Page last updated: 2024-12-04

azelaic acid

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Description

nonanedioic acid : An alpha,omega-dicarboxylic acid that is heptane substituted at positions 1 and 7 by carboxy groups. [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 CID2266
CHEMBL ID1238
CHEBI ID48131
SCHEMBL ID3887
MeSH IDM0055275

Synonyms (192)

Synonym
azelaic
BIDD:GT0315
MLS001148615
MLS000069659 ,
smr000059164
KBIO1_000532
DIVK1C_000532
SDCCGMLS-0066619.P001
LMFA01170054
agn-191861
zk-62498
skinorem
finevin
skinoren
sh-441
EU-0100051
finacea (tn)
azelex (tn)
D03034
azelaic acid (usan/inn)
azelaic acid, 98%
ai3-06299
SPECTRUM_000057
azelex
acide azelaique [french]
acido azelaico [spanish]
einecs 204-669-1
nsc 19493
brn 1101094
finacea
azelaic acid [usan:inn]
zk 62498
acidum azelaicum [latin]
BSPBIO_001756
emerox 1110
nsc19493
lepargylic acid
nsc-19493
emerox 1144
anchoic acid
1,9-nonanedioic acid
heptanedicarboxylic acid
azelaic acid, technical grade
lopac-246379
NCGC00014993-01
LOPAC0_000051
IDI1_000532
C08261
123-99-9
nonanedioic acid
AZELAIC ACID ,
1,7-heptanedicarboxylic acid
azelaic acid, technical grade, 80%
DB00548
1TUF
1,7-dicarboxyheptane
n-nonanedioic acid
NCGC00093565-06
NCGC00093565-03
NCGC00093565-02
NCGC00093565-04
KBIO3_001256
KBIO2_003005
KBIO2_005573
KBIO2_000437
KBIOGR_000662
KBIOSS_000437
SPECTRUM3_000278
SPECTRUM4_000401
SPBIO_001089
NINDS_000532
SPECTRUM2_000995
SPECTRUM1500648
SPECTRUM5_001304
NCGC00093565-01
NCGC00093565-05
NCGC00093565-07
CHEBI:48131 ,
inchi=1/c9h16o4/c10-8(11)6-4-2-1-3-5-7-9(12)13/h1-7h2,(h,10,11)(h,12,13
A-9800 ,
azelate
NCGC00014993-02
dicarboxylic acid c9; nonanedioic acid; aza
0C50D8EC-0DB0-4F24-8EFC-2919E1F0D9BF
HMS2092E22
A0561
NCGC00014993-09
CHEMBL1238
HMS501K14
STL059432
HMS1921O11
NCGC00014993-07
AKOS000120052
HMS3260K03
cas-123-99-9
dtxsid8021640 ,
dtxcid501640
tox21_303011
NCGC00256508-01
NCGC00259538-01
tox21_201989
nsc-757406
nsc757406
pharmakon1600-01500648
tox21_110063
26776-28-3
HMS2234D10
S4550
CCG-40081
NCGC00014993-08
NCGC00014993-10
NCGC00014993-04
NCGC00014993-03
NCGC00014993-05
NCGC00014993-06
azalaic acid
emery's l-110
azelainic acid
acidum azelaicum
4-02-00-02055 (beilstein handbook reference)
f2vw3d43yt ,
acido azelaico
ec 204-669-1
hsdb 7659
acide azelaique
unii-f2vw3d43yt
FT-0626920
LP00051
azelainsaeure
nonandisaeure
EPITOPE ID:187039
HMS3372J07
azelaic acid [who-dd]
azelaic acid [mart.]
azelaic acid [hsdb]
azelaic acid [mi]
azelaic acid [inn]
azelaic acid [inci]
azelaic acid [orange book]
azelaic acid [usan]
azelaic acid [vandf]
heptane-1,7-dicarboxylic acid
SCHEMBL3887
NCGC00014993-12
tox21_110063_1
gtpl7484
KS-5293
NCGC00260736-01
tox21_500051
HY-B0704
MLS-0066619.P021
OPERA_ID_740
AB00052140_12
F8889-5093
mfcd00004432
azelaic acid, analytical standard
SR-01000075671-1
sr-01000075671
azelaic acid, technical, ~85% (gc)
MLS-0066619
azelaic acid, vetec(tm) reagent grade
SR-01000075671-4
SR-01000075671-6
SBI-0050040.P003
anchoate
n-nonanedioate
azelaicacidtech
lepargylate
1,9-nonanedioate
1,7-heptanedicarboxylate
nonanedioic acid azelaic acid
Z57127532
BCP18690
water-soluble azelaic acid
Q413504
SDCCGSBI-0050040.P004
NCGC00014993-15
azelaic-acid
D70171
SDCCGMLS-0066619.P033
EN300-18040
BP-27863
water-solubleazelaicacid
azelaic acid, 99%
acidum azelaicum (latin)
d10ax03
nonandisaure
finacea foam
azelaic acid gel
azelaic acid (mart.)
acidum acelaicum
azelainsaure

Research Excerpts

Overview

Azelaic acid (AzA) is a dicarboxylic acid that has been shown to play a role in plant-bacteria signalling and also occurs naturally in several cereals. Azelaic Acid (AZA) possesses antibacterial and keratolytic activity.

ExcerptReferenceRelevance
"Azelaic acid (AzA) is a USFDA bioactive prescribed against acne vulgaris. "( Hydrogel composite containing azelaic acid and tea tree essential oil as a therapeutic strategy for Propionibacterium and testosterone-induced acne.
Aljabali, AAA; Bakshi, HA; Bisht, A; Chakraborty, A; Chellappan, DK; Dev, K; Dhiman, T; Dua, K; Gupta, G; Hemrajani, C; Negi, P; Nidhi, P; Rathore, C; Rolta, R; Sourirajan, A; Tambuwala, MM; Upadhyay, N, 2022
)
2.45
"Azelaic Acid (AzA) is a 9-carbon atom dicarboxylic acid, with numerous pharmacological uses in dermatology. "( Extraction and Quantification of Azelaic Acid from Different Wheat Samples (
Annunziato, G; Cabassi, CS; Costantino, G; Iannarelli, M; Montanaro, SL; Spadini, C; Spaggiari, C, 2023
)
2.63
"Azelaic acid is a dicarboxylic acid that has recently been shown to play a role in plant-bacteria signalling and also occurs naturally in several cereals. "( AzeR, a transcriptional regulator that responds to azelaic acid in
Bertani, I; Bez, C; Devescovi, G; Geller, AM; Guarnaccia, C; Javvadi, SG; Levy, A; Studholme, DJ; Venturi, V, 2020
)
2.25
"Azelaic acid (AzA) is a dicarboxylic acid naturally occurring in various grains having anti-inflammatory and anti-oxidation properties. "( Azelaic Acid Promotes Caenorhabditis elegans Longevity at Low Temperature Via an Increase in Fatty Acid Desaturation.
Ahn, JB; Bai, J; Farias-Pereira, R; Jang, M; Kim, GH; Kim, KH; Kim, YS; Lee, SM; Park, Y; Zhang, Y, 2021
)
3.51
"Azelaic acid (AZA) is a white crystalline dicarboxylic acid naturally found in grains, rye, and barley. "( Cosmeceutical Aptitudes of Azelaic Acid.
Bansal, A; Chaubey, S; Kaur, G; Malik, DS; Singh, SK, 2021
)
2.36
"Azelaic acid, which is a nine-carbon (C9) saturated dicarboxylic acid, has been reported in plants as a mobile signal that primes systemic defenses."( The spent culture supernatant of Pseudomonas syringae contains azelaic acid.
Cescutti, P; Guarnaccia, C; Javvadi, SG; Licastro, D; Lonzarich, V; Navarini, L; Rizzo, R; Venturi, V, 2018
)
1.44
"Azelaic acid (AZA) is a dicarboxylic acid that is topically used in the treatment of acne and rosacea since it possesses antibacterial and keratolytic activity. "( Preparation of in situ hydrogels loaded with azelaic acid nanocrystals and their dermal application performance study.
Cetina Čižmek, B; Filipović-Grčić, J; Jug, M; Juretić, M; Pepić, I; Tomić, I, 2019
)
2.22
"Azelaic acid is a complex molecule with many diverse activities. "( Azelaic Acid: Evidence-based Update on Mechanism of Action and Clinical Application.
Rosen, T; Schulte, BC; Wu, W, 2015
)
3.3
"Azelaic acid is a dicarboxylic acid compound used in treatment of acne vulgaris. "( A prodrug approach to enhance azelaic acid percutaneous availability.
Al-Bakri, AG; Al-Marabeh, S; Alzweiri, M; Khalil, E; Khanfar, M, 2017
)
2.19
"Azelaic acid is a naturally occurring saturated C9-dicarboxylic acid which has been shown to be effective in the treatment of comedonal acne and inflammatory acne, as well as hiperpigmentary skin disorders. "( New effective azelaic acid liposomal gel formulation of enhanced pharmaceutical bioavailability.
Burchacka, E; Han, S; Han, T; Karłowicz-Bodalska, K; Paduszyński, P; Potaczek, P, 2016
)
2.24
"Azelaic acid (AZ) is a saturated dicarboxylic acid found naturally in wheat, rye, and barley."( Effect of combination of taurine and azelaic acid on antimelanogenesis in murine melanoma cells.
Kim, AK; Yu, JS, 2010
)
1.35
"Azelaic acid is a naturally occurring, straight-chain dicarboxylic acid which is effective in the treatment of rosacea, presumably on account of its anti-inflammatory properties. "( Azelaic acid 15% gel: in the treatment of papulopustular rosacea.
Frampton, JE; Wagstaff, AJ, 2004
)
3.21
"Azelaic acid gel is an effective topical monotherapy for mild-to-moderate acne vulgaris; its new gel form is an enrichment of acne therapy."( [Azelaic acid 15% gel in the treatment of acne vulgaris. Combined results of two double-blind clinical comparative studies].
Gollnick, HP; Graupe, K; Zaumseil, RP, 2004
)
2.68
"Azelaic acid (AzA) is a naturally occurring dicarboxylic acid that has a long and complex history in the treatment of skin disorders. "( The evolution of azelaic acid.
Fleischer, AB, 2006
)
2.12
"Azelaic acid is a saturated dicarboxylic acid, which is naturally occurring and has been used in the treatment of rosacea, acne, and melasma."( Azelaic acid (15% gel) in the treatment of acne rosacea.
Gover, MD; Gupta, AK, 2007
)
2.5
"Azelaic acid (AzAc) is a C9 dicarboxylic acid which has recently been shown to have some therapeutic applications in skin diseases of different aetiologies. "( Karyotype modifications in human malignant melanoma cell cultures after treatment with azelaic acid.
Del Porto, G; Grammatico, P; Nazzaro-Porro, M; Picardo, M; Scarpa, S; Steindl, K, 1993
)
1.95
"Azelaic acid is a therapeutic agent with well-known antibacterial properties, but its antimycotic effect has not yet been investigated systematically. "( Azelaic acid has antimycotic properties in vitro.
Brasch, J; Christophers, E, 1993
)
3.17
"Thus azelaic acid is an effective and well-tolerated treatment for hyperpigmentation in darker-skinned patients."( Azelaic acid 20% cream in the treatment of facial hyperpigmentation in darker-skinned patients.
Billips, M; Grimes, P; Lowe, NJ; Pincus, S; Rizk, D,
)
2.03
"Azelaic acid is a naturally occurring straight-chained 9-carbon atom dicarboxylic acid which is non-toxic, non-teratogenic, and non-mutagenic. "( Azelaic acid: potential as a general antitumoural agent.
Breathnach, AS, 1999
)
3.19
"Azelaic acid is an aliphatic dicarboxylic acid (HOOC-(CH2)7-COOH) which has recently been shown to have some practical therapeutic applications in skin diseases of different etiologies. "( Scavenging activity of azelaic acid on hydroxyl radicals "in vitro".
Breathnach, AS; De Luca, C; Nazzaro-Porro, M; Passi, S; Picardo, M, 1991
)
2.03
"Azelaic acid is a naturally occurring saturated dicarboxylic acid which, on topical application (usually as a 20% cream), has been shown to be effective in the treatment of comedonal acne and inflammatory (papulopustular, nodular and nodulocystic) acne, as well as various cutaneous hyperpigmentary disorders characterised by hyperactive/abnormal melanocyte function, including melasma and, possibly, lentigo maligna. "( Azelaic acid. A review of its pharmacological properties and therapeutic efficacy in acne and hyperpigmentary skin disorders.
Fitton, A; Goa, KL, 1991
)
3.17
"Azelaic acid is a competitive inhibitor of mitochondrial oxidoreductases and of 5 alpha-reductase, inhibiting the conversion of testosterone to 5-dehydrotestosterone."( [Mechanism of azelaic acid action in acne].
De Luca, C; Nazzaro-Porro, M; Passi, S; Picardo, M, 1989
)
1.36

Effects

Azelaic acid (AzA) 15% gel has been available in the United States for slightly over a decade, approved for treatment of the inflammatory lesions (papules and pustules) of rosacea. Azelaic Acid has strong antibacterial potency without inducing bacterial resistance similar to benzoyl peroxide.

ExcerptReferenceRelevance
"Azelaic acid has a predominant antibacterial action, although it is not considered as an antibiotic in the classical sense."( [Acne therapy with topical benzoyl peroxide, antibiotics and azelaic acid].
Fluhr, JW; Worret, WI, 2006
)
1.3
"Azelaic acid has numerous pharmacological uses in dermatology. "( The versatility of azelaic acid in dermatology.
Al-Niaimi, F; Ali, FR; Searle, T, 2022
)
2.49
"Azelaic acid cream has been previously approved for acne vulgaris, thus azelaic acid foam may be a viable treatment option for truncal acne.

STUDY DESIGN: A single-center, open label pilot study was conducted to investigate the efficacy and safety of azelaic acid 15% foam as a treatment modality for moderate truncal acne."

