baseline (NCT02239679)
Timeframe: Week 4

InterventionParticipants (Count of Participants)
ALA X235
ALA X335
VEH-PDT27

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Proportion of Subjects With 0 AKs

Normalized based on number of lesions present at Baseline (NCT02239679)
Timeframe: Week 36

InterventionParticipants (Count of Participants)
ALA X215
ALA X320
VEH-PDT10

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02281136)
Timeframe: During PDT

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3
Levulan Kerastick001910

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02281136)
Timeframe: Week 4

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3
Levulan Kerastick29000

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02281136)
Timeframe: Baseline

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3
Levulan Kerastick29000

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02281136)
Timeframe: 24 hours after PDT #1

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick409132

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02281136)
Timeframe: Week 4

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick290000

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02281136)
Timeframe: Baseline

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick290000

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02281136)
Timeframe: 5 Minutes after PDT

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick223220

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Edema

EDEMA SCALE Grade 0 = None Grade 1 = Minimal - scant, rare edema Grade 2 = Mild - easily seen edema, minimally palpable, involving up to 1/3 of the treatment area Grade 3 = Moderate - easily seen edema and typically palpable, involving between 1/3 to 2/3 of the treatment area Grade 4 = Severe - easily seen edema, indurated in some areas, involving over 2/3 of the treatment area (NCT02281136)
Timeframe: 24 hours after PDT #1

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick224200

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02281136)
Timeframe: 5 Minutes after PDT

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick007193

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02281136)
Timeframe: Baseline

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick236000

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02281136)
Timeframe: 5 Minutes after PDT

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3
Levulan Kerastick02171

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Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA

Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples wiere taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application. (NCT02281136)
Timeframe: 1 day

Interventionng/mL (Geometric Mean)
Levulan Kerastick79.85

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AUCt

AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration (NCT02281136)
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose

Interventionng*hr/mL (Geometric Mean)
Levulan Kerastick282.1

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The Terminal Exponential Half-life (T1/2,z)

The terminal slope will be calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope. (NCT02281136)
Timeframe: 1 day

Interventionhours (Geometric Mean)
Levulan Kerastick4.602

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Time at Which Cmax is Attained (Tmax) for ALA

Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16 and 24 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value. (NCT02281136)
Timeframe: 1 day

Interventionhours (Median)
Levulan Kerastick2

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Erythema

Erythema Scale - Grade 0 = None Grade 1 = Minimal - barely perceptible erythema Grade 2 = Mild - predominantly minimal erythema (pink) in the treated area with or without a few isolated areas of more intense erythema Grade 3 = Moderate - predominantly moderate erythema (red) in the treated area with or without a few isolated areas of intense erythema (bright red) Grade 4 = Severe - predominantly intense erythema (bright red) in the treated area with or without a few isolated areas of very intense (fiery red) erythema (NCT02281136)
Timeframe: Week 4

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick1271000

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02281136)
Timeframe: 24 hours after PDT

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick614440

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02281136)
Timeframe: Baseline

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick714530

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Hyperpigmentation

HYPERPIGMENTATION SCALE Grade 0 = No hyperpigmentation Grade 1 = Light hyperpigmentation involving small areas Grade 2 = Moderate hyperpigmentation involving small areas; light hyperpigmentation involving moderate areas Grade 3 = Moderate hyperpigmentation involving moderate sized areas; light hyperpigmentation involving large areas; small areas of marked hyperpigmentation Grade 4 = Marked hyperpigmentation involving moderate or large sized areas (NCT02281136)
Timeframe: Week 4

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick614630

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02281136)
Timeframe: 24 hours post PDT#1

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick918010

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02281136)
Timeframe: Baseline

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick1016300

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Hypopigmentation

HYPOPIGMENTATION SCALE Grade 0 = No hypopigmentation Grade 1 = Light hypopigmentation involving small areas Grade 2 = Moderate hypopigmentation involving small areas; light hypopigmentation involving moderate areas Grade 3 = Moderate hypopigmentation involving moderate sized areas; light hypopigmentation involving large areas; small areas of marked hypopigmentation Grade 4 = Marked hypopigmentation involving moderate or large sized areas (NCT02281136)
Timeframe: Week 4

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick821000

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OOZING/VESICULATION/CRUSTING

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02281136)
Timeframe: 24 hours after PDT #1

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick271000

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OOZING/VESICULATION/CRUSTING

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02281136)
Timeframe: Baseline

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick290000

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OOZING/VESICULATION/CRUSTING

OOZING/VESICULATION/CRUSTING Grade 0 = None Grade 1 = Minimal - a single area of oozing, vesiculation or crusting 3 mm diameter or less in size Grade 2 = Mild - two to four areas of oozing, vesiculation or crusting 3 mm diameter or less in size OR a single area larger than 3 mm diameter in size Grade 3 = Moderate - more than a single area of oozing, vesiculation or crusting larger than 3 mm diameter in size or more than four areas of 3 mm diameter or less in size Grade 4 = Severe - any degree of oozing, vesiculation or crusting greater than (3) above (NCT02281136)
Timeframe: Week 4

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick281000

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Scaling and Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02281136)
Timeframe: 24 hours after PDT #1

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick207100

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Scaling and Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02281136)
Timeframe: Baseline

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick251300

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Scaling and Dryness

SCALING AND DRYNESS SCALE Grade 0 = None Grade 1 = Minimal - barely perceptible desquamation Grade 2 = Mild - limited areas of fine desquamation in up to 1/3 of the treatment area Grade 3 = Moderate - fine desquamation involving 1/3 to 2/3 of the treatment area or limited areas of coarser scaling Grade 4 = Severe - coarser scaling involving more than 2/3 of the treatment area or limited areas of very coarse scaling (NCT02281136)
Timeframe: Week 4

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3Grade 4
Levulan Kerastick199100

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Stinging/Burning

STINGING AND BURNING SCALE Grade 0 = None Grade 1 = Minimal, barely perceptible -tolerable and little discomfort Grade 2 = Moderate - tolerable, but causes some discomfort Grade 3 = Severe - very uncomfortable or intolerable (NCT02281136)
Timeframe: 24 hours after PDT #1

Interventionparticipants (Number)
Grade 0Grade 1Grade 2Grade 3
Levulan Kerastick18910

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Average Change in Participant Reported Pain

Subject reported pain before, during and after blue light illumination was documented using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain imaginable). The maximum change in pain is 10 for each occurrence (pain before compared to during treatment and pain during compared to after treatment). This is multiplied by the number of subjects and then divided by the number of treatments to generate the range. The summation of the change between subject reported pain prior to compared to during blue light treatment was divided by the total number of treatments to obtain the average value. The summation of the change between subject reported pain during compared to after blue light treatment was divided by the total number of treatments to obtain the average value. (NCT02409732)
Timeframe: Baseline to Week 36

