Page last updated: 2024-12-08

methyl 5-aminolevulinate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

methyl 5-aminolevulinate: esterified form of aminolevulinic acid used as PHOTOCHEMOTHERAPY [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

methyl 5-aminolevulinate : The methyl ester of 5-aminolevulinic acid. A prodrug, it is metabolised to protoporphyrin IX, a photosensitizer, and is used in the photodynamic treatment of non-melanoma skin cancer (including basal cell carcinoma). Topical application (often as the hydrochloride salt) results in an accumulation of protoporphyrin IX in the skin lesions to which the cream has been applied. Subsequent illumination with red light results in the generation of toxic singlet oxygen that destroys cell membranes and thereby kills the tumour cells. [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]

Cross-References

ID SourceID
PubMed CID157922
CHEMBL ID1096562
CHEBI ID724125
SCHEMBL ID8521
MeSH IDM0451457

Synonyms (41)

Synonym
unii-585nm85kym
585nm85kym ,
methyl aminolevulinate
methyl 5-aminolevulinate
methyl delta-aminolevulinate
aminolevulinic acid methyl ester
DB00992
5-aminolevulinic acid methyl ester
pentanoic acid, 5-amino-4-oxo-, methyl ester
NCGC00018251-01
metvix
levulinic acid, 5-amino-, methyl ester
methyl 5-amino-4-oxopentanoate
CHEBI:724125 ,
D08204
33320-16-0
methyl aminolaevulinate
methyl-5-aminolevulinate
CHEMBL1096562
methylaminolevulinate
NCGC00018251-04
NCGC00018251-02
maop cpd
5-amino-4-oxo-pentanoic acid methyl ester
AKOS006220489
methyl aminolevulinate [who-dd]
methyl aminolevulinate [mi]
methyl aminolevulinate [vandf]
SCHEMBL8521
YUUAYBAIHCDHHD-UHFFFAOYSA-N
DTXSID3048570
NCGC00018251-05
d-aminolevulinicacidmethylesterhydrochloride
5-aminolavulinsauremethylester
methyl5-amino-4-oxopentanoate
FT-0760150
Q619603
HY-A0169
methyl-aminolevulinate
CS-0017508
EN300-245968

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" 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
" 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

Compound-Compound Interactions

ExcerptReferenceRelevance
" 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
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
antineoplastic agentA substance that inhibits or prevents the proliferation of neoplasms.
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.
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
dermatologic drugA drug used to treat or prevent skin disorders or for the routine care of skin.
[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 (1)

ClassDescription
delta-amino acid esterAny ester of a delta-amino acid.
[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]

Bioassays (51)

Assay IDTitleYearJournalArticle
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
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.
AID1564459Prodrug activation in human HeLa cells assessed as increase in GSH-mediated PpIX production at 1000 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.
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.
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.
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).
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.
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.
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).
AID519390Antibacterial activity against Escherichia coli K-12 assessed as reduction in microbial viability incubated at 30 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.
AID519401Antibacterial activity against Pseudomonas aeruginosa 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.
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).
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.
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.
AID1304423Antitumor activity against human A431 cells ectopically xenografted in topically dosed SCID mouse assessed as tumor growth pretreated for 4 hrs via Metvix cream followed by 220 J/cm'-2 ultrasound irradiation measured on day 7 post dosing relative to contr2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Comparing the efficacy of photodynamic and sonodynamic therapy in non-melanoma and melanoma skin cancer.
AID1304424Antitumor activity against human A431 cells ectopically xenografted in topically dosed SCID mouse assessed as tumor growth treated for 4 hrs via Metvix cream measured on day 7 post dosing 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.
AID1304426Toxicity in topically dosed SCID mouse xenografted ectopically with human A431 cells assessed as reduction in body weight pretreated for 4 hrs via Metvix cream followed by 220 J/cm'-2 ultrasound irradiation measured on day 7 post dosing2016Bioorganic & 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).
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).
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.
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.
AID519403Induction of photoactive porphyrins in Escherichia coli Ti05 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.
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.
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.
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.
AID519384Induction of photoactive porphyrins in Escherichia coli K-12 assessed as porphyrin 7-CP 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.
AID519385Induction of photoactive porphyrins in Escherichia coli K-12 assessed as porphyrin 6-CP 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.
AID519388Antibacterial activity against Escherichia coli K-12 assessed as reduction in microbial viability incubated at 10 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.
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).
AID519404Induction 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.
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).
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).
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.
AID519494Induction of photoactive porphyrins in Escherichia coli K-12 assessed as porphyrin 5-CP 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.
AID519399Antibacterial activity against Escherichia coli K-12 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.
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.
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).
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.
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).
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).
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).
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).
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.
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).
AID1304425Toxicity in topically dosed SCID mouse xenografted ectopically with human A431 cells assessed as reduction in body weight pretreated for 4 hrs via Metvix cream followed by 40 J/cm'-2 red light irradiation measured on day 7 post dosing2016Bioorganic & medicinal chemistry, 07-01, Volume: 24, Issue:13
Comparing the efficacy of photodynamic and sonodynamic therapy in non-melanoma and melanoma skin cancer.
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.
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.
AID1304422Antitumor activity against human A431 cells ectopically xenografted in topically dosed SCID mouse assessed as tumor growth pretreated for 4 hrs via Metvix cream followed by 40 J/cm'-2 red light irradiation measured on day 7 post dosing 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.
AID519400Antibacterial activity against Escherichia coli Ti05 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.
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.
AID519402Induction of photoactive porphyrins in Escherichia coli K-12 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.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (479)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's130 (27.14)29.6817
2010's318 (66.39)24.3611
2020's31 (6.47)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 13.39