( The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Truncal Acne Vulgaris.
Del Rosso, JQ; Hoffman, LK; Kircik, LH, 2017
)
1.47
"Azelaic acid has been found to inhibit the pathologic expression of cathelicidin, as well as the hyperactive protease activity that cleaves cathelicidin into LL-37."( Real-World Efficacy of Azelaic Acid 15% Gel for the Reduction of Inflammatory Lesions of Rosacea.
Henderson Berg, MH; Sadick, N; Wirth, PJ, 2017
)
1.49
"Azelaic acid (AzA) has profound anti-inflammatory, antioxidative effects, and is bactericidal against a range of Gram-negative and Gram-positive microorganisms as well, including antibiotic-resistant bacterial strains."( Azelaic acid: Properties and mode of action.
Hegel, JK; Sieber, MA, 2014
)
2.57
"Azelaic acid (AzA) 15% gel has been available in the United States for slightly over a decade, approved for treatment of the inflammatory lesions (papules and pustules) of rosacea. "( Update on the management of rosacea: a status report on the current role and new horizons with topical azelaic acid.
Del Rosso, JQ; Kircik, LH, 2014
)
2.06
"Azelaic acid per se has multiple modes of action in rosacea, but an anti-inflammatory effect achieved by reducing reactive oxygen species appears to be the main pharmacological action."( Azelaic acid 15% gel in the treatment of rosacea.
Gollnick, H; Layton, A, 2008
)
2.51
"Azelaic acid has been identified as a pathogen-induced metabolite in Arabidopsis vascular sap that has several properties of a long-distance resistance-priming signal."( The quest for long-distance signals in plant systemic immunity.
Parker, JE, 2009
)
1.07
"Azelaic acid has recently been reported to act as a mobile "priming" agent to arm plants against pathogenic attack."( Cellulase applied to the leaves of sweet pepper (Capsicum annuum L. var. grossum) upregulates the production of salicylic and azelaic acids.
Matsuura, H; Nabeta, K; Oka, N; Sato, C, 2011
)
1.3
"Azelaic acid (AzA) has been used for the treatment for inflammatory skin diseases, such as acne and rosacea. "( Azelaic acid reduced senescence-like phenotype in photo-irradiated human dermal fibroblasts: possible implication of PPARγ.
Briganti, S; Camera, E; Cardinali, G; Flori, E; Kovacs, D; Ludovici, M; Mastrofrancesco, A; Picardo, M, 2013
)
3.28
"Azelaic acid has a predominant antibacterial action, although it is not considered as an antibiotic in the classical sense."( [Acne therapy with topical benzoyl peroxide, antibiotics and azelaic acid].
Fluhr, JW; Worret, WI, 2006
)
1.3
"Azelaic acid (AZA) has been used successfully in the treatment of lentigo maligna melanoma. "( Azelaic acid decreases the fibrinolytic potential of cultured human melanoma cells in vitro.
Addo-Boadu, K; Binder, BR; Christ, G; Hufnagl, P; Pehamberger, H; Wojta, J, 1996
)
3.18
"Azelaic acid also has significant antimicrobial activity relevant to its efficacy in acne vulgaris."( Rationale for the development of new topical treatments for acne vulgaris.
Gibson, JR, 1996
)
1.02
"Azelaic acid has strong antibacterial potency without inducing bacterial resistance similar to benzoyl peroxide."( Topical drug treatment in acne.
Gollnick, H; Schramm, M, 1998
)
1.02
"Azelaic acid has been used to treat different hyperpigmentary disorders because of its antimelanocyte activity. "( Recurrent lentigo maligna melanoma: regression associated with local azelaic acid 20%.
Heenen, M; Vereecken, P,
)
1.81
"Azelaic acid (AZA) has been reported to have an inhibitory effect on DNA synthesis of melanoma cell lines. "( Azelaic acid: mode of action at cellular and subcellular levels.
Galhaup, I, 1989
)
3.16
"Azelaic acid has been shown to have a dose- and time-dependent inhibitory effect on both proliferation and cell viability of murine and human melanoma cells at a concentration of 10(-3) M and higher. "( Hyperpigmentary disorders--mechanisms of action. Effect of azelaic acid on melanoma and other tumoral cells in culture.
Breathnach, AS; Nazzaro-Porro, M; Passi, S; Picardo, M; Robins, EJ, 1989
)
1.96
"Azelaic acid has been shown to inhibit thioredoxin reductase (TR) at the surface of guinea pig and human skin, on cultures of human keratinocytes, melanocytes, melanoma cells, murine melanoma cells (Cloudman S91), and on purified enzymes from Escherichia coli, rat liver, and human melanoma. "( Azelaic acid as a competitive inhibitor of thioredoxin reductase in human melanoma cells.
Schallreuter, KU; Wood, JM, 1987
)
3.16
"Azelaic acid has been shown clinically to have a cytotoxic effect on the abnormally active and malignant human melanocyte, but it has no apparent effect upon normal melanocytes. "( Ultrastructural observations on the effect of azelaic acid on normal human melanocytes and a human melanoma cell line in tissue culture.
Bennett, D; Bhasin, Y; Breathnach, AS; Ethridge, L; Nazzaro-Porro, M; Passi, S; Picardo, M; Robins, EJ; Ward, BJ, 1985
)
1.97

Treatment

Treatment with azelaic acid 20% cream significantly improves acne severity and disease-related QoL in adult women. In terms of treatment response (PGA), azelaIC acid is probably less effective than benzoyl peroxide (risk ratio (RR) 0.82, 95% confidence interval (CI)0.72 to 0.95)

ExcerptReferenceRelevance
"Azelaic acid In terms of treatment response (PGA), azelaic acid is probably less effective than benzoyl peroxide (risk ratio (RR) 0.82, 95% confidence interval (CI) 0.72 to 0.95; 1 study, 351 participants), but there is probably little or no difference when comparing azelaic acid to tretinoin (RR 0.94, 95% CI 0.78 to 1.14; 1 study, 289 participants) (both moderate-quality evidence)."( Topical azelaic acid, salicylic acid, nicotinamide, sulphur, zinc and fruit acid (alpha-hydroxy acid) for acne.
Liu, GJ; Liu, H; Liu, L; Peinemann, F; Sang, H; Xia, J; Yu, H, 2020
)
1.71
"Azelaic acid cream treatment also resulted in significantly more favourable overall improvements than vehicle in both physician (p = 0.020) and patient ratings (p = 0.042)."( Double-blind comparison of azelaic acid 20% cream and its vehicle in treatment of papulo-pustular rosacea.
Bjerke, R; Fyrand, O; Graupe, K, 1999
)
1.32
"with azelaic acid treatment was 224 and 30-fold, respectively."( Topical azelaic acid and the treatment of acne: a clinical and laboratory comparison with oral tetracycline.
Bladon, PT; Burke, BM; Cunliffe, WJ; Forster, RA; Holland, KT; King, K, 1986
)
1.16
"Treatment with azelaic acid 20 % cream significantly improves acne severity and disease-related QoL in adult women."( Azelaic acid 20 % cream: effects on quality of life and disease severity in adult female acne patients.
Auer-Grumbach, P; Berghammer, G; Kainz, JT; Lackner, V; Perl-Convalexius, S; Popa, R; Wolfesberger, B, 2016
)
2.23

Toxicity

Azelaic acid 15% foam was well tolerated. Almost all instances of erythema, dryness, peeling, oiliness, pruritus, and burning were mild or trace degree. Most adverse effects resolving by the end of the study.

ExcerptReferenceRelevance
" Particular advantages of AzA therapy include its favorable safety and side effect profile."( Efficacy and safety of topical azelaic acid (20 percent cream): an overview of results from European clinical trials and experimental reports.
Cunliffe, WJ; Gollnick, HP; Graupe, K; Zaumseil, RP, 1996
)
0.58
"Rosacea is a common, chronic dermatosis for which safe and effective new treatment options are needed."( Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: results from two vehicle-controlled, randomized phase III studies.
Graupe, K; Thiboutot, D; Thieroff-Ekerdt, R, 2003
)
0.63
" No serious, treatment-related adverse events were reported."( Efficacy and safety of azelaic acid (15%) gel as a new treatment for papulopustular rosacea: results from two vehicle-controlled, randomized phase III studies.
Graupe, K; Thiboutot, D; Thieroff-Ekerdt, R, 2003
)
0.63
"5 million adverse drug reaction (ADR) reports for 8620 drugs/biologics that are listed for 1191 Coding Symbols for Thesaurus of Adverse Reaction (COSTAR) terms of adverse effects."( Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
Benz, RD; Contrera, JF; Kruhlak, NL; Matthews, EJ; Weaver, JL, 2004
)
0.32
" Therefore, the present study suggests that combined treatment with serial glycolic acid peels, azelaic acid cream and adapalene gel should be considered as an effective and safe therapy in recalcitrant melasma."( Efficacy and safety of serial glycolic acid peels and a topical regimen in the treatment of recalcitrant melasma.
Arca, E; Erbil, H; Kurumlu, Z; Sezer, E; Taştan, B, 2007
)
0.56
" AA and its derivatives were safe for topical use when entrapped in nanovesicles because of no toxicity to normal cell lines and no allergy on rabbit skin."( Safety assessment of azelaic acid and its derivatives entrapped in nanovesicles.
Manosroi, A; Manosroi, J; Panyosak, A; Rojanasakul, Y, 2009
)
0.67
" Only 7% of participants had treatment-related adverse events (AEs), mostly mild or moderate in severity."( Effectiveness and safety of doxycycline 40 mg (30-mg immediate-release and 10-mg delayed-release beads) once daily as add-on therapy to existing topical regimens for the treatment of papulopustular rosacea: results from a community-based trial.
Del Rosso, JQ, 2010
)
0.36
"Growing numbers of post-adolescent females are suffering from treatment-resistant or relapsing adult acne forms, therefore requiring the definition of safe and effective treatment options for this burdening disease."( A randomized investigator-blind parallel-group study to assess efficacy and safety of azelaic acid 15% gel vs. adapalene 0.1% gel in the treatment and maintenance treatment of female adult acne.
Gollnick, H; Kropf, S; Lux, A; Papakonstantinou, E; Thielitz, A; Wiede, A, 2015
)
0.64
" Two phase 3 trials have demonstrated that IVM 1% cream was significantly better than vehicle at investigator global assessment (IGA) success rate and lesion reductions and that it was safe and well tolerated."( Long-term safety of ivermectin 1% cream vs azelaic acid 15% gel in treating inflammatory lesions of rosacea: results of two 40-week controlled, investigator-blinded trials.
Appell, M; Draelos, Z; Fleischer, A; Fowler, J; Jackson, JM; Jacovella, J; Kircik, L; Liu, H; Lynde, C; Stein Gold, L; Steinhoff, M; Sugarman, J; Tan, J, 2014
)
0.67
" Azelaic acid 15% foam was well tolerated, with almost all instances of erythema, dryness, peeling, oiliness, pruritus, and burning being of mild or trace degree, and most adverse effects resolving by the end of the study."( The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Facial Acne Vulgaris.
Chen, T; Harper, JC; Hashim, PW; Kircik, LH, 2018
)
1.69
"Azelaic acid 15% foam is effective and safe in the treatment of facial acne vulgaris."( The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Facial Acne Vulgaris.
Chen, T; Harper, JC; Hashim, PW; Kircik, LH, 2018
)
2.22
" Original studies that reported pre- and post-treatment Melasma Area Severity Index (MASI)/modified Melasma Area Severity Index (mMASI) scores and/or adverse effects (AEs) were eligible for inclusion."( Efficacy and safety of topical agents in the treatment of melasma: What's evidence? A systematic review and meta-analysis.
Aljabban, A; Bain, PA; Bay, CP; Chang, YF; Chung, HJ; Desai, SR; Lee, TL; Oyerinde, O, 2023
)
0.91

Compound-Compound Interactions

ExcerptReferenceRelevance
" Rosacea is most commonly managed with topical metronidazole, sometimes in combination with oral antibiotics."( Managing rosacea: a review of the use of metronidazole alone and in combination with oral antibiotics.
Balkrishnan, R; Conde, JF; Feldman, SR; Fleischer, AB; Yelverton, CB, 2007
)
0.34
"75% lotion is more effective when used in combination with doxycycline 20 mg dosed twice daily."( Managing rosacea: a review of the use of metronidazole alone and in combination with oral antibiotics.
Balkrishnan, R; Conde, JF; Feldman, SR; Fleischer, AB; Yelverton, CB, 2007
)
0.34
" The aim of our study was to evaluate the efficacy of a new treatment protocol for acne based on an oral supplement composed of biotin and 3 strains of lactic ferments combined with a topical gel composed of azelaic acid, hydroxypinacolone retinoate, and α-hydroxy acids."( Probiotic supplement combined with topical therapy in the treatment of mild to moderate acne: results from an Italian single centre interventional study.
Annunziata, MC; Cacciapuoti, S; Fabbrocini, G; Marasca, C; Ruggiero, A, 2022
)
0.91
" Patients were treated with a supplement based on biotin and 3 strains of lactic ferments, combined with a topical gel product (azelaic-acid, hydroxypinacolone retinoate, and α-hydroxy acids)."( Probiotic supplement combined with topical therapy in the treatment of mild to moderate acne: results from an Italian single centre interventional study.
Annunziata, MC; Cacciapuoti, S; Fabbrocini, G; Marasca, C; Ruggiero, A, 2022
)
0.72

Bioavailability

ExcerptReferenceRelevance
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51

Dosage Studied

Once-daily AzA may be equally effective, with greater convenience and dosing flexibility. The aim of this study was to identify impurities observed during stability tests of a new liposomal dosage form of azelaic acid.

