This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during...
Date First Received: January 11, 2007
Last Updated: September 10, 2007
Verified by: Galderma, September 2007
Clinical Trial Phase: Phase 3 | Start Date: June 2006
Overall Status: Completed
Estimated Enrollment: 1656
Brief Summary
Official Title: “A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris”
Condition Keyword(s):
Intervention(s):
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study.
The primary objective is to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Adapalene/Benzoyl Peroxide
Outcome Measures for this Clinical Trial
Primary Measures
- Success rate on the Investigator's Global Assessment
- Change in inflammatory lesion counts
- Change in noninflammatory lesion counts
Secondary Measures
- Percent change in lesion counts (inflammatory, noninflammatory, total)
- Change in Investigator's Global Assessment (IGA)
- Subject's assessment of acne
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- A clinical diagnosis of acne vulgaris with facial involvement.
- A minimum of 20 but not more than 50 inflammatory lesions
- A minimum of 30 but not more than 100 noninflammatory lesions
- A score of 3 (Moderate) on the Investigator's Global Assessment Scale
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Galderma
Overall Clinical Trial Officials and Contacts
Michael Graeber, MD Study Director Galderma
Related Publications
References
Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. Review.
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00422240
Study ID Number: RD.06.SPR.18087
ClinicalTrials.gov Identifier: NCT00422240
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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