NCT01501799

A Bioequivalence Study With Clinical Endpoints Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) in the Treatment of Mild to Severe Acne Vulgaris

A Multicenter, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Adapalene and Benzoyl Peroxide Topical Gel 0.1%/2.5% (Actavis Mid-Atlantic LLC) To Epiduo™ (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% (Galderma Laboratories, L.P.) and Both Active Treatments to Topical Gel Placebo (Actavis Mid-Atlantic Llc) in the Treatment of Mild to Severe Acne Vulgaris

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 885 (actual)
• Sponsor: Actavis Mid-Atlantic LLC · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

EPIDUO™ (adapalene and benzoyl peroxide) Gel 0.1%/2.5%, marketed by GALDERMA LABORATORIES, L.P., is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of adapalene and benzoyl peroxide topical gel 0.1%/2.5%,and the current study is designed to evaluate the safety and efficacy of this formulation to determine if it is bioequivalent to EPIDUO™.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	adapalene 0.1% and benzoyl peroxide 2.5% topical gel	Dosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks
DRUG	EPIDUO	EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel
DRUG	Placebo (Vehicle Gel)	Vehicle Gel

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-12-29
• Last updated: 2011-12-29

Locations

25 sites across 3 countries: United States, Belize, India