ExcerptRelevanceReference
" Excretion was also independent of dosage in rats."( Metabolism of straight saturated medium chain length (C9 to C12) dicarboxylic acids.
Fasella, P; Mingrone, G; Nazzaro-Porro, M; Passi, S; Picardo, M, 1983
)
0.27
" Two randomized, multicenter, controlled clinical trials compared the effects of AzA 15% gel with those of topical benzoyl peroxide 5% or topical clindamycin 1%, all using a twice-daily dosing regimen."( Versatility of azelaic acid 15% gel in treatment of inflammatory acne vulgaris.
Thiboutot, D, 2008
)
0.7
"Twice-daily azelaic acid (AzA) is the conventional regimen for papulopustular rosacea, but once-daily AzA may be equally effective, with greater convenience and dosing flexibility."( Azelaic acid 15% gel once daily versus twice daily in papulopustular rosacea.
Del Rosso, JQ; Fleischer, AB; Graupe, K; Thiboutot, DM, 2008
)
2.17
"Based on these findings and those of prior studies, once-daily AzA 15% gel can therefore be utilized as a safe, effective, and economical dosing option for the treatment of mild-to-moderate papulopustular rosacea."( Azelaic acid 15% gel once daily versus twice daily in papulopustular rosacea.
Del Rosso, JQ; Fleischer, AB; Graupe, K; Thiboutot, DM, 2008
)
1.79
" Further interesting therapy options for the short- and long-term therapy of rosacea could be low-dose minocycline and isotretinoin; however, too little data are available with regard to the effectiveness, safety, optimal dosage and appropriate length of treatment for these medications to draw final conclusions."( Current topical and systemic approaches to treatment of rosacea.
Korting, HC; Schöllmann, C, 2009
)
0.35
" At present, subantimicrobial dosing of a tetracycline agent that also maintains anti-inflammatory activity has only been established with doxycycline."( Optimal management of papulopustular rosacea: rationale for combination therapy.
Bhatia, ND; Del Rosso, JQ, 2012
)
0.38
" The aim of this study was to identify impurities observed during the stability tests of a new liposomal dosage form of azelaic acid that is composed of phosphatidylcholine and a mixture of ethyl alcohol and water, using high-performance liquid chromatography with evaporative light-scattering detector (HPLC-ELSD), gas chromatography-flame ionisation detection (GC-FID), and gas chromatography-mass spectrometry (GC-MS) methods."( Identification of unknown impurity of azelaic acid in liposomal formulation assessed by HPLC-ELSD, GC-FID, and GC-MS.
Han, S; Karłowicz-Bodalska, K; Musiał, W; Ozimek, L; Potaczek, P; Szura, D; Wójcik, A, 2014
)
0.88
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
antibacterial agentA substance (or active part thereof) that kills or slows the growth of bacteria.
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.
plant metaboliteAny eukaryotic metabolite produced during a metabolic reaction in plants, the kingdom that include flowering plants, conifers and other gymnosperms.
[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 (2)

ClassDescription
alpha,omega-dicarboxylic acid
dicarboxylic fatty 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]

Protein Targets (22)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Chain A, MAJOR APURINIC/APYRIMIDINIC ENDONUCLEASEHomo sapiens (human)Potency0.01410.003245.467312,589.2998AID2517
Chain A, Ferritin light chainEquus caballus (horse)Potency0.31625.623417.292931.6228AID485281
phosphopantetheinyl transferaseBacillus subtilisPotency3.16230.141337.9142100.0000AID1490
RAR-related orphan receptor gammaMus musculus (house mouse)Potency20.17530.006038.004119,952.5996AID1159521
NFKB1 protein, partialHomo sapiens (human)Potency0.00280.02827.055915.8489AID895; AID928
GLI family zinc finger 3Homo sapiens (human)Potency28.86460.000714.592883.7951AID1259369
thyroid stimulating hormone receptorHomo sapiens (human)Potency6.30960.001318.074339.8107AID926; AID938
estrogen receptor 2 (ER beta)Homo sapiens (human)Potency44.03850.000657.913322,387.1992AID1259377; AID1259394
cytochrome P450 family 3 subfamily A polypeptide 4Homo sapiens (human)Potency8.70900.01237.983543.2770AID1645841
estrogen-related nuclear receptor alphaHomo sapiens (human)Potency26.60320.001530.607315,848.9004AID1224820
estrogen nuclear receptor alphaHomo sapiens (human)Potency27.49450.000229.305416,493.5996AID743069; AID743075; AID743077; AID743079; AID743080
bromodomain adjacent to zinc finger domain 2BHomo sapiens (human)Potency0.63100.707936.904389.1251AID504333
arylsulfatase AHomo sapiens (human)Potency37.93301.069113.955137.9330AID720538
euchromatic histone-lysine N-methyltransferase 2Homo sapiens (human)Potency0.04740.035520.977089.1251AID504332
peripheral myelin protein 22 isoform 1Homo sapiens (human)Potency95.283423.934123.934123.9341AID1967
gemininHomo sapiens (human)Potency1.25890.004611.374133.4983AID624297
muscleblind-like protein 1 isoform 1Homo sapiens (human)Potency76.60260.00419.962528.1838AID2675; AID493199; AID493205
lamin isoform A-delta10Homo sapiens (human)Potency0.05250.891312.067628.1838AID1487
TAR DNA-binding protein 43Homo sapiens (human)Potency11.22021.778316.208135.4813AID652104
ATP-dependent phosphofructokinaseTrypanosoma brucei brucei TREU927Potency0.75690.060110.745337.9330AID485368
[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)
Chain A, Diaminopimelate decarboxylaseMethanocaldococcus jannaschiiKi89.000089.000089.000089.0000AID977610
Chain B, Diaminopimelate decarboxylaseMethanocaldococcus jannaschiiKi89.000089.000089.000089.0000AID977610
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (18)

Processvia Protein(s)Taxonomy
negative regulation of protein phosphorylationTAR DNA-binding protein 43Homo sapiens (human)
mRNA processingTAR DNA-binding protein 43Homo sapiens (human)
RNA splicingTAR DNA-binding protein 43Homo sapiens (human)
negative regulation of gene expressionTAR DNA-binding protein 43Homo sapiens (human)
regulation of protein stabilityTAR DNA-binding protein 43Homo sapiens (human)
positive regulation of insulin secretionTAR DNA-binding protein 43Homo sapiens (human)
response to endoplasmic reticulum stressTAR DNA-binding protein 43Homo sapiens (human)
positive regulation of protein import into nucleusTAR DNA-binding protein 43Homo sapiens (human)
regulation of circadian rhythmTAR DNA-binding protein 43Homo sapiens (human)
regulation of apoptotic processTAR DNA-binding protein 43Homo sapiens (human)
negative regulation by host of viral transcriptionTAR DNA-binding protein 43Homo sapiens (human)
rhythmic processTAR DNA-binding protein 43Homo sapiens (human)
regulation of cell cycleTAR DNA-binding protein 43Homo sapiens (human)
3'-UTR-mediated mRNA destabilizationTAR DNA-binding protein 43Homo sapiens (human)
3'-UTR-mediated mRNA stabilizationTAR DNA-binding protein 43Homo sapiens (human)
nuclear inner membrane organizationTAR DNA-binding protein 43Homo sapiens (human)
amyloid fibril formationTAR DNA-binding protein 43Homo sapiens (human)
regulation of gene expressionTAR DNA-binding protein 43Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (10)

Processvia Protein(s)Taxonomy
RNA polymerase II cis-regulatory region sequence-specific DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
double-stranded DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
RNA bindingTAR DNA-binding protein 43Homo sapiens (human)
mRNA 3'-UTR bindingTAR DNA-binding protein 43Homo sapiens (human)
protein bindingTAR DNA-binding protein 43Homo sapiens (human)
lipid bindingTAR DNA-binding protein 43Homo sapiens (human)
identical protein bindingTAR DNA-binding protein 43Homo sapiens (human)
pre-mRNA intronic bindingTAR DNA-binding protein 43Homo sapiens (human)
molecular condensate scaffold activityTAR DNA-binding protein 43Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (9)

Processvia Protein(s)Taxonomy
intracellular non-membrane-bounded organelleTAR DNA-binding protein 43Homo sapiens (human)
nucleusTAR DNA-binding protein 43Homo sapiens (human)
nucleoplasmTAR DNA-binding protein 43Homo sapiens (human)
perichromatin fibrilsTAR DNA-binding protein 43Homo sapiens (human)
mitochondrionTAR DNA-binding protein 43Homo sapiens (human)
cytoplasmic stress granuleTAR DNA-binding protein 43Homo sapiens (human)
nuclear speckTAR DNA-binding protein 43Homo sapiens (human)
interchromatin granuleTAR DNA-binding protein 43Homo sapiens (human)
nucleoplasmTAR DNA-binding protein 43Homo sapiens (human)
chromatinTAR DNA-binding protein 43Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (101)

Assay IDTitleYearJournalArticle
AID1347058CD47-SIRPalpha protein protein interaction - HTRF assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347405qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS LOPAC collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347050Natriuretic polypeptide receptor (hNpr2) antagonism - Pilot subtype selectivity assay2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID588378qHTS for Inhibitors of ATXN expression: Validation
AID1347049Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot screen2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
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.
AID1347057CD47-SIRPalpha protein protein interaction - LANCE assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347151Optimization of GU AMC qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID588349qHTS for Inhibitors of ATXN expression: Validation of Cytotoxic Assay
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347059CD47-SIRPalpha protein protein interaction - Alpha assay qHTS validation2019PloS one, , Volume: 14, Issue:7
Quantitative high-throughput screening assays for the discovery and development of SIRPα-CD47 interaction inhibitors.
AID1347410qHTS for inhibitors of adenylyl cyclases using a fission yeast platform: a pilot screen against the NCATS LOPAC library2019Cellular signalling, 08, Volume: 60A fission yeast platform for heterologous expression of mammalian adenylyl cyclases and high throughput screening.
AID1347045Natriuretic polypeptide receptor (hNpr1) antagonism - Pilot counterscreen GloSensor control cell line2019Science translational medicine, 07-10, Volume: 11, Issue:500
Inhibition of natriuretic peptide receptor 1 reduces itch in mice.
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.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID504836Inducers of the Endoplasmic Reticulum Stress Response (ERSR) in human glioma: Validation2002The Journal of biological chemistry, Apr-19, Volume: 277, Issue:16
Sustained ER Ca2+ depletion suppresses protein synthesis and induces activation-enhanced cell death in mast cells.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation 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.
AID588461High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation 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.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation 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.
AID588459High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation 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.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation 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.
AID588460High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation 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.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
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.
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.
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.
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.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
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).
AID588216FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
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).
AID588214FDA HLAED, liver enzyme composite activity2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588217FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID977599Inhibition of sodium fluorescein uptake in OATP1B1-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID588215FDA HLAED, alkaline phosphatase increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588218FDA HLAED, lactate dehydrogenase (LDH) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID521220Inhibition of neurosphere proliferation of mouse neural precursor cells by MTT assay2007Nature chemical biology, May, Volume: 3, Issue:5
Chemical genetics reveals a complex functional ground state of neural stem cells.
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).
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).
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).
AID588219FDA HLAED, gamma-glutamyl transferase (GGT) increase2004Current drug discovery technologies, Dec, Volume: 1, Issue:4
Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
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).
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).
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).
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).
AID977602Inhibition of sodium fluorescein uptake in OATP1B3-transfected CHO cells at an equimolar substrate-inhibitor concentration of 10 uM2013Molecular pharmacology, Jun, Volume: 83, Issue:6
Structure-based identification of OATP1B1/3 inhibitors.
AID43581Inhibition of beta-lactamase at 100 uM2003Journal of medicinal chemistry, Oct-09, Volume: 46, Issue:21
Identification and prediction of promiscuous aggregating inhibitors among known drugs.
AID106806Inhibition of malate dehydrogenase (MDH) at 400 uM2003Journal of medicinal chemistry, Oct-09, Volume: 46, Issue:21
Identification and prediction of promiscuous aggregating inhibitors among known drugs.
AID52790Inhibition of chymotrypsin at 250 uM2003Journal of medicinal chemistry, Oct-09, Volume: 46, Issue:21
Identification and prediction of promiscuous aggregating inhibitors among known drugs.
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).
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).
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).
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).
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).
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).2014Journal of biomolecular screening, Jul, Volume: 19, Issue:6
A High-Throughput Assay to Identify Inhibitors of the Apicoplast DNA Polymerase from Plasmodium falciparum.
AID1794808Fluorescence-based screening to identify small molecule inhibitors of Plasmodium falciparum apicoplast DNA polymerase (Pf-apPOL).
AID1224864HCS microscopy assay (F508del-CFTR)2016PloS one, , Volume: 11, Issue:10
Increasing the Endoplasmic Reticulum Pool of the F508del Allele of the Cystic Fibrosis Transmembrane Conductance Regulator Leads to Greater Folding Correction by Small Molecule Therapeutics.
AID1159550Human Phosphogluconate dehydrogenase (6PGD) Inhibitor Screening2015Nature cell biology, Nov, Volume: 17, Issue:11
6-Phosphogluconate dehydrogenase links oxidative PPP, lipogenesis and tumour growth by inhibiting LKB1-AMPK signalling.
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.
AID977610Experimentally measured binding affinity data (Ki) for protein-ligand complexes derived from PDB2002Structure (London, England : 1993), Nov, Volume: 10, Issue:11
Cocrystal structures of diaminopimelate decarboxylase: mechanism, evolution, and inhibition of an antibiotic resistance accessory factor.
AID1811Experimentally measured binding affinity data derived from PDB2002Structure (London, England : 1993), Nov, Volume: 10, Issue:11
Cocrystal structures of diaminopimelate decarboxylase: mechanism, evolution, and inhibition of an antibiotic resistance accessory factor.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (437)

TimeframeStudies, This Drug (%)All Drugs %
pre-199065 (14.87)18.7374
1990's59 (13.50)18.2507
2000's104 (23.80)29.6817
2010's159 (36.38)24.3611
2020's50 (11.44)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 71.46

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 Index71.46 (24.57)
Research Supply Index6.28 (2.92)
Research Growth Index4.77 (4.65)
Search Engine Demand Index234.73 (26.88)
Search Engine Supply Index3.75 (0.95)