Interventionunits on a scale (Mean)
Avg change of pain prior to tx to during txAvg change of pain during tx to after tx
Photodynamic Therapy With Blue Light2.86-0.76

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Average Change in Local Skin Reactions to Blue Light Treatment

Assessments of swelling, erythema, and flaking/scaling were conducted after each treatment and two days post-treatment using a five-point ordinal scale (0: none to 4: severe). The average change in swelling, erythema and flaking/scaling after each treatment and two days post treatment were divided by the 50 total treatments to obtain the average value. (NCT02409732)
Timeframe: Baseline to Week 36

Interventionunits on a scale (Mean)
SwellingErythemaFlaking/Scaling (Skin Dryness)
Photodynamic Therapy With Blue Light0.720.581.82

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Number of Participants With a Change in Clearance From Baseline

Clearance will be estimated clinically as minimal (0%-25%), mild (26%-50%), moderate (51%-75%), good (76%-99%), or complete (100%). Results will also be evaluated by comparing photographs before and immediately after treatments, and 12 and 24 weeks after the last treatment. (NCT02409732)
Timeframe: Visit 2 (Baseline) to Visit 5 or 6 (Week 24 or 36)

InterventionParticipants (Count of Participants)
0% improvement at V6 (week 36)50% improvement at V6 (week 36)75% improvement at V6 (week 36)100% % improvement at V6 (week 36)Discontinued/Withdrew/Lost to follow up
Photodynamic Therapy With Blue Light11945

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Number of Participants With Adverse Events

Evaluation of any reported local or systemic events outside the treatment area and other than those specified under local skin reactions or PDT reactions. (NCT02409732)
Timeframe: Baseline to Week 36

InterventionParticipants (Count of Participants)
Upper respiratory infection (URI)Lesion on mid chestRed spotsBleeding esophageal ulcer
Photodynamic Therapy With Blue Light1111

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The Number of Participants Who Developed a Local Skin Reaction to Blue Light Treatment: Vesiculation/Pustulation, Erosion/Ulceration, Crusting and Hyperpigmentation

Assessments of vesiculation/pustulation, erosion/ulceration, and crusting were conducted immediately after each blue light treatment using a five-point ordinal scale (0: none to 4: severe). The presence or absence of hyperpigmentation in the treatment area was also documented after each treatment visit. The total number of participants who developed a local skin reaction is documented. (NCT02409732)
Timeframe: Baseline to Week 36

Interventionparticipants (Number)
Vesiculation/PustulationErosion/UlcerationCrustingHyperpigmentation
Photodynamic Therapy With Blue Light2041

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Proportion of Patients With One or More Carcinoma in Situ (CIS) Lesions Detected With Blue Light Cystoscopy With Cysview and None With White Light Cystoscopy

In the subsection of patients with histologically confirmed CIS, the proportion of patients detected only by blue light cystoscopy with Cysview is measured. (NCT02560584)
Timeframe: At time of cystoscopy procedure

InterventionParticipants (Count of Participants)
Cysview Arm9

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Proportion of Patients With Histologically Confirmed Malignancy Where Malignancy is Only Detected With Blue Light Cystoscopy With Cysview and Not White Light Cystoscopy

In the subsection of patients with histologically confirmed malignancy, the proportion of patients detected only by the use of blue light cystoscopy with Cysview is measured. (NCT02560584)
Timeframe: At time of cystoscopy procedure

InterventionParticipants (Count of Participants)
Cysview Arm13

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Visual Analog Pain Scale

"The secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the no pain anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity." (NCT02594644)
Timeframe: Immediately Post-Treatment

InterventionMillimeters (Mean)
Pain_microneedle: 10-minute Incubation With Microneedle Roller1.4
Pain_microneedle: 20-minute Incubation With Microneedle Roller1.3
Pain_microneedle: 10-minute Incubation With Microneedle Sham.3
Pain_microneedle: 20-minute Incubation With Microneedle Sham.3
Pain_PDT: 10-minute Incubation With Microneedle Sham0.3
Pain_PDT: 10-minute Incubation With Microneedle Roller.5
Pain_PDT: 20-minute Incubation With Microneedle Sham0.4
Pain_PDT: 20-minute Incubation With Microneedle Roller.7

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Difference in the Percentage of Complete Clearance of the Actinic Keratoses

The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups. (NCT02594644)
Timeframe: Baseline, 2 Months

InterventionPercentage of AK Clearance (Mean)
10-minute Incubation With Microneedle Roller43
20-minute Incubation With Microneedle Roller76
10-minute Incubation With Sham Microneedles38
20-minute Incubation With Sham Microneedles58

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AUCt/AUCBL for PpIX

The ratio of AUCt to AUCBL for PpIX (NCT02628236)
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose

Interventionratio (Geometric Mean)
ALA-PDT0.9956

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Time at Which Cmax is Attained (Tmax) for ALA

Time of the maximum baseline corrected plasma concentration for ALA measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value. (NCT02628236)
Timeframe: 2 days

Interventionhours (Median)
ALA-PDT2

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Time at Which Cmax is Attained (Tmax) for PpIX

Time of the maximum baseline corrected plasma concentration for PpIX measured at at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application.If a maximum value occurred at more than one timepoint Tmax is defined as the first timepoint with this value. (NCT02628236)
Timeframe: 2 days

Interventionhours (Median)
ALA-PDT12

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Maximum Baseline Corrected Plasma Concentration (Cmax) for PpIX

Maximum baseline corrected plasma concentration (Cmax) for PpIX over the 48 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application. (NCT02628236)
Timeframe: 2 days

Interventionng/mL (Median)
ALA-PDT0.735

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Maximum Baseline Corrected Plasma Concentration (Cmax) for ALA

Maximum baseline corrected plasma concentration (Cmax) for ALA over the 24 hour sampling time period. Blood samples were taken before ALA application and at 15 and 30 minutes, 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours following study medication application. (NCT02628236)
Timeframe: 2 days

Interventionng/mL (Geometric Mean)
ALA-PDT39.05

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AUCt for PpIX

The area under the observed plasma concentration time-curve from time 0 to the last quantifiable plasma concentration. (NCT02628236)
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose

Interventionng*hr/mL (Geometric Mean)
ALA-PDT77.00

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AUCt

AUCt is the area under the baseline corrected plasma concentration-time profile up to the last quantifiable/non-negative plasma concentration (NCT02628236)
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24 hours post-dose

Interventionng*hr/mL (Geometric Mean)
ALA-PDT182.1

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AUCBL for PpIX

The area under the concentration time-curve assuming the baseline observed plasma concentration existed from time 0 to tlast. (NCT02628236)
Timeframe: 0, 15, 30 minutes, and 1, 2, 4, 8, 12, 16, 24, 36 and 48 hours post-dose

