Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Information source: Galderma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Adapalene BPO (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Galderma Official(s) and/or principal investigator(s):
Elisabeth ARTHUR, MD, Affiliation: Helendale Dermatology - Rochester NY - 585-266-5420
Alicia BUCKO, MD, Affiliation: Academic Dermatology Associates - Albuquerque NM - 505-247-4220
Paul YAMAUCHI, MD, Affiliation: Clinical Research Specialists, Inc. - Santa Monica CA - 310-828-8887
Steven E. KEMPERS, MD, Affiliation: Minnesota Clinical Study Center - Fridley MN - 763-571-4200
Harald GOLLNICK, MD, Principal Investigator, Affiliation: Otto-von-Guericke University - Magdeburg - Germany
Yvonne FRAMBACH, MD, Affiliation: Universitatsklinikum - Lubeck - Germany
Michael MEURER, MD, Affiliation: Dresden University - Dresden - Germany
Christos ZOUBOULIS, MD, Affiliation: Hautklinik und Immunologisches Zentrum des Städtischen Klinikum - Dessau - Germany
Roland KAUFMANN, MD, Affiliation: Zentrum fur Dermatoligie und Venerologie - Frankfurt - Germany
Thomas SCHWARZ, MD, Affiliation: Klinik fur Dermatologie, Venerologie und Allerologie - Kiel - Germany
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.
Clinical Details
Official title: Efficacy and Safety of Fixed Combination Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Compared to Clindamycin 0.1% / Benzoyl Peroxide 5% Gel in the Treatment of Acne Vulgaris
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percent change from Baseline in total lesion count (sum of non inflammatory and inflammatory lesions) at week 12.
Secondary outcome: Percent change from Baseline in total inflammatory and non inflammatory lesion counts at each intermediate visitGlobal severity assessment at each post Baseline visit
Eligibility
Minimum age: 12 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
Male or female Subjects of any race, between the age of 12 and 35 years inclusive, with
acne vulgaris, meeting specific inclusion/exclusion criteria.
Main inclusion criteria:
1. Male or female Subjects of any race, aged 12 to 35 years inclusive, with facial acne
vulgaris,
2. Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the
face,
3. 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.
Main exclusion criteria:
1. Subjects with acne cystic lesions,
2. Subjects with acne conglobate, acne fulminancy, secondary acne (chloracne,
drug-induced acne, etc.).
Locations and Contacts
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
Additional Information
Starting date: February 2007
Ending date: October 2007
Last updated: May 28, 2008
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