This Compound (71.46)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials69 (14.81%)5.53%
Reviews96 (20.60%)6.00%
Case Studies17 (3.65%)4.05%
Observational1 (0.21%)0.25%
Other283 (60.73%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (36)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Study of Patient Concerns and Treatment Satisfaction in Patients Being Treated With Finacea Foam for Rosacea [NCT03193372]2,200 participants (Actual)Observational2017-07-20Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate Safety and Clinical Equivalence of a Generic Azelaic Acid Foam, 15% and the Reference Listed Finacea® (Azelaic Acid) Foam,15% in Patients With Moderate Facial Ro [NCT03287791]Phase 3924 participants (Actual)Interventional2016-07-19Completed
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Taro Product to RLD, and Both Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea [NCT03689010]Phase 11,116 participants (Actual)Interventional2017-12-12Completed
Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea [NCT05014906]Phase 460 participants (Actual)Interventional2010-05-31Completed
Azelaic Acid Foam 15% in the Treatment of Papulopustula Rosacea: An Evaluation of Photographic Evidence [NCT03418610]Phase 45 participants (Actual)Interventional2017-12-06Completed
Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Study to Investigate Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily in Subjects With Papulopustular Rosacea [NCT01025635]Phase 2401 participants (Actual)Interventional2009-12-31Completed
A 6-week, Vehicle-controlled, Randomized, Double-blind, Parallel-group Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Perioral Dermatitis [NCT00403949]Phase 248 participants (Actual)Interventional2006-11-30Completed
A 12-week Exploratory, Multicenter, Double-blind, Vehicle-controlled Study to Investigate the Efficacy and Safety of Topical Azelaic Acid 15% Foam Twice Daily in Patients With Papulopustular Rosacea [NCT00617903]Phase 283 participants (Actual)Interventional2008-01-31Completed
A Study of Patient Preferences and Drivers of Treatment Satisfaction in Patients With Rosacea [NCT02602470]206 participants (Actual)Observational2015-01-08Completed
Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial [NCT00848458]Phase 2/Phase 370 participants (Anticipated)Interventional2009-01-31Recruiting
Phase IV An Evaluator-Blind Controlled Parallel-Group Study To Assess Efficacy And Safety Of Skinoren® 15% Gel And Differin® 0,1% Gel For The Treatment And Maintenance Treatment Of Facial Acne Vulgaris And Late-Type Acne In Females [NCT01387048]Phase 460 participants (Actual)Interventional2011-08-31Completed
A Randomized, Double-blind, Vehicle Controlled Phase 1 Dermal Safety Study to Evaluate the Sensitizing Potential of Topically Applied Azelaic Acid Pre-foam Formulation in Healthy Subjects Using a Human Repeated Insult Patch Test Design [NCT01430533]Phase 1240 participants (Actual)Interventional2011-09-30Completed
Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma [NCT00927771]Phase 430 participants (Anticipated)Interventional2009-06-30Recruiting
The Influence of Peripheral Androgen Conversion at Toll-like Receptors-2 and CD1d Expressions in Human Keratinocytes as Well as Their Modulation After 6 Months Treatment With Oral Contraceptive. [NCT01850095]60 participants (Anticipated)Interventional2012-03-31Recruiting
Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% vs Finacea® (Azelaic Acid) 15% in Subjects With Healthy Skin [NCT01139047]Phase 477 participants (Actual)Interventional2010-06-30Completed
Split-Face Tolerability Comparison Between MetroGel® (Metronidazole Gel) 1% Versus Finacea® (Azelaic Acid) Gel 15% in Subjects With Healthy Skin [NCT01139008]Phase 480 participants (Actual)Interventional2010-06-30Completed
An Exploratory, Multicenter, Investigator-blinded, Active-controlled Study to Investigate the Efficacy of Topical Azelaic Acid (AzA)15% Gel Twice Daily or Metronidazole Topical Gel 1% Once Daily, Plus Anti-inflammatory Dose Doxycycline (40mg) Once Daily i [NCT00855595]Phase 4207 participants (Actual)Interventional2009-02-28Completed
A Randomized, Double-blind, Vehicle-controlled Phase 1 Dermal Safety Study Using a 21 Day Cumulative Irritant Patch Test Design to Evaluate the Local Tolerability of Azelaic Acid Pre-Foam Formulation in Healthy Volunteers [NCT01430312]Phase 140 participants (Actual)Interventional2011-09-30Completed
Efficacy and Safety of Finacea in the Treatment of Post-Inflammatory Hyperpigmentation and Acne Vulgaris [NCT01038869]Phase 420 participants (Actual)Interventional2009-12-31Completed
A Multicenter, Double-Blind Clinical Trial to Assess the Efficacy and Tolerability of Topical Azelaic Acid 15% Gel Once Daily Compared to Topical Azelaic Acid 15% gelTwice Daily in Subjects With Papulopustular Rosacea [NCT00417937]Phase 498 participants (Actual)Interventional2007-01-31Completed
A Double-Blind, Randomized, Vehicle-Controlled, Six-Week Exploratory Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Seborrheic Dermatitis of the Face [NCT00408330]Phase 248 participants (Actual)Interventional2006-12-31Completed
A 12-week, Randomized, Double-blind, Multicenter Study Comparing the Clinical Efficacy and Safety of Azelaic Acid 15% Gel (SH H 655 BA) With Its Vehicle (SH H 655 PBA) in Patients With Mild to Moderate Acne. [NCT00031096]Phase 3879 participants (Actual)Interventional2002-01-31Completed
A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel-group Clinical Trial to Assess the Safety and Efficacy of Azelaic Acid Foam, 15% Topically Applied Twice Daily for 12 Weeks in Subjects With Papulopustular Rosacea [NCT01555463]Phase 3961 participants (Actual)Interventional2012-09-30Completed
Investigator-blinded, Randomized, Cross-over, Multiple Dose Phase I Study on Safety and Pharmacokinetics of Topically Applied Azelaic Acid Foam, 15% Compared to Azelaic Acid Gel, 15% in Subjects With Papulopustular Rosacea [NCT01257919]Phase 121 participants (Actual)Interventional2011-01-31Completed
The Effect of Azelaic Acid (Financea Gel 15%) on Demodex Folliculorum Counts in Adult Subjects With Mild to Moderate Papulopustular Rosacea [NCT03035955]Phase 2/Phase 320 participants (Actual)Interventional2010-12-31Completed
A Multicenter, Randomized, Controlled, Double-masked, Crossover Design Study to Compare Efficacy and Assess Safety of CD07805/47 Gel 0.5% Applied Once Daily vs Azelaic Acid Gel 15% Applied Twice Daily in Subjects With Erythema of Rosacea [NCT01659853]Phase 370 participants (Actual)Interventional2012-09-30Completed
Finacea 15% and Brimonidine 0.33% Gel in the Treatment of Rosacea - A Pilot Study [NCT02147691]Phase 422 participants (Actual)Interventional2014-05-31Completed
[NCT02800148]Phase 3667 participants (Actual)Interventional2016-11-30Completed
A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension C [NCT01494467]Phase 3688 participants (Actual)Interventional2011-12-31Completed
A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension C [NCT01493687]Phase 3683 participants (Actual)Interventional2011-12-31Completed
A Multi-centre, Single-blind, Parallel Group, Clinical Evaluation of the Efficacy and Safety of Clindamycin 1% / Benzoyl Peroxide 3% and Azelaic Acid 20% in the Topical Treatment of Mild to Moderate Acne Vulgaris [NCT02058628]Phase 4222 participants (Actual)Interventional2014-02-21Completed
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Azeliac Acid Gel and Active Treatments to a Placebo Control in the Treatment of Moderate Facial Rosacea. [NCT03094403]Phase 11,000 participants (Actual)Interventional2016-07-01Completed
A Pilot Study of Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia [NCT05416333]Early Phase 115 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Combination Finacea Gel and Vascular Nd:Yag Laser Therapy for Mild to Moderate Rosacea [NCT01631656]10 participants (Actual)Interventional2010-07-31Completed
A Multicenter, Double-blind, Randomized, Parallel-group, Vehicle-Controlled Study to Evaluate the Safety and Clinical Equivalence of a Generic Azelaic Acid Gel, 15% and the Reference Listed Finacea® (Azelaic Acid) Gel, 15% in Patients With Moderate Facial [NCT02120924]Phase 31,009 participants (Actual)Interventional2013-07-31Completed
Comparative Efficacy of Azelaic Acid 20% Cream Versus Hydroquinone 4% Cream as an Adjuvant to Oral Tranexamic Acid in Melasma [NCT05887219]Phase 150 participants (Actual)Interventional2022-11-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00617903 (19) [back to overview]Investigator's Rating of Overall Improvement at End of Study
NCT00617903 (19) [back to overview]Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12
NCT00617903 (19) [back to overview]Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)
NCT00617903 (19) [back to overview]Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)
NCT00617903 (19) [back to overview]Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)
NCT00617903 (19) [back to overview]Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12
NCT00617903 (19) [back to overview]Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)
NCT00617903 (19) [back to overview]Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12
NCT00617903 (19) [back to overview]Patients' Opinion on Cosmetic Acceptability at End of Study
NCT00617903 (19) [back to overview]Patients' Rating of Overall Improvement at End of Study
NCT00855595 (16) [back to overview]Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)
NCT00855595 (16) [back to overview]Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)
NCT00855595 (16) [back to overview]Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)
NCT00855595 (16) [back to overview]Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)
NCT00855595 (16) [back to overview]Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12
NCT00855595 (16) [back to overview]Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2
NCT00855595 (16) [back to overview]Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4
NCT00855595 (16) [back to overview]Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6
NCT00855595 (16) [back to overview]Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8
NCT00855595 (16) [back to overview]Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)
NCT00855595 (16) [back to overview]Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)
NCT00855595 (16) [back to overview]Investigator Rating of Overall Improvement at End of Study (Week 12)
NCT00855595 (16) [back to overview]Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)
NCT00855595 (16) [back to overview]Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)
NCT00855595 (16) [back to overview]Patient Opinion of Local Tolerability
NCT00855595 (16) [back to overview]Patient Rating of Overall Improvement at End of Study (Week 12)
NCT01025635 (4) [back to overview]Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
NCT01025635 (4) [back to overview]Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)
NCT01025635 (4) [back to overview]Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)
NCT01025635 (4) [back to overview]Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
NCT01038869 (5) [back to overview]Percentage Change in Total Lesion Counts
NCT01038869 (5) [back to overview]Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)
NCT01038869 (5) [back to overview]Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)
NCT01038869 (5) [back to overview]Tolerability Assessments as Measured by the Number of Participants With Side Effects
NCT01038869 (5) [back to overview]Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution
NCT01139008 (3) [back to overview]6 Question Subject Preference Survey at Week 3
NCT01139008 (3) [back to overview]Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3
NCT01139008 (3) [back to overview]Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22.
NCT01139047 (3) [back to overview]6 Question Subject Preference Survey at Week 3
NCT01139047 (3) [back to overview]Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3
NCT01139047 (3) [back to overview]Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22
NCT01493687 (3) [back to overview]Absolute Change in Inflammatory Lesion Count
NCT01493687 (3) [back to overview]Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
NCT01493687 (3) [back to overview]Success Rate
NCT01494467 (3) [back to overview]Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
NCT01494467 (3) [back to overview]Absolute Change in Inflammatory Lesion Count
NCT01494467 (3) [back to overview]Success Rate
NCT01555463 (18) [back to overview]Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)
NCT01555463 (18) [back to overview]Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)
NCT01555463 (18) [back to overview]Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)
NCT01555463 (18) [back to overview]Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
NCT01555463 (18) [back to overview]Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)
NCT01555463 (18) [back to overview]Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)
NCT01555463 (18) [back to overview]Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score
NCT01555463 (18) [back to overview]Participants' Global Assessment of Tolerability at End of Treatment
NCT01555463 (18) [back to overview]Participants' Global Assessment of Treatment Response at End of Treatment
NCT01555463 (18) [back to overview]Participants' Opinion on Cosmetic Acceptability at End of Treatment
NCT01555463 (18) [back to overview]Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
NCT01555463 (18) [back to overview]Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)
NCT01555463 (18) [back to overview]Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
NCT01555463 (18) [back to overview]Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
NCT01555463 (18) [back to overview]Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment
NCT01555463 (18) [back to overview]Change From Baseline in Index Value at End of Treatment
NCT01555463 (18) [back to overview]Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score
NCT01555463 (18) [back to overview]Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)
NCT01631656 (1) [back to overview]IGA of Improvement
NCT01659853 (2) [back to overview]Composite Success
NCT01659853 (2) [back to overview]Onset of Action
NCT02058628 (13) [back to overview]Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 - Superiority Analysis
NCT02058628 (13) [back to overview]Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count
NCT02058628 (13) [back to overview]Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12
NCT02058628 (13) [back to overview]Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12
NCT02058628 (13) [back to overview]Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12
NCT02058628 (13) [back to overview]Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12
NCT02058628 (13) [back to overview]Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12
NCT02058628 (13) [back to overview]Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12
NCT02058628 (13) [back to overview]Number of Participants With Participant Global Change Assessment Score 12 Weeks
NCT02058628 (13) [back to overview]Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)
NCT02058628 (13) [back to overview]Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs) Related to Study Medication
NCT02058628 (13) [back to overview]Number of Treatment Adherent Participants at Week 12
NCT02058628 (13) [back to overview]Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12
NCT02120924 (1) [back to overview]Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts.
NCT02147691 (20) [back to overview]VAS
NCT02147691 (20) [back to overview]VAS
NCT02147691 (20) [back to overview]Visual Analog Scale (VAS)
NCT02147691 (20) [back to overview]Lesion Count
NCT02147691 (20) [back to overview]Dermatology Life Quality Index (DLQI)
NCT02147691 (20) [back to overview]Clinician's Erythema Assessment
NCT02147691 (20) [back to overview]Dermatology Life Quality Index (DLQI)
NCT02147691 (20) [back to overview]DLQI
NCT02147691 (20) [back to overview]DLQI
NCT02147691 (20) [back to overview]Erythema
NCT02147691 (20) [back to overview]Erythema
NCT02147691 (20) [back to overview]Erythema
NCT02147691 (20) [back to overview]Erythema Visual Analog Scale (VAS) Assessment (Subject)
NCT02147691 (20) [back to overview]IGA
NCT02147691 (20) [back to overview]IGA
NCT02147691 (20) [back to overview]IGA
NCT02147691 (20) [back to overview]Investigator Global Assessment (IGA) at Baseline
NCT02147691 (20) [back to overview]Lesion Counts
NCT02147691 (20) [back to overview]Lesion Counts
NCT02147691 (20) [back to overview]Lesion Counts
NCT02800148 (1) [back to overview]Percent Change (Reduction) of Lesion Count From Day 1
NCT03035955 (1) [back to overview]Demodex Count
NCT03287791 (2) [back to overview]Percentage of Participants With Treatment Success Based on IGE Score
NCT03287791 (2) [back to overview]Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12

Investigator's Rating of Overall Improvement at End of Study

Investigator's rating of overall improvement: 1 - excellent improvement; 2 - marked improvement; 3 - moderate improvement; 4 - no change; 5 - deterioration (NCT00617903)
Timeframe: At End of Study (Week 12)

,
InterventionPercentage of participants (Number)
Excellent ImprovementMarked ImprovementModerate ImprovementNo ImprovementDeterioration
Azelaic Acid Foam, 15% (BAY39-6251)34.223.731.67.92.6
Vehicle Foam40.017.527.512.52.5

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Percent Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)

(NCT00617903)
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionPercent change in Inflammatory lesions (Mean)
Week 4Week 8Week 12End of Study
Azelaic Acid Foam, 15% (BAY39-6251)-49.5-62.7-75.1-71.2
Vehicle Foam-37.7-62.8-74.8-65.3

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Percentage of Participants With Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe (NCT00617903)
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionPercentage of participants (Number)
Week 4-clear or almost clearWeek 4-mildWeek 4-moderateWeek 4-severeWeek 8-clear or almost clearWeek 8-mildWeek 8-moderateWeek 8-severeWeek 12-clear or almost clearWeek 12-mildWeek 12-moderateWeek 12-severeEnd of Study-clear or almost clearEnd of Study-mildEnd of Study-moderateEnd of Study-severe
Azelaic Acid Foam, 15% (BAY39-6251)5.130.851.312.813.236.842.17.918.442.134.25.317.141.534.17.3
Vehicle Foam042.150.07.910.832.445.910.825.722.945.75.721.421.452.44.8

