NCT01138735

Epiduo Pediatric Acne Study

A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 285 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 9 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	adapalene/benzoyl peroxide	daily topical application for 12 weeks
DRUG	Topical Gel Vehicle	daily topical application for 12 weeks

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2010-06-07
• Last updated: 2021-02-18
• Results posted: 2013-03-26

Locations

25 sites across 2 countries: United States, Canada