Interventionng*hr/mL (Geometric Mean)
ALA-PDT77.34

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The Terminal Exponential Half-life (T1/2,z) for ALA

The terminal slope was calculated by linear least squares regression of the log plasma concentration-time data. The terminal exponential half-life (T1/2,z) will be calculated as 0.693 divided by the absolute value of slope. (NCT02628236)
Timeframe: 2 days

Interventionhours (Geometric Mean)
ALA-PDT5.386

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Complete Clearance Rate

Number of AK Fields with 0 lesions (NCT02632110)
Timeframe: Week 12

InterventionAK Fields (Count of Units)
MN + ALA 25 Min 10 mW16
ALA 25 Min 10 mW15
MN + ALA 25 Min 20 mW10
ALA 25 Min 20 mW12
MN + ALA 60 Min 10mW19
ALA 60 Min 10 mW15
MN + ALA 60 Min 20 mW18
ALA 60 Min 20 mW18
MN + VEH4
VEH PDT4

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Complete Clearance Rate

Number of AK Fields with 0 Lesions (NCT02632110)
Timeframe: Week 8

InterventionAK Fields (Count of Units)
MN + ALA 25 Min 10 mW5
ALA 25 Min 10 mW7
MN + ALA 25 Min 20 mW7
ALA 25 Min 20 mW7
MN + ALA 60 Min 10mW13
ALA 60 Min 10 mW11
MN + ALA 60 Min 20 mW8
ALA 60 Min 20 mW9
MN + VEH4
VEH PDT2

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Percent Change

Percent change in the total AK number as compared with Baseline (NCT02632110)
Timeframe: Baseline and Week 12

Interventionpercent change (Mean)
MN + ALA 25 Min 10 mW-87.0
ALA 25 Min 10 mW-87.3
MN + ALA 25 Min 20 mW-75.0
ALA 25 Min 20 mW-80.0
MN + ALA 60 Min 10mW-88.9
ALA 60 Min 10 mW-87.4
MN + ALA 60 Min 20 mW-95.5
ALA 60 Min 20 mW-92.6
MN + VEH-26.0
VEH PDT-18.5

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Percent Change

Percent change in the total AK number as compared with Baseline (NCT02632110)
Timeframe: Baseline and Week 8

Interventionpercent change (Mean)
MN + ALA 25 Min 10 mW-65.9
ALA 25 Min 10 mW-68.6
MN + ALA 25 Min 20 mW-64.7
ALA 25 Min 20 mW-63.4
MN + ALA 60 Min 10mW-72.9
ALA 60 Min 10 mW-69.6
MN + ALA 60 Min 20 mW-79.4
ALA 60 Min 20 mW-74.2
MN + VEH-27.9
VEH PDT-13.8

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Baseline AKCR

AK clearance rate (AKCR) for only those lesions present at Baseline (NCT02632110)
Timeframe: Baseline and Week 8

Interventionpercentage cleared (Mean)
MN + ALA 25 Min 10 mW74.5
ALA 25 Min 10 mW72.3
MN + ALA 25 Min 20 mW75.0
ALA 25 Min 20 mW69.6
MN + ALA 60 Min 10mW85.4
ALA 60 Min 10 mW83.4
MN + ALA 60 Min 20 mW86.1
ALA 60 Min 20 mW80.6
MN + VEH40.6
VEH PDT34.4

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Baseline AKCR

AK clearance rate for only those lesions present at Baseline (NCT02632110)
Timeframe: Baseline and Week 12

Interventionpercentage cleared (Mean)
MN + ALA 25 Min 10 mW92.2
ALA 25 Min 10 mW89.2
MN + ALA 25 Min 20 mW82.3
ALA 25 Min 20 mW86.7
MN + ALA 60 Min 10mW93.2
ALA 60 Min 10 mW95.1
MN + ALA 60 Min 20 mW96.3
ALA 60 Min 20 mW94.8
MN + VEH40.9
VEH PDT43.1

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Local Discomfort During Second Photodynamic Therapy (PDT-2) for Retreated Subjects

Local discomfort reported by the patients during Illumination phase of retreatment (PDT-2); only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data) (NCT02799069)
Timeframe: during PDT treatment [3 h - 4 h ]

,,
Interventionpercentage of patients (Number)
Itching during PDT-2Burning during PDT-2
BF-200 ALA7.369.9
MAL Cream8.774.7
Vehicle0.014.7

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Local Discomfort During First Photodynamic Therapy (PDT-1)

Local discomfort reported by the patients during Illumination of first PDT (PDT1) (NCT02799069)
Timeframe: during PDT treatment [3 h - 4 h ]

,,
Interventionpercentage of patients (Number)
Itching during PDT-1Burning during PDT-1
BF-200 ALA9.781.9
MAL Cream14.685.8
Vehicle2.628.9

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Adverse Reactions

"Adverse reactions are Treatment-Emergent Adverse Events considered at least possibly related to the treatment with the randomized investigational medicinal products; Adverse reactions are shown with a frequency cut off of >=5%.~TEAEs are considered from subjects who received only one PDT or subjects who received 2 PDTs (initial Treatment (PDT-1) and retreatment (PDT-2) due to remaining lesions 12 weeks after first photodynamic therapy.~The safety set consists of all patients treated at least once with investigational product. Treatment with investigational product consists of application of study drug followed by illumination. This excludes one patient from the safety set; for this patient the investigational product was applied on the skin but it was not illuminated. Patients are treated according to actual treatment." (NCT02799069)
Timeframe: up to 12 weeks after the last PDT, up to 24 weeks after first treatment

,,
InterventionParticipants (Count of Participants)
Application site irritationApplication site erythemaApplication site painApplication site edemaApplication site pruritusApplication site exfoliationApplication site scabApplication site indurationApplication site vesiclesApplication site paraesthesiaSkin exfoliation
BF-200 ALA2191981756259442724221717
MAL Cream2221991796160443021231815
Vehicle25311916520121

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Percentage of Participants With Partial Response at 3-4 Weeks After the Second Photodynamic Therapy (PDT)

"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the second PDT.~A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT." (NCT02799069)
Timeframe: 3-4 weeks after the second PDT, 15-16 weeks after first treatment

Interventionpercentage of patients (Number)
Vehicle20.5
BF-200 ALA68.0
MAL Cream62.6

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Percentage of Participants With Partial Response at 3-4 Weeks After Last Photodynamic Therapy (PDT)

"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after last PDT.~The outcome measure combined partial responders with at least 75% of lesions cleared at 3-4 weeks after the first PDT or after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT)." (NCT02799069)
Timeframe: 3-4 weeks after the last PDT, up to 16 weeks after the first treatment