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Percentage of Participants With IGA Based Patient Response at Weeks 4, 8, 12 and End of Study (LOCF)

IGA based Patient response was defined as an IGA score of clear, minimal or mild (0, 1, 2). (NCT00617903)
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionPercentage of participants (Number)
Week 4Week 8Week 12End of Study
Azelaic Acid Foam, 15% (BAY39-6251)38.555.373.770.7
Vehicle Foam34.251.462.954.8

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Percentage of Participants With IGA Based Therapeutic Success at Weeks 4, 8 and 12

"IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success was defined as an IGA score of clear or minimal (0 to 1).)." (NCT00617903)
Timeframe: At Weeks 4, 8 and 12

,
InterventionPercentage of participants (Number)
Week 4Week 8Week 12
Azelaic Acid Foam, 15% (BAY39-6251)20.536.847.4
Vehicle Foam13.235.154.3

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Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). (NCT00617903)
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionPercentage of participants (Number)
Week 4-clearWeek 4-minimalWeek 4-mildWeek 4-mild to moderateWeek 4-moderateWeek 4-moderate to severeWeek 4-severeWeek 8-clearWeek 8-minimalWeek 8-mildWeek 8-mild to moderateWeek 8-moderateWeek 8-moderate to severeWeek 8-severeWeek 12-clearWeek 12-minimalWeek 12-mildWeek 12-mild to moderateWeek 12-moderateWeek 12-moderate to severeWeek 12-severeEnd of Study-clearEnd of Study-minimalEnd of Study-mildEnd of Study-mild to moderateEnd of Study-moderateEnd of Study-moderate to severeEnd of Study-severe
Azelaic Acid Foam, 15% (BAY39-6251)020.517.923.130.87.707.928.918.421.115.87.9010.536.826.321.105.309.836.624.419.507.32.4
Vehicle Foam2.610.521.121.126.313.25.38.127.016.216.221.68.12.717.137.18.620.08.68.6016.731.07.119.011.914.30

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Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Study (LOCF: Last Observation Carried Forward)

(NCT00617903)
Timeframe: Baseline and End of Study (Week 12)

InterventionInflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)-11.7
Vehicle Foam-10.8

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Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Study (LOCF)

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). (NCT00617903)
Timeframe: At End of Study (Week 12)

InterventionPercentage of participants (Number)
Azelaic Acid Foam, 15% (BAY39-6251)46.3
Vehicle Foam47.6

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Change From Baseline in Erythema Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe (NCT00617903)
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionScores on a scale (Mean)
Week 4Week 8Week 12End of Study
Azelaic Acid Foam, 15% (BAY39-6251)-0.3-0.6-0.8-0.8
Vehicle Foam-0.4-0.5-0.7-0.6

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Change From Baseline in IGA Scores at Weeks 4, 8, 12 and End of Study (LOCF)

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3- Mild to Moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe / Therapeutic success is defined as an IGA score of clear or minimal (0 to 1). (NCT00617903)
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionScores on a scale (Mean)
Week 4Week 8Week 12End of Study
Azelaic Acid Foam, 15% (BAY39-6251)-1.0-1.6-2.1-2.0
Vehicle Foam-0.7-1.3-1.9-1.7

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Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe (NCT00617903)
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionScores on a scale (Mean)
Week 4Week 8Week 12End of Study
Azelaic Acid Foam, 15% (BAY39-6251)0.0-0.1-0.2-0.1
Vehicle Foam-0.1-0.3-0.3-0.2

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Grouped Change From Baseline in Erythema Intensity Score at End of Study (LOCF)

Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe (NCT00617903)
Timeframe: Baseline and End of Study (Week 12)

,
InterventionPercentage of participants (Number)
ImprovedNo changeWorse
Azelaic Acid Foam, 15% (BAY39-6251)61.036.62.4
Vehicle Foam47.645.27.1

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Grouped Change From Baseline in Erythema Intensity Score at Weeks 4, 8 and 12

Erythema intensity score: 1 - Clear or almost clear; 2 - Mild; 3 - Moderate; 4 - Severe (NCT00617903)
Timeframe: Baseline and Weeks 4, 8 and 12

,
InterventionPercentage of participants (Number)
Week 4-ImprovedWeek 4-No changeWeek 4-WorseWeek 8-ImprovedWeek 8-No changeWeek 8-WorseWeek 12-ImprovedWeek 12-No changeWeek 12-Worse
Azelaic Acid Foam, 15% (BAY39-6251)35.959.05.150.050.0063.234.22.6
Vehicle Foam42.152.65.348.640.510.854.337.18.6

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Grouped Change From Baseline in Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe (NCT00617903)
Timeframe: Baseline and Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionPercentage of participants (Number)
Week 4-ImprovedWeek 4-No changeWeek 4-WorseWeek 8-ImprovedWeek 8-No changeWeek 8-WorseWeek 12-ImprovedWeek 12-No changeWeek 12-WorseEnd of Study-ImprovedEnd of Study-No changeEnd of Study-Worse
Azelaic Acid Foam, 15% (BAY39-6251)5.192.32.610.589.5015.884.2014.685.40
Vehicle Foam10.586.82.627.073.0028.671.4023.876.20

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Percentage of Participants With Telangiectasia Intensity Scores at Weeks 4, 8, 12 and End of Study (LOCF)

Telangiectasia intensity score: 1 - None; 2 - Mild; 3 - Moderate; 4 - Severe (NCT00617903)
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionPercentage of participants (Number)
Week 4-noneWeek 4-mildWeek 4-moderateWeek 4-severeWeek 8-noneWeek 8-mildWeek 8-moderateWeek 8-severeWeek 12-noneWeek 12-mildWeek 12-moderateWeek 12-severeEnd of Study-noneEnd of Study-mildEnd of Study-moderateEnd of Study-severe
Azelaic Acid Foam, 15% (BAY39-6251)035.964.10042.157.902.642.155.302.441.556.10
Vehicle Foam2.642.155.305.456.837.802.962.934.302.459.538.10

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Mean of Inflammatory Lesion Count Per Participant at Weeks 4, 8, 12 and End of Study (LOCF)

(NCT00617903)
Timeframe: At Weeks 4, 8, 12 and End of Study (LOCF)

,
InterventionInflammatory lesions (Mean)
Week 4Week 8Week 12End of Study
Azelaic Acid Foam, 15% (BAY39-6251)9.16.84.36.3
Vehicle Foam11.76.64.66.8

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Nominal Change From Baseline in Inflammatory Lesion Count Per Participant at Weeks 4, 8 and 12

(NCT00617903)
Timeframe: Baseline and Weeks 4, 8 and 12

,
InterventionInflammatory lesions (Mean)
Week 4Week 8Week 12
Azelaic Acid Foam, 15% (BAY39-6251)-7.5-9.9-12.4
Vehicle Foam-5.8-10.3-12.4

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Patients' Opinion on Cosmetic Acceptability at End of Study

Patient's opinion on cosmetic acceptability: 1 - very good; 2 - good; 3 - satisfactory; 4 - poor; 5 - no opinion (NCT00617903)
Timeframe: At End of Study (Week 12)

,
InterventionPercentage of participants (Number)
Very GoodGoodSatisfactoryPoorNo Opinion
Azelaic Acid Foam, 15% (BAY39-6251)42.136.810.55.35.3
Vehicle Foam35.037.55.010.012.5

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Patients' Rating of Overall Improvement at End of Study

Patient's rating of overall improvement: 1 - excellent; 2 - good; 3 - fair; 4 - no improvement; 5 - worse (NCT00617903)
Timeframe: At End of Study (Week 12)

,
InterventionPercentage of participants (Number)
Excellent ImprovementGood ImprovementFair ImprovementNo ImprovementWorse
Azelaic Acid Foam, 15% (BAY39-6251)36.828.921.15.37.9
Vehicle Foam27.522.522.520.07.5

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Percent Change From Baseline in IL Count at Weeks 2, 4, 6, 8 and 12 (LOCF)

NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) (NCT00855595)
Timeframe: Baseline and Week 2, 4, 6, 8 and 12

,
InterventionPercent of inflammatory lesions (Mean)
Week 2Week 4Week 6Week 8Week 12
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)-50.7-64.9-72.4-76.4-80.2
Metronidazole (Metrogel) Plus Doxycycline (Oracea)-43.0-56.9-64.5-71.6-75.1

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Percentage of Participants With at Least a 25%, 50%, or 75% Improvement in Facial IL Counts From Baseline to Weeks 2, 4, 6, 8 and 12 (LOCF)

(NCT00855595)
Timeframe: Baseline and Weeks 2, 4, 6, 8 and 12

,
InterventionPercentage of participants (Number)
Week 2, ≥25% improvementWeek 2, ≥50% improvementWeek 2, ≥75% improvementWeek 4, ≥25% improvementWeek 4, ≥50% improvementWeek 4, ≥75% improvementWeek 6, ≥25% improvementWeek 6, ≥50% improvementWeek 6, ≥75% improvementWeek 8, ≥25% improvementWeek 8, ≥50% improvementWeek 8, ≥75% improvementWeek 12, ≥25% improvementWeek 12, ≥50% improvementWeek 12, ≥75% improvement
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)84.961.320.890.675.544.395.384.954.795.388.767.096.289.668.9
Metronidazole (Metrogel) Plus Doxycycline (Oracea)77.247.517.881.264.440.691.178.243.690.187.155.491.185.165.3

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Percentage of Participants With IGA Based Patient Response at Weeks 2, 4, 6, 8 and 12 (LOCF)

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Patient response is defined as an IGA score of clear, minimal, or mild (0, 1, or 2) (NCT00855595)
Timeframe: Weeks 2, 4, 6, 8 and 12

,
InterventionPercentage of participants (Number)
Week 2Week 4Week 6Week 8Week 12
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)32.155.760.472.678.3
Metronidazole (Metrogel) Plus Doxycycline (Oracea)27.744.653.559.472.3

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Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at Weeks 2, 4, 6, 8 and 12 (LOCF)

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information) / Therapeutic success is defined as an IGA score of clear or minimal (0 or 1). (NCT00855595)
Timeframe: Weeks 2, 4, 6, 8 and 12

,
InterventionPercentage of participants (Number)
Week 2Week 4Week 6Week 8Week 12
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)13.232.145.350.962.3
Metronidazole (Metrogel) Plus Doxycycline (Oracea)7.926.727.739.652.5

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Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 12

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). (NCT00855595)
Timeframe: At Week 12

,
InterventionPercentage of participants (Number)
0 - Clear1 - Minimal2 - Mild3 - Mild to moderate4 - Moderate5 - Moderate to severe6 - Severe
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)30.232.116.012.36.61.90.9
Metronidazole (Metrogel) Plus Doxycycline (Oracea)22.829.719.813.910.93.00

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Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 2

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). (NCT00855595)
Timeframe: At Week 2

,
InterventionPercentage of participants (Number)
0 - Clear1 - Minimal2 - Mild3 - Mild to moderate4 - Moderate5 - Moderate to severe6 - Severe
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)0.912.318.933.025.59.40
Metronidazole (Metrogel) Plus Doxycycline (Oracea)1.06.919.831.727.710.92.0

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Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 4

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). (NCT00855595)
Timeframe: At Week 4

,
InterventionPercentage of participants (Number)
0 - Clear1 - Minimal2 - Mild3 - Mild to moderate4 - Moderate5 - Moderate to severe6 - Severe
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)7.524.523.624.515.14.70
Metronidazole (Metrogel) Plus Doxycycline (Oracea)6.919.817.823.820.89.91.0

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Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 6

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). (NCT00855595)
Timeframe: At Week 6

,
InterventionPercentage of participants (Number)
0 - Clear1 - Minimal2 - Mild3 - Mild to moderate4 - Moderate5 - Moderate to severe6 - Severe
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)18.926.415.124.511.33.80
Metronidazole (Metrogel) Plus Doxycycline (Oracea)9.917.825.719.819.86.90

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Percentage of Participants With Respective Disease Severity Measured by IGA Scores at Week 8

IGA categories: 0 - Clear; 1 - Minimal; 2 - Mild; 3 - Mild to moderate; 4 - Moderate; 5 - Moderate to severe; 6 - Severe (refer to Detailed Description field in Protocol section for more information). (NCT00855595)
Timeframe: At Week 8

,
InterventionPercentage of participants (Number)
0 - Clear1 - Minimal2 - Mild3 - Mild to moderate4 - Moderate5 - Moderate to severe6 - Severe
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)18.932.121.714.210.42.80
Metronidazole (Metrogel) Plus Doxycycline (Oracea)13.925.719.823.812.94.00

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Patient Opinion of Cosmetic Acceptability at End of Study (Week 12)

(NCT00855595)
Timeframe: Week 12

,
InterventionPercentage of participants (Number)
Very GoodGoodSatisfactoryPoorNo Opinion
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)52.034.34.908.8
Metronidazole (Metrogel) Plus Doxycycline (Oracea)56.326.08.31.08.3

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Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) at Week 2 (LOCF: Last Observation Carried Forward)

NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) (NCT00855595)
Timeframe: Baseline and Week 2

InterventionInflammatory lesions (Mean)
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)-10.5
Metronidazole (Metrogel) Plus Doxycycline (Oracea)-9.4

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Investigator Rating of Overall Improvement at End of Study (Week 12)

(NCT00855595)
Timeframe: Week 12

,
InterventionPercentage of participants (Number)
Excellent ImprovementMarked ImprovementModerate ImprovementNo changeDeterioration
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)46.635.912.64.90
Metronidazole (Metrogel) Plus Doxycycline (Oracea)42.334.017.56.20

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Nominal Change From Baseline in IL Count at Weeks 4, 6, 8 and 12 (LOCF)

NOTE: Negative mean values represent an improvement (decrease of inflammatory lesions) (NCT00855595)
Timeframe: Baseline and Week 4, 6, 8 and 12

,
InterventionInflammatory lesions (Mean)
Week 4Week 6Week 8Week 12
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)-13.2-14.8-15.5-16.2
Metronidazole (Metrogel) Plus Doxycycline (Oracea)-12.4-14.1-15.6-16.2

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Number of Inflammatory Lesions at Weeks 2, 4, 6, 8 and 12 (LOCF)

