NCT03650361

Bioequivalence Study of Adapalene Gel 0.3% in Subjects With Facial Acne Vulgaris

A Multi-Center, Double-Blind, Randomized, Three-Arm, Placebo Controlled, Parallel-Group Study, Comparing Adapalene Gel 0.3% To Differin® Gel 0.3% And Both Active Treatments To A Placebo Control In The Treatment Of Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 755 (actual)
• Sponsor: Aleor Dermaceuticals Limited · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% (Aleor Dermaceuticals Limited, India) and Differin® (Adapalene) Gel 0.3% (Galderma Laboratories, LP USA) in the treatment of acne vulgaris.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene Gel 0.3%	Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
DRUG	Differin 0.3% Topical Gel	Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
DRUG	Adapalene Gel 0.3% Vehicle Placebo	Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days

Timeline

• Start date: 2018-09-17
• Primary completion: 2019-02-16
• Completion: 2019-02-16
• First posted: 2018-08-28
• Last updated: 2019-04-26

Locations

10 sites across 2 countries: United States, Belize

Regulatory

• FDA-regulated drug study