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 weak demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index13.39 (24.57)
Research Supply Index6.52 (2.92)
Research Growth Index4.73 (4.65)
Search Engine Demand Index10.37 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (13.39)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials152 (29.01%)5.53%
Reviews63 (12.02%)6.00%
Case Studies92 (17.56%)4.05%
Observational11 (2.10%)0.25%
Other206 (39.31%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (47)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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
Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study [NCT02392390]10 participants (Actual)Interventional2015-10-31Completed
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 Randomized, Prospective Study Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Ablative Fractional Laser Treatment for Actinic Cheilitis [NCT02198469]Phase 133 participants (Actual)Interventional2012-01-31Completed
Topical Ingenol Mebutate Versus 5% 5-fluorouracil Versus 5% Imiquimod Versus Photodynamic Therapy in Treatment of Actinic Keratosis: a Multi-centre Randomized Efficacy and Cost-effectiveness Study [NCT02281682]Phase 4624 participants (Actual)Interventional2014-11-30Active, not recruiting
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
New Treatments for Actinic Keratoses of the Scalp [NCT05456334]120 participants (Anticipated)Interventional2016-03-24Active, not recruiting
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 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
Clinical Evaluation of a Short Illumination Duration (35 Minutes) When Performing Photodynamic Therapy of Actinic Keratosis Using the Dermaris ® [NCT05522036]25 participants (Actual)Interventional2022-01-01Completed
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
[NCT00711178]150 participants (Anticipated)Interventional2008-06-30Completed
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
Prospective, Randomized, Controlled, Multicenter, Two-armed, Study Comparing Daylight Photodynamic Therapy Using MAL With Cryosurgery for the Treatment and Prophylaxis of Actinic Keratoses in Photodamaged Skin of the Face [NCT02736760]Phase 458 participants (Actual)Interventional2016-03-03Completed
A Randomized, Intra-individual, Prospective Study Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Er:YAG Ablative Fractional Laser Treatment in Asian Patients With Lower Extremity Bowen's Disease [NCT01912976]Phase 121 participants (Actual)Interventional2011-03-31Completed
Gene Expression in Renal Transplant Patients With Field Actinic Keratosis Undergoing Metvix® PDT [NCT01000636]Phase 49 participants (Actual)Interventional2009-10-31Completed
Observational Study to Evaluate Clinical Practice and Satisfaction With Metvix® Daylight Photodynamic Therapy (PDT) in the Treatment of Mild and/or Moderate Actinic Keratosis of the Face and/or the Scalp [NCT02674048]406 participants (Actual)Observational2015-09-30Completed
A Multicenter, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma [NCT00472108]Phase 365 participants (Actual)Interventional2000-12-31Completed
A Multicentre, Randomised Study of Photodynamic Therapy(PDT) With Metvix® 160 mg/g Cream in Immuno-compromised Patients With Non-melanoma Skin Cancer [NCT00472459]Phase 381 participants (Actual)Interventional2003-07-31Completed
Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis [NCT03013647]20 participants (Anticipated)Interventional2016-09-30Recruiting
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
A Multicentre, Phase III, Double Blind Study of Photodynamic Therapy (PDT) With Metvix® 160 mg/g Cream in Comparison to PDT With Placebo Cream in Patients With Primary Nodular Basal Cell Carcinoma. [NCT00472043]Phase 366 participants (Actual)Interventional2000-10-31Completed
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 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
Comparison of Metvix PDT With Its Vehicle in the Treatment of Photoaged Skin [NCT00437320]Phase 245 participants (Anticipated)Interventional2007-03-31Completed
Laser-Mediated Photodynamic Therapy of Acne Vulgaris and Rosacea [NCT00483145]0 participants Interventional2006-11-30Completed
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
Safety and Efficacy of Photodynamic Therapy With Short Incubation Methylaminolevulinate Without Occlusion in the Treatment of Actinic Keratoses. [NCT00926952]Phase 320 participants (Actual)Interventional2009-07-31Completed
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 [NCT00304239]Phase 3131 participants (Actual)Interventional2006-03-13Completed
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
[NCT00594425]Phase 2150 participants (Actual)Interventional2007-02-28Completed
Multi-centre, Randomized, Investigator-blind, Intra-individual Active and Vehicle-controlled Study, Comparing Metvix Natural Daylight Photodynamic Therapy Versus Metvix Conventional Photodynamic Therapy in Subjects With Actinic Keratosis [NCT01821391]Phase 3131 participants (Actual)Interventional2013-07-31Completed
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
Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses [NCT02373371]Phase 326 participants (Actual)Interventional2015-03-25Completed
Histological and Immunohistochemical Study of Photodamaged Skin Submitted to MAL-PDT [NCT00843323]26 participants (Actual)Interventional2008-12-31Completed
A Randomized Controlled Trial of a Full and a Fractional Ablative Carbon Dioxide Laser as Pretreatment for Photodynamic Therapy in the Management of Superficial Non Melanoma Skin Cancer [NCT03012009]16 participants (Actual)Interventional2014-09-30Completed
"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
Evaluation of the Ability of PpIX Fluorescence to Mark High-grade Vulvar Intraepithelial Neoplasia Following the Methyl Aminolevulinate (Metvixia®) Application [NCT05104099]Phase 217 participants (Anticipated)Interventional2021-11-29Recruiting
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
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
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
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
Exploratory Study to Compare Mechanical Penetration Enhancers on Metvixia Skin Penetration [NCT02511145]Phase 110 participants (Actual)Interventional2014-02-28Completed
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
NCT00304239 (3) [back to overview]Participant Complete Response Rate (CRR)
NCT00304239 (3) [back to overview]Number of Participants With at Least One Treatment Site Adverse Events
NCT00304239 (3) [back to overview]Lesion Complete Response Rate
NCT00473343 (6) [back to overview]Recurrence Rate in Complete Clearance Group
NCT00473343 (6) [back to overview]Overall Cosmetic Outcome Assessed by Participants 3 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 Investigator 24, 36, 48, and 60 Months After the 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]Number of Lesion With Complete Response 3 Months After Last Metvix PDT Cycle
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 Erythema 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 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 Erythema After First 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 Second 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 Hyperpigmentation After First 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 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]Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts
NCT00594425 (34) [back to overview]Change in Facial Inflammatory (Nodules, Papules, and Pustules) Lesion Counts From Baseline
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]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]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]Median Percentage Change in Facial Non Inflammatory Lesion Counts From Baseline
NCT00594425 (34) [back to overview]Percent Reduction in Total Lesion Counts From Baseline
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 Severe Erythema 2 Days 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 After Fourth Treatment
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 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]Proportion of Patients With Severe Erythema After First Treatment
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 First PDT
NCT00673933 (6) [back to overview]Erythema Score (Mild and Moderate)1 Day After First Treatment
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)Immediately After Second Treatment
NCT00926952 (9) [back to overview]Mean Coarse Wrinkling Score at Week 12
NCT00926952 (9) [back to overview]Mean Fine Wrinkling Score at Week 12
NCT00926952 (9) [back to overview]Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12
NCT00926952 (9) [back to overview]Mean Mottled Hyperpigmentation at Week 12
NCT00926952 (9) [back to overview]Mean Number of Facial Actinic Keratoses at Week 12
NCT00926952 (9) [back to overview]Mean Sallowness Score at Week 12
NCT00926952 (9) [back to overview]Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12
NCT00926952 (9) [back to overview]Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12
NCT00926952 (9) [back to overview]Number of Adverse Events
NCT01000636 (2) [back to overview]Percent Change From Baseline in Lesion Count at Week 18
NCT01000636 (2) [back to overview]Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15
NCT01475071 (2) [back to overview]Lesion Response
NCT01475071 (2) [back to overview]Pain Score
NCT01821391 (1) [back to overview]Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1
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]Adverse Reactions
NCT02149342 (4) [back to overview]Clinical Lesion Clearance
NCT02149342 (4) [back to overview]Histological Lesion Clearance
NCT02149342 (4) [back to overview]Pain Assesment (Visual Analog Scale)
NCT02373371 (4) [back to overview]Lesions Disappearance Rate at 6 Months From Baseline.
NCT02373371 (4) [back to overview]Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12
NCT02373371 (4) [back to overview]Lesions Disappearance Rate at 1 Months From Baseline.
NCT02373371 (4) [back to overview]Pain Assesment
NCT03511326 (2) [back to overview]Overall Subject Satisfaction the Day of Treatment After Daylight Session
NCT03511326 (2) [back to overview]Overall Subject Satisfaction at Week 12 Post-treatment