(NCT00855595)
Timeframe: Week 2, 4, 6, 8 and 12

,
InterventionInflammatory lesions (Mean)
Week 2Week 4Week 6Week 8Week 12
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)10.17.45.95.14.4
Metronidazole (Metrogel) Plus Doxycycline (Oracea)12.59.57.86.45.7

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Patient Opinion of Local Tolerability

(NCT00855595)
Timeframe: Week 12

,
InterventionPercentage of Participants (Number)
ExcellentGoodAcceptable despite minor irritationLess acceptable due to continuous irritationNo opinion
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)53.934.37.82.91.0
Metronidazole (Metrogel) Plus Doxycycline (Oracea)72.915.611.500

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Patient Rating of Overall Improvement at End of Study (Week 12)

(NCT00855595)
Timeframe: Week 12

,
InterventionPercentage of participants (Number)
Excellent ImprovementGood ImprovementFair ImprovementNo ImprovementWorse
Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)51.039.27.82.00
Metronidazole (Metrogel) Plus Doxycycline (Oracea)49.033.315.61.01.0

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Nominal Change From Baseline in Inflammatory Lesion (IL) Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)

(NCT01025635)
Timeframe: Baseline and End of treatment (up to 12 weeks) (LOCF)

InterventionInflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)-13.4
Vehicle Foam-9.5

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Percent Change From Baseline in IL Count (Sum of Papules and Pustules) Per Participant at End of Treatment (LOCF)

(NCT01025635)
Timeframe: At End of treatment (up to 12 weeks) (LOCF)

InterventionPercentage of Inflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)-62.5
Vehicle Foam-47.8

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Percentage of Participants With Investigator's Global Assessment (IGA) Based Patient Response at End of Treatment (LOCF)

The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Subjects achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Subjects with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Subjects who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. (NCT01025635)
Timeframe: At End of treatment (up to 12 weeks) (LOCF)

InterventionPercentage of participants (Number)
Azelaic Acid Foam, 15% (BAY39-6251)69.2
Vehicle Foam57.6

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Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)

The IGA is a static evaluation of the overall severity of papulopustular rosacea at a given time. It consists of 5 scores ranging from clear to severe papulopustular rosacea and allows rapid overall evaluation of disease severity: 1) Clear: virtually no rosacea, ie, no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; residual to mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules; moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal. (NCT01025635)
Timeframe: At End of treatment (up to 12 weeks) (LOCF)

InterventionPercentage of participants (Number)
Azelaic Acid Foam, 15% (BAY39-6251)43.4
Vehicle Foam32.5

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Percentage Change in Total Lesion Counts

Total lesions including inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones). (NCT01038869)
Timeframe: Baseline to 16 weeks

Interventionpercentage of total lesion count (Mean)
Azelaic Acid 15%-92.4

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Percentage of Participants With Improvement in Acne IGA (Investigator Global Assessment)

IGA Assessments at each visit (baseline and follow up) based on a 6 point scale (0= clear through 5 = very severe). Improvement is defined as at least a 1 point improvement. (NCT01038869)
Timeframe: Baseline to 16 weeks

Interventionpercentage of participants (Number)
Azelaic Acid 15% Open Label92

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Percentage of Participants With Improvement in the IGA of Post Inflammatory Hyperpigmentation(PIH)

IGA for PIH assessed on a 7 point scale (0= clear through 6 = severe) with at least a two point improvement (NCT01038869)
Timeframe: Baseline to16 weeks

Interventionpercentage of participants (Number)
Azelaic Acis 15% Open Label100

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Tolerability Assessments as Measured by the Number of Participants With Side Effects

Tolerability parameters assesssed by the presence and degree of peeling, erythema, dryness, oiliness, burning and pruritus (NCT01038869)
Timeframe: 16 weeks

Interventionparticipants (Number)
Azelaic Acid 15%0

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Percentage of Participants With an Improvement in Post Inflammatory Hyperpigmentation (PIH) % Distribution

The % distribution of PIH, evaluated on a scale of 0 = no PIH through 6 = greater than 50% (NCT01038869)
Timeframe: Baseline to 16 weeks

Interventionpercentage of participants (Number)
2 grade improvement1 grade improvement
Azelaic Acid 15%92100

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6 Question Subject Preference Survey at Week 3

Number of participants per response to each question of the Subject Preference Survey at week 3 (NCT01139008)
Timeframe: week 3

Interventionparticipants (Number)
1. Side of face felt better MetroGel®1. Side of face felt better Finacea®1. Side of face both felt same1. Side of face neither felt better1. Side of face Missing2. Overall impression of MetroGel® Very pleasant2. Overall impression of MetroGel® Pleasant2. Overall impression of MetroGel® Okay2. Overall impression of MetroGel® Unpleasant2. Overall impression of MetroGel® Very Unpleasant2. Overall impression of MetroGel® Missing3. Overall impression of Finacea® Very pleasant3. Overall impression of Finacea® Pleasant3. Overall impression of Finacea® Okay3. Overall impression of Finacea® Unpleasant3. Overall impression of Finacea® Very unpleasant3. Overall impression of Finacea® Missing4. Side of face more sensitive MetroGel®4. Side of face more sensitive Finacea®4. Side of face more sensitive both felt same4. Side of face more sensitive Neither4. Side of face more sensitive Missing5. Which side was easier to use MetroGel®?5. Which side was easier to use Finacea®?5. Which side was easier to use both equal?5. Which side was easier to use Neither?5. Which side was easier to use Missing6. Which product tell a friend about MetroGel®?6. Which product tell a friend about Finacea®?6. Which product tell a friend about Both?6. Which product tell a friend about Neither?6. Which product tell a friend about Missing
MetroGel® 1% and Finacea® Gel 15%16203111216253232215332541212271029218213812162625112

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Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3

Number of participants who were a success with regard to worst post-baseline tolerability assessment scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0. (NCT01139008)
Timeframe: baseline to week 3

,
Interventionparticipants (Number)
ErythemaScalingDrynessStinging/Burning
Finacea® Gel 15%11787065
MetroGel® 1%14797172

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Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22.

Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment. (NCT01139008)
Timeframe: Day 22

,
Interventionparticipants (Number)
ErythemaScalingDrynessStinging/Burning
Finacea® Gel 15%29737368
MetroGel® 1%34747372

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6 Question Subject Preference Survey at Week 3

Number of participants per response to each question of the subject preference survey at week 3 (NCT01139047)
Timeframe: 3 weeks

Interventionparticipants (Number)
1. Side of face felt better MetroGel®1. Side of face felt better Finacea®1. Side of face both felt same1. Side of face neither felt better1. Side of face felt better Missing2. Overall impression of MetroGel® Very pleasant2. Overall impression of MetroGel® Pleasant2. Overall impression of MetroGel® Okay2. Overall impression of MetroGel® Unpleasant2. Overall impression of MetroGel® Very unpleasant2. Overall impression of MetroGel® Missing3. Overall impression of Finacea® Very pleasant3. Overall impression of Finacea® Pleasant3. Overall impression of Finacea® Okay3. Overall impression of Finacea® Unpleasant3. Overall impression of Finacea® Very unpleasant3. Overall impression of Finacea® Missing4. Side of face more sensitive MetroGel®4. Side of face more sensitive Finacea®4. Side of face more sensitive both felt same4. Side of face more sensitive Neither4. Side of face more sensitive Missing5. Which side was easier to use MetroGel®?5. Which side was easier to use Finacea®?5. Which side was easier to use both equal?5. Which side was easier to use Neither?5. Which side was easier to use Missing6. Which product tell a friend about MetroGel®?6. Which product tell a friend about Finacea®?6. Which product tell a friend about Both?6. Which product tell a friend about Neither?6. Which product tell a friend about Missing?
MetroGel® 1% and Finacea Gel® 15%21143012033634400526385304321229013135010131132210

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Number of Participants Who Were a Success With Regard to Worst Post-baseline Tolerability Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) From Baseline to Week 3

Number of participants who were a success with regard to worst post-baseline tolerability scores in each of the tolerability assessments at any time point between baseline and week 3. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0. (NCT01139047)
Timeframe: baseline to week 3

,
Interventionparticipants (Number)
ErythemaScalingDrynessStinging/Burning
Finacea Gel® 15%13604834
MetroGel® 1%12614865

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Number of Participants Who Were a Success With Regard to Worst-baseline Tolerability Assessment Scores in Each Assessment (Erythema, Scaling, Dryness, Stinging/Burning) on Day 22

Number of participants who were a success with regard to worst-baseline tolerability assessment scores for each assessment (erythema, scaling, dryness, stinging/burning) on day 22. Tolerability assessments (erythema, scaling, dryness, stinging/burning) are evaluated on a scale from 0 - 4 (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with 0 being best and 4 being worst. Success was defined as a tolerability score of 0 for each assessment. (NCT01139047)
Timeframe: day 22

,
Interventionparticipants (Number)
ErythemaScalingDrynessStinging/Burning
Finacea Gel® 15%33715163
MetroGel® 1%33695077

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Absolute Change in Inflammatory Lesion Count

Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). (NCT01493687)
Timeframe: Baseline to Week 12

InterventionLesion count change (Mean)
CD5024 1% Cream-20.5
CD5024 Vehicle Cream-12.0

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Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)

Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). (NCT01493687)
Timeframe: Baseline to Week 12

InterventionPercentage of change in lesion counts (Mean)
CD5024 1% Cream-64.9
CD5024 Vehicle Cream-41.6

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Success Rate

"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.~Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:~Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)" (NCT01493687)
Timeframe: Week 12

InterventionPercentage of participants (Number)
CD5024 1% Cream38.4
CD5024 Vehicle Cream11.6

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Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)

Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). (NCT01494467)
Timeframe: Baseline to Week 12

InterventionPercentage of change in lesion counts (Mean)
CD5024 1% Cream-65.7
CD5024 Vehicle Cream-43.4

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Absolute Change in Inflammatory Lesion Count

Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek). (NCT01494467)
Timeframe: Baseline to Week 12

InterventionLesion count change (Mean)
CD5024 1% Cream-22.2
CD5024 Vehicle Cream-13.4

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Success Rate

"Percentage of subjects who achieve Clear (Score 0) or Almost Clear (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.~Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:~Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)" (NCT01494467)
Timeframe: Week 12

InterventionPercentage of participants (Number)
CD5024 1% Cream40.1
CD5024 Vehicle Cream18.8

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Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)

The mean (standard deviation) lesion count at the end of treatment is provided. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

InterventionInflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)8.5
Vehicle Foam10.8

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Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)

The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided. (NCT01555463)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks

InterventionPercent change of inflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)-61.6
Vehicle Foam-50.8

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Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)

Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Participants with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. The percentage of responders is presented. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

InterventionPercentage of participants (Number)
Azelaic Acid Foam, 15% (BAY39-6251)66.3
Vehicle Foam54.4

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Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)

Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

InterventionPercentage of participants (Number)
Azelaic Acid Foam, 15% (BAY39-6251)32.1
Vehicle Foam23.4

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Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)

Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into 'improved', 'no change', or 'worsened'. A participant was considered to have an 'improved' erythema rating if the erythema rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each of these categories is presented. (NCT01555463)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks

,
InterventionPercentage of participants (Number)
ImprovedNo changeWorse
Azelaic Acid Foam, 15% (BAY39-6251)61.536.91.7
Vehicle Foam51.346.22.5

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Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)

Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an 'improved' telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each category is presented. (NCT01555463)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks

,
InterventionPercentage of participants (Number)
ImprovedNo changeWorse
Azelaic Acid Foam, 15% (BAY39-6251)27.365.86.8
Vehicle Foam22.669.77.7

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Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score

"The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant's skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: very much (question 7: yes) (score=3), a lot (score=2), a little (score=1), or not at all/not relevant (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment - baseline) in DLQI overall score from baseline to end of treatment <=-5 and >-5 are presented." (NCT01555463)
Timeframe: Baseline and end of treatment, up to 12 weeks

,
InterventionParticipants (Number)
Score change <=-5Score change >-5
Azelaic Acid Foam, 15% (BAY39-6251)107328
Vehicle Foam82349

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Participants' Global Assessment of Tolerability at End of Treatment

At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented. (NCT01555463)
Timeframe: At end of treatment, up to 12 weeks

,
InterventionParticipants (Number)
ExcellentGoodAcceptable despite minor irritationLess acceptable due to continuous irritationNot acceptableNo opinion
Azelaic Acid Foam, 15% (BAY39-6251)1671281121567
Vehicle Foam1651734927711

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Participants' Global Assessment of Treatment Response at End of Treatment

At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented. (NCT01555463)
Timeframe: At end of treatment, up to 12 weeks

,
InterventionParticipants (Number)
Excellent improvementGood improvementFair improvementNo improvementWorse
Azelaic Acid Foam, 15% (BAY39-6251)75174121578
Vehicle Foam421511288427

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Participants' Opinion on Cosmetic Acceptability at End of Treatment

At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented. (NCT01555463)
Timeframe: At end of treatment, up to 12 weeks

,
InterventionParticipants (Number)
Very goodGoodSatisfactoryPoorNo opinion
Azelaic Acid Foam, 15% (BAY39-6251)176112953616
Vehicle Foam124142994621

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Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)

The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

,
InterventionPercentage of participants (Number)
Clear or almost clearMildModerateSevere
Azelaic Acid Foam, 15% (BAY39-6251)9.351.834.24.8
Vehicle Foam8.441.843.16.7

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Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)

Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

,
InterventionPercentage of participants (Number)
Normal skin colorBarely visible skin-lighteningMild skin lighteningModerate skin lighteningSevere skin lightening
Azelaic Acid Foam, 15% (BAY39-6251)80.18.78.32.70.2
Vehicle Foam78.710.57.73.10

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Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)

The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided. (NCT01555463)
Timeframe: At end of treatment (LOCF), up to 12 weeks

,
InterventionPercentage of participants (Number)
ClearMinimalMildModerateSevere
Azelaic Acid Foam, 15% (BAY39-6251)4.627.534.230.23.5
Vehicle Foam4.419.031.038.76.9

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Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment

"The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled best imaginable health state and worst imaginable health state that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented." (NCT01555463)
Timeframe: Baseline and end of treatment, up to 12 weeks

InterventionScores on a scale (Median)
Azelaic Acid Foam, 15% (BAY39-6251)0
Vehicle Foam0

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Change From Baseline in Index Value at End of Treatment

"The EuroQol Group Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4), and extreme problems (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented." (NCT01555463)
Timeframe: Baseline and end of treatment, up to 12 weeks

InterventionScores on a scale (Median)
Azelaic Acid Foam, 15% (BAY39-6251)0.000
Vehicle Foam0.000

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Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score