Interventionpercentage of patients (Number)
Vehicle21.1
BF-200 ALA70.6
MAL Cream64.6

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Percentage of Participants With Partial Response at 3-4 Weeks After First Photodynamic Therapy (PDT)

A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 3-4 weeks after the first PDT. (NCT02799069)
Timeframe: 3-4 weeks after the first PDT

Interventionpercentage of patients (Number)
Vehicle2.6
BF-200 ALA50.0
MAL Cream45.9

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Percentage of Participants With Partial Response at 12 Weeks After the Second Photodynamic Therapy (PDT)

"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the second PDT.~A second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT." (NCT02799069)
Timeframe: 12 weeks after the second PDT, 24 weeks after first treatment

Interventionpercentage of patients (Number)
Vehicle23.3
BF-200 ALA73.4
MAL Cream65.2

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Percentage of Participants With Partial Response at 12 Weeks After the First Photodynamic Therapy (PDT)

A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after the first PDT. (NCT02799069)
Timeframe: 12 weeks after the first PDT

Interventionpercentage of patients (Number)
Vehicle13.2
BF-200 ALA58.9
MAL Cream53.3

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Percentage of Participants With Partial Response at 12 Weeks After Last Photodynamic Therapy (PDT)

"A partial responder was defined as a subject in whom at least 75% of the treated lesions were cleared (lesions showing complete remission). This outcome measure considers partial responders at 12 weeks after last PDT.~The outcome measure combined partial responders with at least 75% of lesions cleared at 12 weeks after the first PDT and after the second PDT (a second PDT was applied in case of partial- or non-responding lesions 12 weeks after the first PDT) ." (NCT02799069)
Timeframe: 12 weeks after the last PDT, up to 24 weeks after first treatment

Interventionpercentage of patients (Number)
Vehicle26.3
BF-200 ALA87.1
MAL Cream78.0

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Percentage of Participants With Complete Response 3-4 Weeks After the Second Photodynamic Therapy (PDT)

A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT. (NCT02799069)
Timeframe: 3-4 weeks after the second PDT, 15-16 weeks after first treatment

Interventionpercentage of patients (Number)
Vehicle13.7
BF-200 ALA48.4
MAL Cream43.9

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Change From Baseline in Total Lesion Area 12 Weeks After Last Photodynamic Therapy (PDT)

the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 12 weeks after last PDT, combining the changes from baseline in total lesion area at 12 weeks after the first PDT and at 12 weeks after the second PDT (a second PDT was applied to subjects with non- or partially responding lesions 12 weeks after the first PDT). (NCT02799069)
Timeframe: 12 weeks after the last PDT, up to 24 weeks after the first treatment

Interventionpercentage of change from baseline (Mean)
Vehicle-48.5
BF-200 ALA-95.0
MAL Cream-92.0

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Percentage of Participants With Complete Response 3-4 Weeks After Last Photodynamic Therapy (PDT)

A complete responder at week 3-4 after treatment was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission). This outcome measure considered patients who were completely cleared at 3-4 weeks after the last PDT which included complete responders 3-4 weeks after the first and complete responders 3-4 weeks after the second PDT ( a second PDT was applied in case of remaining lesions 12 weeks after the first PDT). (NCT02799069)
Timeframe: 3-4 weeks after the last PDT, up to 16 weeks after the first treatment

Interventionpercentage of patients (Number)
Vehicle14.5
BF-200 ALA54.0
MAL Cream43.9

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Percentage of Participants With Complete Response 3-4 Weeks After First Photodynamic Therapy (PDT)

A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 3-4 weeks after the first PDT. (NCT02799069)
Timeframe: 3-4 weeks after the first PDT

Interventionpercentage of patients (Number)
Vehicle2.6
BF-200 ALA34.7
MAL Cream24.8

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Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only

"Subgroup analysis of patients treated with a narrow spectrum device for PDT Illumination (~630 nm).~An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)" (NCT02799069)
Timeframe: 12 weeks after the last PDT, up to 24 weeks after the first treatment

Interventionpercentage of patients (Number)
Vehicle12.8
BF-200 ALA84.8
MAL Cream67.5

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Percentage of Participants With Complete Response 12 Weeks After Second Photodynamic Therapy (PDT)

A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the second PDT. A second PDT was applied in case partial- or non-responding lesions remained 12 weeks after the first PDT. (NCT02799069)
Timeframe: 12 weeks after the second PDT, 24 weeks after first treatment

Interventionpercentage of patients (Number)
Vehicle13.7
BF-200 ALA57.8
MAL Cream43.2

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Percentage of Participants With Complete Response 12 Weeks After First Photodynamic Therapy (PDT)

A complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) at 12 weeks after the first PDT. (NCT02799069)
Timeframe: 12 weeks after the first PDT

Interventionpercentage of patients (Number)
Vehicle3.9
BF-200 ALA48.4
MAL Cream37.0

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Local Discomfort - Pain During Second Photodynamic Therapy (PDT-2) for Retreated Subjects

"Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT.~Only applicable for subjects who received a retreatment (PDT-2) due to remaining lesions 12 weeks after the first treatment (PDT-1) (subjects with data)" (NCT02799069)
Timeframe: during PDT treatment [3 h - 4 h ]

Interventionunits on a scale (Mean)
Vehicle0.3
BF-200 ALA3.1
MAL Cream3.3

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Local Discomfort - Pain During First Photodynamic Therapy (PDT-1)

Pain (11-point numeric rating scale) by PDT Session; Overall (If both areas have been treated, maximum intensity over both areas is used for analysis.) Patients assessed the pain experienced during PDT using an 11-point numeric rating pain scale (NRPS) ranging from 0 (no pain at all) to 10 (worst possible pain). This score reflects the patient's maximum pain during PDT. This outcome measure shows pain score after the first PDT. (NCT02799069)
Timeframe: during PDT treatment [3 h - 4 h ]

Interventionunits on a scale (Mean)
Vehicle0.5
BF-200 ALA4.4
MAL Cream4.4

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Complete Lesion Response Rates 12 Weeks After Last Photodynamic Therapy (PDT) Illuminated With Narrow Spectrum Devices Only

"Completely cleared individual lesions 12 weeks after last PDT comprising of individual cleared lesions 12 weeks after the first or second PDT. A second PDT was applied in case individual lesion showed no or partial response 12 weeks after the first PDT.~Lesions were illuminated during photodynamic therapy with narrow spectrum devices only (~630 nm)." (NCT02799069)
Timeframe: up to 12 weeks after the last PDT, up to 24 weeks after first treatment

Interventionpercentage of lesions (Number)
Vehicle32.5
BF-200 ALA93.6
MAL Cream89.3

