Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
1 other identifier
interventional
272
1 country
4
Brief Summary
The purpose of this study is to demonstrate the non-inferior efficacy of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel when compared to Clindamycin 1% / Benzoyl Peroxide 5% Gel in Subjects with acne vulgaris after a 12-week treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2007
Shorter than P25 for phase_3
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 27, 2007
CompletedFirst Posted
Study publicly available on registry
February 28, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFebruary 17, 2021
August 1, 2008
8 months
February 27, 2007
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
Secondary Outcomes (2)
Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visit
Global severity assessment at each post Baseline visit
Interventions
Eligibility Criteria
You may not qualify if:
- Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne vulgaris,
- Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face,
- Subjects with a minimum of 30 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose.
- Subjects with acne cystic lesions,
- Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne, drug-induced acne, etc.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (4)
Paul YAMAUCHI
Santa Monica, California, 90404, United States
Steven E. KEMPERS
Fridley, Minnesota, 55432, United States
Dr Alicia BUCKO
Albuquerque, New Mexico, 87106, United States
Elisabeth ARTHUR
Rochester, New York, 14609, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
Elisabeth ARTHUR, MD
Helendale Dermatology - Rochester NY - 585-266-5420
Alicia BUCKO, MD
Academic Dermatology Associates - Albuquerque NM - 505-247-4220
Paul YAMAUCHI, MD
Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887
Steven E. KEMPERS, MD
Minnesota Clinical Study Center - Fridley MN - 763-571-4200
- PRINCIPAL INVESTIGATOR
Harald GOLLNICK, MD
Otto-von-Guericke University - Magdeburg - Germany
Yvonne FRAMBACH, MD
Universitatsklinikum - Lubeck - Germany
Michael MEURER, MD
Dresden University - Dresden - Germany
Christos ZOUBOULIS, MD
Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany
Roland KAUFMANN, MD
Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany
Thomas SCHWARZ, MD
Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 27, 2007
First Posted
February 28, 2007
Study Start
February 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
February 17, 2021
Record last verified: 2008-08