Participant Complete Response Rate (CRR)

Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator. (NCT00304239)
Timeframe: At Week 13

InterventionPercentage of participants (Number)
Metvix-PDT68.4
Vehicle-PDT6.9

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Number of Participants With at Least One Treatment Site Adverse Events

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. Number of participants with at least one treatment site adverse events were reported. (NCT00304239)
Timeframe: From start of study drug administration up to Week 13

InterventionParticipants (Count of Participants)
Metvix-PDT61
Vehicle-PDT27

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Lesion Complete Response Rate

Lesion complete response rate was defined as the percentage of pre-existing and treated lesions at baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) after treatment. Percentage of lesions reported by location. (NCT00304239)
Timeframe: At Week 13

,
InterventionPercentage of lesions (Number)
FaceScalp
Metvix-PDT8981
Vehicle-PDT2830

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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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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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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 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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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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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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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 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 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: 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 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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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 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 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 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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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 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 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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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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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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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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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 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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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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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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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 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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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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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: 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 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 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 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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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 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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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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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 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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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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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)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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Mean Coarse Wrinkling Score at Week 12

"This factor represents a visual assessment of the number and depth of coarse wrinkles (i.e. deep lines, furrows, or creases). Coarse wrinkles appear on the forehead, glabella, chin, and nasolabial and periorbital areas, and they tend to be located closer to the eyes and mouth than fine wrinkles.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe" (NCT00926952)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
MAL-PDT 90 Min Incubation, no Occlusion4.55

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Mean Fine Wrinkling Score at Week 12

"This factor represents a visual assessment of the number and depth of superficial wrinkles (i.e. shallow indentations or lines). Fine wrinkles typically appear in periorbital and perioral regions and are usually found further from the eyes and mouth than are coarse wrinkles.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe" (NCT00926952)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
MAL-PDT 90 Min Incubation, no Occlusion4.30

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Mean Griffiths Photonumeric Scale for Photodamage Score at Week 12

Griffiths photonumeric scale was evaluated by the dermatologist. Patients were placed under natural daylight or fluorescent lighting for grading. A direct comparison was then made between the subjects and photographic standards (provided in reference 1). If an exact match could not be made to a grade then an inter-grade number was used used, for example 1, 3, 5, or 7. Zero (0) is the least amount of photodamage, 8 is the most amount of photodamage. (NCT00926952)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
MAL-PDT 90 Min Incubation, no Occlusion4.85

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Mean Mottled Hyperpigmentation at Week 12

"This factor represents a visual assessment of light, patchy, mottled hyperpigmentation and solar freckling (including melasma) based on quantitative criteria such as the area/density of pigment, color intensity (dark vs. light), and uniformity of distribution (i.e. the more uneven or blotchy, the greater the score), Lentigines, nevi, and other pigmented lesions are not to be included in this assessment.~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe" (NCT00926952)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
MAL-PDT 90 Min Incubation, no Occlusion4.40

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Mean Number of Facial Actinic Keratoses at Week 12