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Complete Lesion Response Rate 3-4 Weeks After Last Photodynamic Therapy (PDT)

Completely cleared individual lesions defined at 3-4 weeks after the last PDT comprising of completely cleared individual lesions 3-4 weeks after the first and after the second PDT (a second PDT was applied in case lesions show no or partial response 12 weeks after the first PDT). (NCT02799069)
Timeframe: 3-4 weeks after the last PDT, up to 16 weeks after first treatment

Interventionpercentage of lesions (Number)
Vehicle31.4
BF-200 ALA79.0
MAL Cream73.5

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Complete Lesion Response Rate 3-4 Weeks After First Photodynamic Therapy (PDT)

Completely cleared individual lesions as defined at 3-4 weeks after first photodynamic therapy (PDT) (NCT02799069)
Timeframe: 3-4 weeks after the first PDT

Interventionpercentage of lesions (Number)
Vehicle12.7
BF-200 ALA63.9
MAL Cream58.8

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Complete Lesion Response Rate 12 Weeks After Second PDT

Completely cleared individual lesions as defined at 12 weeks after second PDT. A second PDT was applied in case the individual lesion showed no or partial response 12 weeks after first PDT. (NCT02799069)
Timeframe: 12 weeks after the second PDT, 24 weeks after first treatment

Interventionpercentage of lesions (Number)
Vehicle22.0
BF-200 ALA69.3
MAL Cream58.0

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Complete Lesion Response Rate 12 Weeks After Last Photodynamic Therapy (PDT)

Completely cleared individual lesions 12 weeks after last PDT comprising of completely cleared individual lesions 12 weeks after the first or second PDT (a second PDT was applied in case individual lesions show no or partial response 12 weeks after first PDT). (NCT02799069)
Timeframe: 12 weeks after the last PDT, up to 24 weeks after first treatment

Interventionpercentage of lesions (Number)
Vehicle37.1
BF-200 ALA90.4
MAL Cream83.2

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Complete Lesion Response Rate 12 Weeks After First Photodynamic Therapy (PDT)

Completely cleared individual lesions as defined at 12 weeks after the first photodynamic therapy (PDT). (NCT02799069)
Timeframe: 12 weeks after the first PDT

Interventionpercentage of lesions (Number)
Vehicle24.7
BF-200 ALA73.8
MAL Cream66.5

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Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), ITT

"An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)" (NCT02799069)
Timeframe: 12 weeks after the last PDT, up to 24 weeks after the first treatment

Interventionpercentage of patients (Number)
Vehicle17.1
BF-200 ALA78.2
MAL Cream64.2

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Change From Baseline in Total Lesion Area 3-4 Weeks After the Second Photodynamic Therapy (PDT)

the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 3-4 weeks after the second PDT. A second PDT was applied in case of non or partially responding lesions 12 weeks after first PDT. (NCT02799069)
Timeframe: 3-4 weeks after the second PDT, 15-16 weeks after first treatment

Interventionpercentage of change from baseline (Mean)
Vehicle-46.2
BF-200 ALA-91.4
MAL Cream-87.5

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Change From Baseline in Total Lesion Area 3-4 Weeks After the First Photodynamic Therapy (PDT)

Percentage of change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after the first PDT. (NCT02799069)
Timeframe: 3-4 weeks after the first PDT

Interventionpercentage of change from baseline (Mean)
Vehicle-26.9
BF-200 ALA-78.9
MAL Cream-75.7

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Change From Baseline in Total Lesion Area 3-4 Weeks After Last Photodynamic Therapy (PDT)

the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed at 3-4 weeks after last PDT, combining the changes from baseline in total lesion area of subjects 3-4 weeks after first PDT and second PDT (a second PDT was applied for subjects who showed non- or partially responding lesions 12 weeks after the first PDT). (NCT02799069)
Timeframe: 3-4 weeks after the last PDT, up to 16 weeks after the first treatment

Interventionpercentage of change from baseline (Mean)
Vehicle-43.8
BF-200 ALA-89.4
MAL Cream-86.6

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Change From Baseline in Total Lesion Area 12 Weeks After the First Photodynamic Therapy (PDT)

the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the first PDT. (NCT02799069)
Timeframe: 12 weeks after the first PDT

Interventionpercentage of change from baseline (Mean)
Vehicle-37.0
BF-200 ALA-85.4
MAL Cream-80.9

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Change From Baseline in Total Lesion Area 12 Weeks After Second Photodynamic Therapy (PDT)

the change from baseline in the lesion area of all treated lesions per subject (summation of sizes of all treated lesions) assessed 12 weeks after the second PDT. A second PDT was applied in case of non- or partially responding lesions 12 weeks after first PDT. (NCT02799069)
Timeframe: 12 weeks after the second PDT, 24 after first treatment

Interventionpercentage of change from baseline (Mean)
Vehicle-50.1
BF-200 ALA-92.3
MAL Cream-88.9

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Percentage of Participants With Complete Response 12 Weeks After the Last Photodynamic Therapy (PDT), PP

"An overall complete responder was defined as a subject in whom all treated lesions were cleared (all lesions showing complete remission) 12 weeks after the last PDT.~The outcome measure considered complete responders who were completely cleared 12 weeks after the first PDT and responders who were completely cleared 12 weeks after the second PDT if a re-treatment was necessary (in case of partial- or non-responding lesions 12 weeks after the first PDT)" (NCT02799069)
Timeframe: 12 weeks after the last PDT, up to 24 weeks after the first treatment

Interventionpercentage of patients (Number)
Vehicle20.0
BF-200 ALA79.4
MAL Cream65.3

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Complete Lesion Response Rate 3-4 Weeks After the Second Photodynamic Therapy (PDT)

Completely cleared individual lesions as defined at 3-4 weeks after the second PDT. A second PDT was applied in case the individual lesion showed no or partial response12 weeks after first PDT. (NCT02799069)
Timeframe: 3-4 weeks after the second PDT, 15-16 weeks after first treatment

Interventionpercentage of lesions (Number)
Vehicle16.3
BF-200 ALA60.4
MAL Cream54.8

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Overall Cosmetic Outcome of the Treated Skin 12 Weeks After Last Photodynamic Therapy (PDT) Compared to Baseline

The cosmetic outcome 12 weeks after the last PDT (12 weeks after 1st PDT for subjects who are completely cleared at this time point, 12 weeks after 2nd PDT for subjects retreated due to remaining lesions 12 weeks after 1st PDT) will be calculated on the basis of the skin quality assessment (skin surface, hyperpigmentation, hypopigmentation, mottled or irregular pigmentation, degree of scarring, and atrophy) upon visual examination (scale: 0= none, 1= mild, 2= moderate, 3=severe). The cosmetic outcome is rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; as good if the sum score has improved by at least 1 point as compared to baseline; as satisfactory if the sum score is identical to the one at baseline; as unsatisfactory if the sum score has worsened by 1 point compared to baseline and as impaired if the sum score has worsened by at least 2 points compared to baseline. (NCT02799069)
Timeframe: 12 weeks after the last PDT, up to 24 weeks after first treatment