"The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant's quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are never (score=1), rarely (score=2), sometimes (score=3), often (score=4), or all the time (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented." (NCT01555463)
Timeframe: Baseline and end of treatment, up to 12 weeks

InterventionScores on a scale (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)-6.8
Vehicle Foam-6.4

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Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)

The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided. (NCT01555463)
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeks

InterventionInflammatory lesions (Mean)
Azelaic Acid Foam, 15% (BAY39-6251)-13.2
Vehicle Foam-10.3

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IGA of Improvement

"Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from 0 = Clear or No inflammatory signs of rosacea to 6 = Severe inflammatory signs of rosacea." (NCT01631656)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Azelaic Acid Plus Laser3.1
LASER ONLY3.5

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Composite Success

Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period (NCT01659853)
Timeframe: Hour 6 on Day 15

Interventionpercentage of subjects (Number)
CD07805/47 Gel 0.5% and Vehicle14.3
Azelaic Acid Gel 15%5.7

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Onset of Action

Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application (NCT01659853)
Timeframe: 30 minutes after baseline treatment application on Day 15

Interventionpercentage of subjects (Number)
CD07805/47 Gel 0.5 and Vehicle31.4
Azelaic Acid 15%29.4

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Percentage Change From Baseline (Day 1) of Inflammatory Lesion (IL) Count at Week 4 - Superiority Analysis

A count of IL (papules and pustules, including nasal lesions) was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as Week 4 values minus the Baseline values. Raw data has been presented for outcome measure results; however, p value is derived from the Wilcoxon test mean scores. (NCT02058628)
Timeframe: Baseline (Day 1) and Week 4

InterventionPercent change (Mean)
DUAC®-51.9
SKINOREN®-38.1

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Speed of Onset : Time to 50 Percent Reduction in Total Lesion Count

The average time to 50 percent reduction of the calculated total lesion count was analyzed by determination of the number of days between Baseline and the first visit with a 50 percent reduction of the count. (NCT02058628)
Timeframe: Week 12

InterventionDays (Median)
DUAC®52.0
SKINOREN®55.0

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Absolute Change From Baseline in IL, Non-inflammatory Lesions (NIL) and Calculated Total Lesions to Weeks 2, 4, 8 and 12

A count of IL (papules and pustules, including nasal lesions), NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values. (NCT02058628)
Timeframe: Baseline (Day 1) up to Week 2, 4, 8, 12

,
InterventionLesions (Mean)
IL, WEEK 2IL, WEEK 4IL, WEEK 8IL, WEEK 12NIL, WEEK 2NIL, WEEK 4NIL, WEEK 8NIL, WEEK 12Total lesion, Week 2Total lesion, Week 4Total lesion, Week 8Total lesion, Week 12
DUAC®-10.3-14.2-17.7-19.6-13.7-21.2-26.8-32.0-23.9-35.4-44.4-51.6
SKINOREN®-6.3-9.7-12.7-14.2-8.5-16.0-20.9-23.3-14.8-25.7-33.6-37.5

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Absolute Change From Baseline in Total Score as Per Children's Dermatology Life Quality Index (CDLQI) at Week 2,4,8 and 12

This outcome measure was a measure of QOL. The CDLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The CDLQI was for participants with 12 to 16 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value. (NCT02058628)
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12

,
InterventionScores on a scale (Mean)
Week 2Week 4Week 8Week 12
DUAC®-2.61-2.55-2.68-2.87
SKINOREN®-1.31-1.55-1.67-1.55

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Absolute Change From Baseline in Total Score as Per Dermatology Life Quality Index (DLQI) at Week 2,4,8 and 12

This outcome measure was a measure of quality of life (QOL). The DLQI was used to assess the quality of life at each visit. Participants completed the questionnaire to evaluate how their acne has affected their life. The DLQI is a 10 item questionnaire, which addresses feelings, daily activities, leisure, work, school, personal relationships, and treatment. Each question was scored out of 0-3, as follows: 0- Not at all, 1- A little, 2- A lot, 3- very much, indicating 0 as the least and 3 as the best quality Index. The sub-scale scores of 10 questions were combined and a composite score was presented. The total score ranged from 0 to 30, 0 indicated the least and highest score indicated the best quality Index. The DLQI was for participants with 17 to 45 years of age. Baseline was defined at Visit 1 (Day 1). Change from Baseline is the value at indicated time point minus the Baseline value. (NCT02058628)
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12

,
InterventionScores on a scale (Mean)
Week 2Week 4Week 8Week 12
DUAC®-2.28-3.39-4.04-4.46
SKINOREN®-2.17-3.15-3.38-3.12

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Number of Participants With Change From Baseline in Investigator's Static Global Assessment (ISGA) to Weeks 2,4,8 and 12

ISGA was conducted at all study visits. The area considered for the ISGA was confined to the face. A 0-5 point rating scale was used: 0 means Clear- Clear skin with no IL or NIL, 1 means Almost Clear- Rare NIL with no more than one small IL, 2 means Mild- Some NIL with no more than a few IL (papules/pustules only, no nodular lesions), 3 means Moderate- Up to many NIL and may have some IL, but no more than one small nodular lesion, 4 means Severe- Up to many NIL and IL, but no more than a few nodular lesions and 5 means Very Severe- Many NIL and IL and more than a few nodular lesions, may have cystic lesions. (NCT02058628)
Timeframe: Baseline (Day 1) up to Weeks 2, 4, 8, 12

,
InterventionParticipants (Count of Participants)
Mild (Baseline) to Almost Clear (Week 2)Mild (Baseline) to Moderate (Week 2)Moderate (Baseline) to Almost Clear (Week 2)Moderate (Baseline) to Mild (Week 2)Moderate (Baseline) to Missing (Week 2)Mild (Baseline) to Almost Clear (Week 4)Mild (Baseline) to Moderate (Week 4)Mild (Baseline) to Missing (Week 4)Moderate (Baseline) to Almost Clear (Week 4)Moderate (Baseline) to Mild (Week 4)Moderate (Baseline) to Severe (Week 4)Moderate (Baseline) to Missing (Week 4)Mild (Baseline) to Clear (Week 8)Mild (Baseline) to Almost Clear (Week 8)Mild (Baseline) to Moderate (Week 8)Mild (Baseline) to Missing (Week 8)Moderate (Baseline) to Clear (Week 8)Moderate (Baseline) to Almost Clear (Week 8)Moderate (Baseline) To Mild (Week 8)Moderate (Baseline) to Missing (Week 8)Mild (Baseline) to Clear (Week 12)Mild (Baseline) to Almost Clear (Week 12)Mild (Baseline) to Moderate (Week 12)Mild (Baseline) to Missing (Week 12)Moderate (Baseline) to Clear (Week 12)Moderate (Baseline) to Almost Clear (Week 12)Moderate (Baseline) to Mild (Week 12)Moderate (Baseline) to Severe (Week 12)Moderate (Baseline) to Missing (Week 12)
DUAC®43126281011290221030115323312202193300
SKINOREN®1811408413241001084052721982092622

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Number of Participants With Change From Baseline in Local Tolerability as Per Investigator's Assessment at Weeks 2,4,8,12

Tolerability was assessed by investigator on a 0-3 point rating scale for erythema (0- None, 1- Slight, 2- Some and 3- Very red), dryness (0- None, 1- Slight, 2- Some and 3- Very dry) and peeling (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the baseline visit to post-baseline visits. Change from Baseline is the value at indicated time point minus the Baseline value. (NCT02058628)
Timeframe: Baseline (Day 1) and Weeks 2, 4, 8, 12

,
InterventionParticipants (Count of Participants)
Erythema None (Baseline) To Slight (Week 2)Erythema None (Baseline) To Some (Week 2)Erythema None (Baseline) To Missing (Week 2)Erythema Slight (Basline) To None (Week 2)Erythema Slight (Baseline) To Some (Week 2)Erythema Slight (Baseline) To Missing (Week 2)Erythema Some (Baseline) To None (Week 2)Erythema Some (Baseline) To Slight (Week 2)Erythema Very Red (Baseline) To Slight (Week 2)Erythema Very Red (Baseline) To Some (Week 2)Erythema Missing (Baseline) To None (Week 2)Erythema None (Baseline) To Slight (Week 4)Erythema None (Baseline) To Some (Week 4)Erythema None (Baseline) To Missing (Week 4)Erythema Slight (Baseline) To None (Week 4)Erythema Slight (Baseline) To Some (Week 4)Erythema Slight (Baseline) To Missing (Week 4)Erythema Some (Baseline) To None (Week 4)Erythema Some (Baseline) To Slight (Week 4)Erythema Some (Baseline) To Missing (Week 4)Erythema Very Red (Baseline) To Slight (Week 4)Erythema Very Red (Baseline) To Some (Week 4)Erythema Missing (Baseline) To None (Week 4)Erythema None (Baseline) To Slight (Week 8)Erythema None (Baseline) To Some (Week 8)Erythema None (Baseline) To Missing (Week 8)Erythema Slight (Baseline) To None (Week 8)Erythema Slight (Baseline) To Some (Week 8)Erythema Slight (Baseline) To Missing (Week 8)Erythema Some (Baseline) To None (Week 8)Erythema Some (Baseline) To Slight (Week 8)Erythema Some (Baseline) To Very Red (Week 8)Erythema Some (Baseline) To Missing (Week 8)Erythema Very Red (Baseline) To None (Week 8)Erythema Very Red (Baseline) To Slight (Week 8)Erythema Missing (Baseline) To Slight (Week 8)Erythema None (Baseline) To Slight (Week 12)Erythema None (Baseline) To Missing (Week 12)Erythema Slight (Baseline) To None (Week 12)Erythema Slight (Baseline) To Some (Week 12)Erythema Slight (Baseline) To Very Red (Week 8)Erythema Slight (Baseline) To Missing (Week 12)Erythema Some (Baseline) To None (Week 12)Erythema Some (Baseline) To Slight (Week 12)Erythema Some (Baseline) To Missing (Week 12)Erythema Very Red (Baseline) To None (Week 12)Erythema Very Red (Baseline) To Slight (Week 12)Erythema Missing (Baseline) To Slight (Week 12)Peeling None (Baseline) To Slight (Week 2)Peeling None (Baseline) To Moderate (Week 2)Peeling None (Baseline) To Missing (Week 2)Peeling Slight (Baseline) To None (Week 2)Peeling Slight (Baseline) To Moderate (Week 2)Peeling Moderate (Baseline) To None (Week 2)Peeling Moderate (Baseline) To Slight (Week 2)Peeling Missing (Baseline) To None (Week 2)Peeling None (Baseline) To Slight (Week 4)Peeling None (Baseline) To Missing (Week 4)Peeling Slight (Baseline) To None (Week 4)Peeling Slight (Baseline) To Moderate (Week 4)Peeling Moderate (Baseline) To None (Week 4)Peeling Moderate (Baseline) To Slight (Week 4)Peeling Missing (Baseline) To None (Week 4)Peeling None (Baseline) To Slight (Week 8)Peeling None (Baseline) To Missing (Week 8)Peeling Slight (Baseline) To None (Week 8)Peeling Slight (Baseline) To Missing (Week 8)Peeling Moderate (Baseline) To None (Week 8)Peeling Moderate (Baseline) To Slight (Week 8)Peeling Missing (Baseline) To None (Week 8)Peeling None (Baseline) To Slight (Week 12)Peeling None (Baseline) To Missing (Week 12)Peeling Slight (Baseline) To None (Week 12)Peeling Slight (Baseline) To Missing (Week 12)Peeling Moderate (Baseline) To None (Week 12)Peeling Moderate (Baseline) To Slight (Week 12)Peeling Missing (Baseline) To None (Week 12)Dryness None (Baseline) To Slight (Week 2)Dryness None (Baseline) To Some (Week 2)Dryness None (Baseline) To Missing (Week 2)Dryness Slight (Baseline) To None (Week 2)Dryness Slight (Baseline) To Some (Week 2)Dryness Some (Baseline) To None (Week 2)Dryness Some (Baseline) To Slight (Week 2)Dryness Missing (Baseline) To None (Week 2)Dryness None (Baseline) To Slight (Week 4)Dryness None (Baseline) To Missing (Week 4)Dryness Slight (Baseline) To None (Week 4)Dryness Slight (Baseline) To Some (Week 4)Dryness Some (Baseline) To None (Week 4)Dryness Some (Baseline) To Slight (Week 4)Dryness Missing (Baseline) To None (Week 4)Dryness None (Baseline) To Slight (Week 8)Dryness None (Baseline) To Missing (Week 8)Dryness Slight (Baseline) To None (Week 8)Dryness Slight (Baseline) To Some (Week 8)Dryness Slight (Baseline) To Missing (Week 8)Dryness Some (Baseline) To None (Week 8)Dryness Some (Baseline) To Slight (Week 8)Dryness Missing (Baseline) To None (Week 8)Dryness None (Baseline) To Some (Week 12)Dryness None (Baseline) To Slight (Week 12)Dryness None (Baseline) To Missing (Week 12)Dryness Slight (Baseline) To None (Week 12)Dryness Slight (Baseline) To Some (Week 12)Dryness Slight (Baseline) To Missing (Week 12)Dryness Some (Baseline) To None (Week 12)Dryness Some (Baseline) To Slight (Week 12)Dryness Missing (Baseline) To None (Week 12)
DUAC®110112113101219111831511021110011552891021160210109800111312832219215121193180311701402211412113411921424318319005411201400631
SKINOREN®18101280111120133019113912101922171311201030182222014912101100820101111311001051211001131510109307622012110315011512111500831511330

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Number of Participants With Change From Baseline in Local Tolerability as Per Participant's Assessment at Weeks 2, 4, 8 and 12

Tolerability was assessed by the participants based on a 0-3 point rating scale for stinging/burning (S/B) and pruritus of the face (0- None, 1- Slight, 2- Moderate and 3- Strong). A shift table was provided to deduce how the results are varying from the Baseline visit to post-baseline visits. (NCT02058628)
Timeframe: Baseline (Day 1), Weeks 2, 4, 8 and 12