(NCT00926952)
Timeframe: 12 weeks

InterventionLesions (Mean)
MAL-PDT 90 Min Incubation, no Occlusion2.70

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Mean Sallowness Score at Week 12

"This factor represents a visual assessment of color tone from very pink or rosy (0) to very sallow or pale (9).~Rating Category 0 None 1-3 Mild 4-6 Moderate 7-9 Severe" (NCT00926952)
Timeframe: 12 weeks

InterventionUnits on a scale (Mean)
MAL-PDT 90 Min Incubation, no Occlusion3.10

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Number of Patients With Complete Clinical Response of All Actinic Keratoses at Week 12

The proportion of patients with a complete clinical response is calculated by dividing the number of patients with a complete response at week 12 by the number of participants at baseline. (NCT00926952)
Timeframe: 12 weeks

InterventionParticipants (Number)
MAL-PDT 90 Min Incubation, no Occlusion3

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Number of Actinic Keratosis Lesions With Complete Clinical Response at Day 0 and Week 12

(NCT00926952)
Timeframe: 0, 12 weeks

InterventionLesions (Number)
Day 0 - Total lesions at baselineWeek 12 - Lesions with complete clinical response
MAL-PDT 90 Min Incubation, no Occlusion197143

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Number of Adverse Events

To study the safety of MAL-PDT performed without occlusion when red light exposure takes place 90 minutes after the application of MAL by tracking adverse events until week 12 and adverse events until week 24 (NCT00926952)
Timeframe: 12, 24 weeks

InterventionAdverse events (Number)
Week 12Week 24
MAL-PDT 90 Min Incubation, no Occlusion110

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Percent Change From Baseline in Lesion Count at Week 18

Percent Change in Lesion Counts at Week 18: Week 18 count minus Baseline count divided by Baseline count multiplied by 100. (NCT01000636)
Timeframe: Baseline and Week 18.

Interventionpercent change (Mean)
Metvix® Photodynamic Therapy (PDT)95.5

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Global Percent Change From Baseline in AK Lesion Count in the Target Field (Including New and Recurrent Lesions) at Month15

(NCT01000636)
Timeframe: Baseline and Month15

InterventionPercent change from baseline (Mean)
Metvix® Photodynamic Therapy (PDT)71

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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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Percentage (%) Change From Baseline in Total Lesion Complete Response at Week 12 in Group 1

The lesion complete response rate was defined as the percentage of pre-existing and treated lesions at Baseline that were assessed as clear (complete disappearance of the lesion, visually and by palpation) at Week 12. New lesions or the lesions in non-complete response were not not considered in the lesion response assessment. This outcome measure was analyzed as an intra-individual comparison between Metvix NDL-PDT on one side of the face/scalp and Metvix vehicle cream (placebo) c-PDT on the contralateral side (Group I). (NCT01821391)
Timeframe: Baseline, Week 12

Interventionpercentage change from baseline (Mean)
Group I: Metvix NDL-PDT68.4
Group I: Metvix c-PDT71.5

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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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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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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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Lesions Disappearance Rate at 6 Months From Baseline.

"The number of lesions is assessed at baseline (before treatment) and 6 month later.~The difference in lesions is recorded for each patient. The rate is the quotient: difference in lesions between baseline and at 6 month /nubmer of lesions at baseline" (NCT02373371)
Timeframe: 0(baseline), 6 month

Interventionpercentage of disappeared lesions (Mean)
Daylight90.9
Conventional Treatment94.7

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Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12

"The number of lesions is assessed at baseline (before treatment) and 12 weeks later.~The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients." (NCT02373371)
Timeframe: Baseline and Week 12

Interventionnumber of lesions (Mean)
Daylight19.6
Conventional Treatment20.0

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Lesions Disappearance Rate at 1 Months From Baseline.

"The number of lesions is assessed at baseline (before treatment) and 1 month later.~The difference in lesions is recorded for each patient. The rate is the quotient: difference in lesions between baseline and at 1 month /nubmer of lesions at baseline" (NCT02373371)
Timeframe: 0(baseline),1 month

Interventionpercentage of disappeared lesions (Mean)
Daylight89.6
Conventional Treatment94.6

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Pain Assesment

"Pain assesment with a VAS Pain scale~Visual analog scale [VAS] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 10)." (NCT02373371)
Timeframe: at inclusion (after treatment)

Interventionunits on a scale (Mean)
Daylight1.2
Conventional Treatment5.1

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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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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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