,,
Interventionpercentage of patients (Number)
very good or goodvery goodgoodSatisfactoryUnsatisfactoryImpaired
BF-200 ALA36.016.519.455.86.61.7
MAL Cream37.119.217.953.35.83.8
Vehicle29.414.714.750.016.24.4

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Local Skin Reactions During Second Photodynamic Therapy (PDT-2) for Retreated Subjects

Local skin reactions in the treatment area as assessed by the investigator during PDT-2; only applicable for subjects who were retreated with a second PDT due to remaining lesions 12 weeks after the first PDT (subjects with data). (NCT02799069)
Timeframe: during PDT treatment [3 h - 4 h ]

,,
Interventionpercentage of patients (Number)
ErythemaEdemaIndurationVesiclesErosionUlcerationScaling/FlakingScabbing/CrustingWeeping/Exudate
BF-200 ALA61.810.64.10.00.00.00.00.00.0
MAL Cream70.011.33.30.00.00.00.00.00.0
Vehicle19.10.00.00.00.00.00.00.00.0

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Local Skin Reactions During First Photodynamic Therapy (PDT-1)

Local skin reactions in the treatment area as assessed by the investigator during the first PDT (PDT-1) (NCT02799069)
Timeframe: during PDT treatment [3 h - 4 h ]

,,
Interventionpercentage of patients (Number)
ErythemaEdemaIndurationVesiclesErosionUlcerationScaling/FlakingScabbing/CrustingWeeping/Exudate
BF-200 ALA72.622.29.33.21.20.00.40.40.4
MAL Cream71.123.68.56.11.20.00.00.01.2
Vehicle32.91.30.00.00.00.00.00.00.0

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Overall Cosmetic Outcome 12 Weeks After the Last PDT

Overall Cosmetic Outcome (CO) 12 weeks after PDT (12 weeks after 1st PDT or 12 weeks after 2nd PDT). The cosmetic outcome at the end-of-study visit was calculated on the basis of skin quality assessment: skin surface, hyperpigmentation, hypopigmentation, mottled/irregular pigmentation, degree of scarring, and atrophy. The CO was rated as very good if the sum score of the previously mentioned ratings (all ratings for each sign added up) has improved by at least 2 points as compared to baseline; the CO was rated as good if the sum score at a given visit has improved by at least 1 point as compared to baseline; the cosmetic outcome is rated as satisfactory if the sum score at a given visit is identical to the one at baseline; the cosmetic outcome is rated as unsatisfactory if the sum score at a given visit has worsened by 1 point compared to baseline, the cosmetic outcome is rated as impaired if the sum score at a given visit has worsened by at least 2 points compared to baseline. (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

,
InterventionParticipants (Count of Participants)
very goodgoodsatisfactoryunsatisfactoryimpaired
BF-200 ALA19193921
Vehicle462154

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Local Skin Reactions

Local skin reactions observed immediately after illumination by the investigator were documented using different categories (erythema, edema, induration, vesicles, erosion, ulceration, scaling/flanking, scabbing/crusting,weeping/exudates). (NCT02799082)
Timeframe: during and after PDT [3h - 4 h]

,
InterventionParticipants (Count of Participants)
erythemaedemaindurationvesicleserosionulcerationscaling/flakingscabbing/crustingweeping/exudate
BF-200 ALA723212000320
Vehicle1510000000

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Discomfort During and After PDT

Local discomfort experienced by the patient after illumination were documented in three categories: itching, burning, pain. (NCT02799082)
Timeframe: during and after PDT [3h - 4 h]

,
InterventionParticipants (Count of Participants)
painitchingburning
BF-200 ALA442370
Vehicle4010

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Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)

"AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~Analysis was for the subgroup: treated by narrow spectrum lamps only [n=15 (vehicle), n= 31 (BF-200 ALA)]" (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionpercentage of participants (Number)
Vehicle13.3
BF-200 ALA87.1

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Total Patient Clearance Rate Treated With Narrow Spectrum Lamp 12 Weeks After the Last Photodynamic Therapy (PDT)

"AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~Analysis was for the subgroup: treated by narrow spectrum lamps only [n=13 (vehicle), n= 28 (BF-200 ALA)]" (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionpercentage of patients (Number)
Vehicle15.4
BF-200 ALA96.4

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Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)

AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). (NCT02799082)
Timeframe: 12 weeks after the last photodynamic therapy (PDT), up to 24 weeks

Interventionpercentage of participants (Number)
Vehicle12.5
BF-200 ALA66.3

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Total Patient Clearance Rate 12 Weeks After the Last Photodynamic Therapy (PDT)

AK clearance rate, defined as the percentage of subjects with complete remission of all AK lesions in the target area(s) assessed 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionpercentage of participants (Number)
Vehicle10.8
BF-200 ALA63.6

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Subjects With Partial Clearance 12 Weeks After the Last PDT

Percentage of subjects with clearance of at least 75% of lesions 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionpercentage of patients (Number)
Vehicle17.5
BF-200 ALA78.8

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Subjects With Complete Clearance 12 Weeks After the First PDT

AK clearance rate, defined as the number of subjects with complete remission of all AK lesions assessed at 12 weeks after the first PDT (NCT02799082)
Timeframe: 12 weeks after the first PDT

Interventionpercentage of patients (Number)
Vehicle10.0
BF-200 ALA47.5

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Percentage of AK Lesions Showing Complete Remission 12 Weeks After the Last PDT

Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment); Overall population (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionpercentage of lesions (Number)
Vehicle20.9
BF-200 ALA81.1

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Change in Total Lesion Size 12 Weeks After the Last PDT

"Change in the mean total lesion area 12 weeks per subject after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline." (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionmm² (Mean)
Vehicle-110.3
BF-200 ALA-360.2

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Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Scalp)

"Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.~Subgroup Analysis for patients with lesions located in the scalp only." (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionmm² (Mean)
Vehicle-112.3
BF-200 ALA-340.2

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Change in Total Lesion Area 12 Weeks After the Last PDT (Treated Area Face)

"Change in mean total lesion area within the target treatment area per subject 12 weeks after the last PDT compared to baseline (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment). The outcome measure describes the mean difference between total lesion size at baseline and 12 weeks after the last PDT. Negative values indicate a reduction in the total lesion area size compared to baseline.~Subgroup Analysis for patients with lesions located in the face only." (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionmm² (Mean)
Vehicle-94.1
BF-200 ALA-315.0

