Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were 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 participant should remain the same during the study. The primary objective was 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.

Key facts

Study ID

NCT00422240

Run by

Galderma R&D

People needed

1668

Starts

2006-06-27

Expected to finish

2007-07-12

Last updated by the study team

2024-04-15

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Miller MD — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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