NCT00599521

Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%

A Multi-Center, Randomized, Double-Blind, Parallel Group Study to Demonstrate the Efficacy and Safety of Adapalene Lotion, 0.1% Compared With Vehicle Lotion in Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,067 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether Adapalene, 0.1% is safe and effective in the treatment of Acne Vulgaris.

Detailed description

This study will compare the efficacy and safety of Adapalene, 0.1% and vehicle in the treatment of subjects with Acne Vulgaris. This is a multi-center, randomized, double-blind, parallel, vehicle controlled study involving subjects with acne vulgaris meeting pre-specified inclusion/exclusion criteria. Male and female subjects, 12 years of age or older, with 20-50 papules and pustules and 30 to 100 non-inflammatory lesions and have an Investigator's Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe) are eligible for enrollment. One nodule may be present at inclusion. Acne lesions are evaluated on the face only. Subjects presenting with facial and truncal acne vulgaris can participate in this study. Subjects will be randomized in a 1:1 ratio to Adapalene, 0.1% or Vehicle.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene lotion 0.1%	Adapalene, 0.1% will be applied topically to the face, once a day, for 12 weeks
DRUG	Adapalene Lotion Vehicle	Vehicle will be applied topically to the face, once a day, for 12 weeks

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2008-01-23
• Last updated: 2021-02-18
• Results posted: 2011-04-19

Locations

34 sites across 2 countries: United States, Canada