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Percentage of AK Lesions Showing Complete Remission Treated With Narrow Spectrum Lamp 12 Weeks After the Last PDT

"Percentage of individual lesions completely cleared and with no adherent scaling plaques of AK that were visible any longer 12 weeks after the last PDT (12 weeks after the 1st PDT or 12 weeks after the 2nd PDT in case of retreatment).~for subgroup analysis: patients treated with narrow spectrum lamp only." (NCT02799082)
Timeframe: 12 weeks after the last PDT, up to 24 weeks

Interventionpercentage of lesions (Number)
Vehicle15.1
BF-200 ALA96.3

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Percent Change in AK Lesion Count

The number of actinic keratoses within the treatment area was counted both pre and post-treatment. Then, the mean percent change from baseline actinic keratosis lesion count was calculated for each treatment group. (NCT03322293)
Timeframe: 12 weeks

Interventionpercent change (Mean)
A. Conventional Arm63.9
B. Combination Arm66.4
C. Daylight Arm61.8

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Peak Pain Score at Day 8 Post-treatment

Pain was measured by patient report with a visual analog scale from 0-10. 0 indicates no pain and 10 indicates the maximum pain score. (NCT03322293)
Timeframe: 8 days post-treatment

Interventionscore on a scale (Mean)
A. Conventional Arm3.5
B. Combination Arm5.13
C. Daylight Arm4.00

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Change in Treatment Symptoms

Primary objective is to determine whether daylight PDT changes treatment symptoms of pain, stinging/burning, and itching/pruritus. This was measured using a visual analog scale from 0-10, with higher scores indicating worse treatment symptoms, or more pain/burning/itching. Lower scores indicate less pain, burning/stinging, and itching/pruritus. Positive numbers represent increases in symptoms and negative numbers represent decreases. (NCT03322293)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
A. Conventional Arm3.9
B. Combination Arm0.5
C. Daylight Arm0.37

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Reduction of AK Counts

The number of AK lesions within the treatment area was assessed both pre and post-treatment. Then, the number of participants with various levels of AK lesion reduction (100% reduction or greater than 75% reduction) was calculated for each treatment group. This outcome measures the proportion of subjects with complete (100%) and partial (greater than or equal to 75%) reduction of baseline actinic keratosis lesion counts at 12 weeks (study end). (NCT03322293)
Timeframe: 12 weeks

,,
InterventionParticipants (Count of Participants)
Partial ClearanceComplete Clearance
A. Conventional Arm22
B. Combination Arm32
C. Daylight Arm52

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Change in Local Skin Reaction From Pre-treatment to 12 Weeks Post-treatment

To determine whether daylight PDT affords a reduction in local skin reaction to treatment. A Local Skin Response Assessment scale will be used to measure this outcome. The investigators will grade categories including Erythema, Flaking/Scaling, crusting, swelling, Pustulation (pustules), and Erosion, on a 0-4 scale (total maximum score of 24). A higher score indicates more erythema, flaking, crusting, etc. and therefore a more robust skin reaction. A score of 0 represents no erythema, flaking, crusting, etc. (NCT03322293)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
A. Conventional Arm1.0
B. Combination Arm1.25
C. Daylight Arm1.0

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Overall Subject Satisfaction at Week 12 Post-treatment

Percentage of subjects satisfied or very satisfied (overall) with Luxerm DL procedure (NCT03511326)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
Luxerm®41

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Overall Subject Satisfaction the Day of Treatment After Daylight Session

Percentage of subjects satisfied and very satisfied globally with Luxerm Daylight procedure, the day of treatment after daylight session (NCT03511326)
Timeframe: the day of treatment after daylight session

InterventionParticipants (Count of Participants)
Luxerm®47

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Number of Participants With no Residual Tumor Following Photodynamic Therapy (PDT)

Histologically confirmed the absence of residual disease at follow-up lesion site biopsy (7 days) and from additional clinical examinations during follow-up visits. The follow-up visits happened approximately once every 3 months after treatment until Institutional Review Board (IRB) approval (October 12, 2020). (NCT03638622)
Timeframe: Up to 2 years

InterventionParticipants (Count of Participants)
Aminolevulinic Acid (ALA) Photodynamic Therapy (PDT)22

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

Parameter: AUC(0-∞) (Area Under Curve); area under the baseline-adjusted plasma concentration-time data extrapolated to infinity (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionh*ng/mL (Geometric Mean)
Stratum: Face/Scalp138.41
Stratum: Periphery138.55

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

Parameter: Cmax (Maximum Plasma Concentration); observed maximum baseline-adjusted plasma concentration (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionng/mL (Geometric Mean)
Stratum: Face/Scalp27.93
Stratum: Periphery27.68

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

Parameter: t1/2 (apparent terminal half-life); calculated by ln2/λz; t1/2 was only determined in subjects in which the log-linear terminal phase could clearly be defined. Resulting unreliable parameters were flagged accordingly and not used in descriptive statistics. If any pharmacokinetic parameter should have been classified as unreliable, all calculations that use this parameter were considered missing. (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionh (Geometric Mean)
Stratum: Face/Scalp2.86
Stratum: Periphery1.93

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

Parameter: Tmax (time to reach Cmax) (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionh (Median)
Stratum: Face/Scalp3.0
Stratum: Periphery3.42

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

Parameter: λz (Elimination Rate Constant); λz denotes the terminal rate constant estimated by linear regression analysis from a range of concentrations in the terminal phase estimated for each treatment and subject by log-linear regression from the linear portion of the logarithmic transformed concentration-time plot. The algorithm will start with the last 3 points with quantifiable concentrations and increases the number of involved points by 1 until the time point after Cmax restricted on time points after removing of the BF-200 ALA gel (all PK samples after the gel is wiped off [after 3h±10 min); λz was only determined in subjects in which the log-linear terminal phase could clearly be defined. Resulting unreliable parameters were flagged accordingly and not used in descriptive statistics. If any pharmacokinetic parameter should have been classified as unreliable, all calculations that use this parameter were considered missing. (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Intervention1/h (Geometric Mean)
Stratum: Face/Scalp0.24
Stratum: Periphery0.36

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.

Parameter: %AUC(t-∞) (Area Under Curve); proportion of extrapolated part (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionpercentage of AUC (0-∞) (Geometric Mean)
Stratum: Periphery7.33

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Assessment of the Frequency and Severity of All Treatment-emergent Adverse Events (TEAEs), Including Serious Adverse Events (SAEs) in Response to PDT With BF-200 ALA Under Maximal Use Conditions.

