Evaluation of the Effectiveness of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) in Reducing Antibiotic Sensitive and Resistant Strains of P Acnes
Sponsor study identifier
interventional
30
1 country
1
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2009
Actual (reported)Study Completion
July 2009
Actual (reported)The purpose of this study is to evaluate the effectiveness of Epiduo® Gel in reducing antibiotic sensitive and resistant strains of P acnes in vivo.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2009
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 20, 2009
Actual (reported)May 22, 2009
Actual (reported)June 2009
Date type not reportedThis date has not been verified as actual or estimated.
July 2009
Actual (reported)July 2009
Actual (reported)March 16, 2016
Actual (reported)Change From Baseline in Quantitative Bacteriology Measurements at Week 4
Mean log10 values of P. acnes from swabbed skin samples Please note: Quantitative bacteriologic cultures were obtained from the facial skin (forehead) at screening, baseline, week 2 and week 4/early termination. Samples were obtained according to a modification of the technique of Williamson and Kligman. CFUs of P. acnes were counted at the dilution that contained between 10 and 100 CFUs. Total densities of P. acnes were calculated and reported as the average (of both plates) of the log10 CFUs per cm².
Week 4
Worst Post Baseline Tolerability Assessment - Erythema
Week 4
Worst Post Baseline Tolerability Assessment - Dryness
Week 4
Worst Post Baseline Tolerability Assessment - Scaling
Week 4
Worst Post Baseline Tolerability Assessment - Stinging/Burning
Week 4
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel) Other Names: Epiduo® Gel Apply once daily
Apply once daily
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordSkin Study Center
Broomall, Pennsylvania, 19008, United States
Leyden JJ, Preston N, Osborn C, Gottschalk RW. In-vivo Effectiveness of Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel on Antibiotic-sensitive and Resistant Propionibacterium acnes. J Clin Aesthet Dermatol. 2011 May;4(5):22-6.
Ronald W Gottschalk, MD
Galderma R&D
30 participants (actual enrollment reported by the registry).
First Submitted
May 20, 2009
First Posted
May 22, 2009
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
July 2009
Actual (reported)Study Completion
July 2009
Actual (reported)Last Updated
August 1, 2022
Results First Posted
March 16, 2016
Record last verified: 2016-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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