Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris
Information source: Galderma
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne
Intervention: Adapalene BPO Gel standard daily overnight application (Drug); Adapalene-BPO 3-hour daily application before bedtime (Drug); Adapalene-BPO Gel every other day application (Drug); Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Galderma Official(s) and/or principal investigator(s):
Jerry Tan, MD, Principal Investigator, Affiliation: Windsor, ON, Canada
Overall contact:
Jean-Charles Dhuin, BSc, Phone: 33-4-9295-2921, Email: jean-charles.dhuin@galerma.com
Summary
The purpose of this study is to compare the tolerability of 3 treatment regimens containing
Adapalene 0. 1% / Benzoyl Peroxide 2. 5% Gel with that of Adapalene 0. 1% /Benzoyl Peroxide
2. 5% Gel standard daily overnight application for 12 weeks in the treatment of acne
vulgaris. The efficacy of the four treatment regimens will also be evaluated.
Clinical Details
Official title: Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris
Study design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety Study
Primary outcome: Local tolerability will be analyzed in terms of worsening from Baseline with maximum severity reached.
Eligibility
Minimum age: 12 Years.
Maximum age: 35 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female Subjects of any race, aged 12 to 35 years inclusive
- Subjects with mild or moderate facial acne vulgaris
- Subjects with skin phototype I to IV
Exclusion Criteria:
- Subjects with more than 1 nodules or cysts on the face,
- Subjects with acne conglobata, acne fulminans, secondary acne (chloracne,
drug-induced acne, etc.)
Locations and Contacts
Jean-Charles Dhuin, BSc, Phone: 33-4-9295-2921, Email: jean-charles.dhuin@galerma.com
Galderma Investigational Site, Windsor, Ontario, Canada; Recruiting
Galderma Investigational Site, Montreal, Quebec, Canada; Recruiting
Additional Information
Starting date: April 2009
Ending date: September 2009
Last updated: May 11, 2009
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