Frequency of treatment-emergent adverse events (TEAEs),including serious adverse events (SAEs). (NCT04319159)
Timeframe: On treatment day until end of study approximately 4 weeks after treatment day (day 0)

,
InterventionParticipants (Count of Participants)
Application site erythemaApplication site exfoliationApplication site hyperaesthesiaApplication site indurationApplication site oedemaApplication site painApplication site paraesthesiaApplication site pruritusApplication site scabApplication site vesiclesApplication site warmth
Stratum: Face/Scalp161022161644514
Stratum: Periphery1632291616621

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Assessment of Frequency and Severity of Application Site Skin Reactions in Response to PDT With BF-200 ALA Under Maximal Use Conditions.

Application site reactions: skin reactions (erythema, edema, induration, vesicles, erosion, ulceration, scaling/flaking, scabbing/crusting, discharge/exudate, others); maximum severity of AE: mild, moderate, or severe (NCT04319159)
Timeframe: On treatment day until end of study approximately 4 weeks after treatment day (day 0)

,
InterventionParticipants (Count of Participants)
Discharge/exudateOedemaErythemaIndurationOtherScabbing/crustingScaling/flaking
Stratum: Face/Scalp1161621252
Stratum: Periphery09162463

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Assessment of Baseline-adjusted Plasma Concentration-time Curves for PpIX After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.

Blood samples for PpIX analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of PpIX in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods. (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

,
Interventionng/mL (Geometric Mean)
0.5h1h1.5h2h2.5h3h3.5h4h5h6h8h10h
Stratum: Face/Scalp0.28200.30780.21760.14970.16340.13690.23130.20210.26310.30910.40320.7918
Stratum: Periphery0.21990.19570.30220.22650.33890.19720.23340.35220.23440.20760.18630.06873

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Assessment of Baseline-adjusted Plasma Concentration-time Curves for ALA After a Single PDT Treatment Applying 3 Tubes of BF-200 ALA in Conjunction With the BF-RhodoLED® Under Maximal Use Conditions in Subjects With Mild to Severe Actinic Keratosis.

Blood samples for ALA analysis for each subject were collected, starting at Visit 1 and then 0.5h prior to BF-200 ALA application for up to 10h afterwards. The concentrations of ALA in plasma were measured by an analytical laboratory using validated, internally standardized liquid chromatography-tandem mass spectrometry methods. (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

,
Interventionng/mL (Geometric Mean)
0.5h1h1.5h2h2.5h3h3.5h4h5h6h8h10h
Stratum: Face/Scalp8.90412.4518.9618.0223.0624.7122.0016.5410.215.8123.2502.536
Stratum: Periphery10.219.38310.159.5616.23313.5510.777.1724.5584.2312.8713.444

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

Parameter: AUC(0-t) (Area Under Curve); area under the baseline-adjusted plasma concentration-time curve from time zero to the last sampling time point at which the concentration was at or above lower limit of quantification; t(last) is defined as the last value >0 after baseline adjustment. (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionh*ng/mL (Geometric Mean)
Stratum: Face/Scalp110.03
Stratum: Periphery71.12

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.

Parameter: λz (Elimination Rate Constant); λz denotes the terminal rate constant estimated by linear regression analysis from a range of concentrations in the terminal phase estimated for each treatment and subject by log-linear regression from the linear portion of the logarithmic transformed concentration-time plot. The algorithm will start with the last 3 points with quantifiable concentrations and increases the number of involved points by 1 until the time point after Cmax restricted on time points after removing of the BF-200 ALA gel (all PK samples after the gel is wiped off [after 3h±10 min); λz was only determined in subjects in which the log-linear terminal phase could clearly be defined. Resulting unreliable parameters were flagged accordingly and not used in descriptive statistics. If any pharmacokinetic parameter should have been classified as unreliable, all calculations that use this parameter were considered missing. (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Intervention1/h (Geometric Mean)
Stratum: Periphery0.35

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Assessment of Frequency and Severity of Application Site Discomfort in Response to PDT With BF-200 ALA Under Maximal Use Conditions.

Application site reactions: discomfort (burning, pain, itching, stinging, warmth, others) (NCT04319159)
Timeframe: On treatment day until end of study approximately 4 weeks after treatment day (day 0)

,
InterventionParticipants (Count of Participants)
BurningItchingOtherPainPain during PDTStingingWarmth
Stratum: Face/Scalp1448151674
Stratum: Periphery96171631

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.

Parameter: t1/2 (apparent terminal half-life); calculated by ln2/λz; t1/2 was only determined in subjects in which the log-linear terminal phase could clearly be defined. Resulting unreliable parameters were flagged accordingly and not used in descriptive statistics. If any pharmacokinetic parameter should have been classified as unreliable, all calculations that use this parameter were considered missing. (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionh (Geometric Mean)
Stratum: Periphery1.95

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.

Parameter: Tmax (time to reach Cmax) (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionh (Median)
Stratum: Face/Scalp4.0
Stratum: Periphery3.52

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"Assessment of Pain Intensity at the Application Site in Response to PDT With BF-200 ALA Under Maximal Use Conditions Using an 11-point Numeric Rating Scale (NRS-11), Where a Score of 0 Means no Pain and a Score of 10 Means Worst Imaginable Pain."

Assessment of pain at the application site using an 11-point Numeric Rating Scale (NRS-11) ranging from 0 (no pain) to 10 (worst imaginable pain) (NCT04319159)
Timeframe: On treatment day until end of study approximately 4 weeks after treatment day (day 0)

Interventionscore on a scale (Mean)
Stratum: Face/Scalp8.1
Stratum: Periphery6.0

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.

Parameter: AUC(0-t) (Area Under Curve); area under the baseline-adjusted plasma concentration-time curve from time zero to the last sampling time point at which the concentration was at or above lower limit of quantification; t(last) is defined as the last value >0 after baseline adjustment. (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionh*ng/mL (Geometric Mean)
Stratum: Face/Scalp0.88
Stratum: Periphery0.68

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.

Parameter: AUC(0-∞) (Area Under Curve); area under the baseline-adjusted plasma concentration-time data extrapolated to infinity (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionh*ng/mL (Geometric Mean)
Stratum: Periphery0.77

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of ALA.

Parameter: %AUC(t-∞) (Area Under Curve); proportion of extrapolated part (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionpercentage of AUC (0-∞) (Geometric Mean)
Stratum: Face/Scalp8.27
Stratum: Periphery3.01

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Evaluation of Baseline-adjusted Pharmacokinetic Parameters of PpIX.

Parameter: Cmax (Maximum Plasma Concentration); observed maximum baseline-adjusted plasma concentration (NCT04319159)
Timeframe: On treatment day (day 0): 0.5, 1, 1.5, 2, 2.5, 3*, 3.5, 4, 5, 6, 8, 10 hours post-dose (*prior to illumination)

Interventionng/mL (Geometric Mean)
Stratum: Face/Scalp0.48
Stratum: Periphery0.34

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