NCT02651220

Clinical End Point Study of Generic Adapalene and Benzoyl Peroxide Gel Versus Epiduo® Forte Gel in Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,001 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Therapeutic Equivalence and Safety of adapalene and benzoyl peroxide gel, 0.3%/2.5% (Actavis Laboratories UT, Inc.) to Epiduo® Forte (adapalene and benzoyl peroxide) gel 0.3%/2.5% (Galderma) in the treatment of Acne Vulgaris

Detailed description

Up to 1000 patients 12 to 40 years of age inclusive will be enrolled to have 870 patients in the modified intent-to-treat (mITT) population and 579 patients in the per-protocol (PP) population. The primary inclusion criteria are the presence of ≥ 20 inflammatory lesions (papules and pustules) and ≥ 25 non-inflammatory lesions (opened and closed comedones) and ≤ 2 nodulocystic lesions (i.e., nodules and cysts) on the face and an Investigator's Global Assessment (IGA) score of 3 or 4. Eligible patients will be randomized in a 1:1:1 ratio to one of the three treatments (Test, Reference or Placebo) on Visit 1. Patients will be instructed to apply the first treatment on the evening of enrollment into the study and then continue to apply once daily for the next 83 days (for a total 84 days). Patients will attend the following scheduled clinic visits: * Visit 1 - Screening/Baseline: Day 1 * Visit 2 - Interim Visit: Day 28 ± 4 * Visit 3 - Interim Visit: Day 56 ± 4 * Visit 4 - End of Study: Day 85 ± 4 Efficacy evaluations will be based on dermatological assessments in the clinic. The primary statistical analyses of interest are (1) the percent change from baseline to Week 12 in the number of inflamed (papules/pustules) lesions and non-inflamed (open and closed comedones) lesions. In addition, patients will also be evaluated by the Investigator to determine "Clinical Success" or "Clinical Failure" at Week 12

Conditions

• Acne

Interventions

Type	Name	Description
DRUG	Epiduo® Forte Gel	Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
DRUG	Adapalene and Benzoyl Peroxide Gel	Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
DRUG	placebo gel	vehicle used as placebo

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-04-01
• Completion: 2016-10-01
• First posted: 2016-01-08
• Last updated: 2020-06-23
• Results posted: 2020-06-23

Locations

20 sites across 2 countries: United States, Belize