,
InterventionParticipants (Count of Participants)
S/B None (Baseline) To Slight (Week 2)S/B None (Baseline) To Moderate (Week 2)S/B None (Baseline) To Strong (Week 2)S/B None (Baseline) To Missing (Week 2)S/B Slight (Baseline) To None (Week 2)S/B Slight (Baseline) To Moderate (Week 2)S/B Slight (Baseline) To Strong (Week 2)S/B Moderate (Baseline) To None (Week 2)S/B Moderate (Baseline) To Slight (Week 2)S/B Strong (Baseline) To None (Week 2)S/B Missing (Baseline) To None (Week 2)S/B None (Baseline) To Slight (Week 4)S/B None (Baseline) To Moderate (Week 4)S/B None (Baseline) To Missing (Week 4)S/B Slight (Baseline) To None (Week 4)S/B Slight (Baseline) To Moderate (Week 4)S/B Slight (Baseline) To Strong (Week 4)S/B Moderate (Baseline) To None (Week 4)S/B Moderate (Baseline) To Slight (Week 4)S/B Moderate (Baseline) To Strong (Week 4)S/B Strong (Baseline) To None (Week 4)S/B Missing (Baseline) To Slight (Week 4)S/B None (Baseline) To Slight (Week 8)S/B None (Baseline) To Moderate (Week 8)S/B None (Baseline) To Missing (Week 8)S/B None (Baseline) To Strong (Week 8)S/B Slight (Baseline) To None (Week 8)S/B Slight (Baseline) To Moderate (Week 8)S/B Slight (Baseline) To Strong (Week 8)S/B Moderate (Baseline) To None (Week 8)S/B Moderate (Baseline) To Slight (Week 8)S/B Moderate (Baseline) To Missing (Week 8)S/B Strong (Baseline) To None (Week 8)S/B Missing (Baseline) To None (Week 8)S/B None (Baseline) To Slight (Week 12)S/B None (Baseline) To Moderate (Week 12)S/B None (Baseline) To Strong (Week 12)S/B None (Baseline) To Missing (Week 12)S/B Slight (Baseline) To None (Week 12)S/B Slight (Baseline) To Moderate (Week 12)S/B Slight (Baseline) To Strong (Week 12)S/B Moderate (Baseline) To None (Week 12)S/B Moderate (Baseline) To Slight (Week 12)S/B Strong (Baseline) To Slight (Week 12)S/B Missing (Baseline) To None (Week 12)Pruritus None (Baseline) To Slight (Week 2)Pruritus None (Baseline) To Moderate (Week 2)Pruritus None (Baseline) To Strong (Week 2)Pruritus None (Baseline) To Missing (Week 2)Pruritus Slight (Baseline) To None (Week 2)Pruritus Slight (Baseline) To Moderate (Week 2)Pruritus Slight (Baseline) To Strong (Week 2)Pruritus Moderate (Baseline) To None (Week 2)Pruritus Moderate (Baseline) To Slight (Week 2)Pruritus Missing (Baseline) To None (Week 2)Pruritus None (Baseline) To Slight (Week 4)Pruritus None (Baseline) To Moderate (Week 4)Pruritus None (Baseline) To Missing (Week 4)Pruritus Slight (Baseline) To None (Week 4)Pruritus Slight (Baseline) To Moderate (Week 4)Pruritus Slight (Baseline) To Strong (Week 4)Pruritus Moderate (Baseline) To None (Week 4)Pruritus Moderate (Baseline) To Slight (Week 4)Pruritus Missing (Baseline) To None (Week 4)Pruritus None (Baseline) To Slight (Week 8)Pruritus None (Baseline) To Missing (Week 8)Pruritus None (Baseline) To Strong (Week 8)Pruritus Slight (Baseline) To None (Week 8)Pruritus Slight (Baseline) To Moderate (Week 8)Pruritus Slight (Baseline) To Strong (Week 8)Pruritus Slight (Baseline) To Missing (Week 8)Pruritus Moderate (Baseline) To None (Week 8)Pruritus Moderate (Baseline) To Slight (Week 8)Pruritus Strong (Baseline) To Moderate (Week 8)Pruritus Missing (Baseline) To None (Week 8)Pruritus None (Baseline) To Slight (Week 12)Pruritus None (Baseline) To Moderate (Week 12)Pruritus None (Baseline) To Strong (Week 12)Pruritus None (Baseline) To Missing (Week 12)Pruritus Slight (Baseline) To None (Week 12)Pruritus Slight (Baseline) To Moderate (Week 12)Pruritus Slight (Baseline) To Strong (Week 12)Pruritus Moderate (Baseline) To None (Week 12)Pruritus Moderate (Baseline) To Slight (Week 12)Pruritus Strong (Baseline) To Slight (Week 12)Pruritus Missing (Baseline) To None (Week 12)
DUAC®1441214300101111212100100151301810010016111180010011440213512111422172022113302140031011110022203101
SKINOREN®2384010221310296191123110214511011121101952493123102771010944103051126122026311142323102231411621410

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Number of Participants With Participant Global Change Assessment Score 12 Weeks

An SGCA was conducted by the participant to assess the efficacy of treatment on Week 2, 4, 8 and 12 as Very Much Improved, Much Improved, Minimally Improved, No Change, Minimally Worse, Much Worse, Very Much Worse and missing. (NCT02058628)
Timeframe: Weeks 2, 4, 8 and 12

,
InterventionParticipants (Count of Participants)
Very much improved (Week 2)Much improved (Week 2)Minimally improved (Week 2)No change (Week 2)Minimally worse (Week 2)Missing (Week 2)Very much improved (Week 4)Much improved (Week 4)Minimally improved (Week 4)No change (Week 4)Minimally worse (Week 4)Missing (Week 4)Very much improved (Week 8)Much improved (Week 8)Minimally improved (Week 8)No change (Week 8)Minimally worse (Week 8)Much worse (Week 8)Very much worse (Week 8)Missing (Week 8)Very much improved (Week 12)Much improved (Week 12)Minimally improved (Week 12)No change (Week 12)Minimally worse (Week 12)Much worse (Week 12)Very much worse (Week 12)Missing (Week 12)
DUAC®45144602548442629543073103144829104020
SKINOREN®2305614600394912711443215811683833175214

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Number of Participants With Participant Satisfaction Score at Week 12 (Simple Grading)

The product acceptability and preference questionnaire (PAP-Q ) served as a patient satisfaction score and was performed only once at the final study visit (ie, after 12 weeks (V5) or earlier in case of premature termination). Severity of each facial acne sign and symptom (scaling, redness, dryness, burning, itching) was based on a 0-5 point rating scale (0- None, 1- Very minimal, 2- Mild, 3- Moderate, 4- Severe, 5- Very severe). (NCT02058628)
Timeframe: Week 12

,
InterventionParticipants (Count of Participants)
Redness, NoneRedness, Very minimalRedness, MildRedness, ModerateRedness, SevereRedness, Very severeRedness, Not applicableDryness, NoneDryness, Very minimalDryness, MildDryness, ModerateDryness, SevereDryness, Very severeDryness, Not applicableBurning, NoneBurning, Very minimalBurning, MildBurning, ModerateBurning, SevereBurning, Very severeBurning, Not applicableItching, NoneItching, Very minimalItching, MildItching, ModerateItching, SevereItching, Very severeItching, Not applicableScaling, NoneScaling, Very minimalScaling, MildScaling, ModerateScaling, SevereScaling, Very severeScaling, Not applicable
DUAC®5532892104332209210908531007317106100692472410
SKINOREN®47201713521412824722150281295013830201132177977401

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Number of Treatment Adherent Participants at Week 12

The general assessment of 'overall satisfaction' with study therapy was assessed at week 12 on a 0-4 point rating scale (0-Very satisfied, 1- Satisfied, 2- Neutral, 3- Unsatisfied and 4- Very unsatisfied). (NCT02058628)
Timeframe: Week 12

,
InterventionParticipants (Count of Participants)
Very satisfiedSatisfiedNeutralUnsatisfiedVery unsatisfied
DUAC®4161410
SKINOREN®264321113

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Percentage Change From Baseline in IL, NIL and Calculated Total Lesions at Weeks 2, 4, 8 and 12

A count of IL (papules and pustules, including nasal lesions),NIL (open and closed comedones) and total lesions was performed at baseline and up to Week 12. Lesion counts were confined to the face. Baseline was defined at Visit 1 (Day 1). Change from Baseline in the number of IL was defined as week 12 values minus the Baseline values. (NCT02058628)
Timeframe: Baseline (Day 1) up to Week 2, 4, 8, 12

,
InterventionPercent change (Mean)
IL, Week 2IL, Week 4IL, Week 8IL, Week 12NIL, Week 2NIL, Week 4NIL, Week 8NIL, Week 12Total lesions, Week 2Total lesions, Week 4Total lesions, Week 8Total lesions, Week 12
DUAC®-37.3-52.2-65.0-72.3-23.5-38.1-48.5-60.6-28.7-43.8-55.2-64.6
SKINOREN®-24.2-38.1-49.1-55.0-14.9-27.0-35.5-42.1-18.4-30.8-40.1-46.1

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Percent Change From Baseline to Week 12 in the Inflammatory (Papules and Pustules) Lesion Counts.

Percent change from baseline to Week 12 in the inflammatory (papules and pustules) lesion counts in PP population. (NCT02120924)
Timeframe: Baseline to Week 12

InterventionPercent change in lesion counts (Mean)
Azelaic Acid, 15% Topical Gel-66.96
Finacea® (Azelaic Acid) Gel, 15%-68.62
Gel Vehicle-38.64

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VAS

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable (NCT02147691)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel3.8
Brimonidine 0.33% Gel4.0

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VAS

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable (NCT02147691)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel4.4
Brimonidine 0.33% Gel4.5

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Visual Analog Scale (VAS)

participant measures erythema on a scale of 0 mm to 10 mm with 0 = to none and 10 = unbearable (NCT02147691)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel4.5
Brimonidine 0.33% Gel5.2

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Lesion Count

(NCT02147691)
Timeframe: Week 4

Interventionlesions (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.1
Brimonidine 0.33% Gel2.1

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Dermatology Life Quality Index (DLQI)

The DLQI is a self-administered questionnaire consisting of 10 questions that measure how much the individual's skin problem has affected their life in the past week. Score ranges 0 through 30, 0 being none and 30 worst possible. (NCT02147691)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel2.6
Brimonidine 0.33% Gel2.9

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Clinician's Erythema Assessment

Erythema will be graded on a scale of 0-4., 0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 very severe. If erythema is much worse on one or several parts of the face, the grade for the worst area will be captured. (NCT02147691)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel2.3
Brimonidine 0.33% Gel2.1

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Dermatology Life Quality Index (DLQI)

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) (NCT02147691)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.8
Brimonidine 0.33% Gel2.6

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DLQI

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) (NCT02147691)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.2
Brimonidine 0.33% Gel2.8

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DLQI

Total scores range from 0 ( no impact on life over the last week) to 30 (maximum impact on life over the last week) (NCT02147691)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.3
Brimonidine 0.33% Gel2.6

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Erythema

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red (NCT02147691)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.3
Brimonidine 0.33% Gel1.2

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Erythema

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red (NCT02147691)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.6
Brimonidine 0.33% Gel1.3

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Erythema

Erythema as measured by the clinician on a scale of 0-4, 0 = no erythema, 1 = slight pinkness, 2 = moderate, definite redness, easily recognized, 3 = severe, marked erythema and 4 = very severe, fiery red (NCT02147691)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.3
Brimonidine 0.33% Gel1.4

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Erythema Visual Analog Scale (VAS) Assessment (Subject)

Subjects will self assess the level of erythema over the previous 24 period using a scale of None (0) through 10 (Unbearable) (NCT02147691)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel5.5
Brimonidine 0.33% Gel5.6

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IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe (NCT02147691)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.3
Brimonidine 0.33% Gel1.4

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IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe (NCT02147691)
Timeframe: Week 4

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.8
Brimonidine 0.33% Gel1.8

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IGA

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe (NCT02147691)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.6
Brimonidine 0.33% Gel1.8

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Investigator Global Assessment (IGA) at Baseline

Assessment of rosacea on a scale of 0-4, 0 = clear, 1= almost clear, 2= mild, 3= moderate and 4 = severe (NCT02147691)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel3
Brimonidine 0.33% Gel3.1

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Lesion Counts

(NCT02147691)
Timeframe: Week 12

Interventionlesions (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel0.7
Brimonidine 0.33% Gel1.2

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Lesion Counts

(NCT02147691)
Timeframe: Week 8

Interventionlesions (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel1.0
Brimonidine 0.33% Gel1.7

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Lesion Counts

The number of inflammatory lesions (papules/pustules) will be counted using the whole face from the hairline edge to the mandibular line (NCT02147691)
Timeframe: Baseline

Interventionlesions (Mean)
Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel3.3
Brimonidine 0.33% Gel4.5

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Percent Change (Reduction) of Lesion Count From Day 1

(NCT02800148)
Timeframe: Day 84

Interventionpercentage of lesion reduction (Mean)
Azelaic Acid Foam61.14
Finacea Foam57.27
Placebo Foam49.43

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Demodex Count

number of demodex at Baseline and Week 4. Only Week 4 reported (NCT03035955)
Timeframe: Week 4

Interventionnumber of demodex (Number)
Azelaic Acid Left/no Treatment Right40
Azelaic Acid Right /no Treatment Left18

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Percentage of Participants With Treatment Success Based on IGE Score

Treatment success defined as an Investigator's Global Evaluation (IGE) score at Week 12 of 0 (clear) or 1 (almost clear). Any other outcome was considered a failure. Participants who were discontinued prematurely from the study due to lack of treatment effect after at least 8 weeks of compliant treatment were considered as treatment failures. The IGE score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). (NCT03287791)
Timeframe: Baseline and 12 Weeks

Interventionpercentage of participants (Number)
Generic Azelaic Acid Foam39.7
Finacea (Azelaic Acid) Foam48.3
Vehicle Foam33.5

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Percent Change From Baseline in the Inflammatory Lesions (Papules and Pustules) Counts at Week 12

All facial papules, pustules, and nodules, located above the jaw line and extending to the hairline, were counted. When counting facial lesions, lesions present on the nose were included. The total count for each lesion type was recorded and the total number of inflammatory lesions (papules and pustules) were calculated. A papule with a pustule on its apex was counted as a pustule. Counts of nodules and cysts were reported separately and not included in the inflammatory counts. Papule defined as inflammatory lesion; small (≤5 mm in diameter), solid palpable lesion, usually with inflamed elevation of the skin that does not contain pus. Pustule defined as inflammatory lesion; small (≤5 mm in diameter), inflamed skin swelling that is filled with pus. Cyst and nodule defined as palpable solid or soft lesion >5 mm in diameter. (NCT03287791)
Timeframe: Baseline, 12 weeks

Interventionpercent change (Mean)
Generic Azelaic Acid Foam-64.28
Finacea (Azelaic Acid) Foam-65.15
Vehicle Foam-57.84

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