NCT04329403

Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

Randomized, Double Blind, Placebo Controlled, Parallel Group Design, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Topical Adapalene Gel, 0.1 % in Healthy Males and Nonpregnant Female Subjects With Acne Vulgaris

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Aurobindo Pharma Ltd · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Detailed description

Bio-Equivalence study with a clinical endpoint in the treatment of acne vulgaris comparing adapalene cream, 0.1% test product versus the reference listed drug (RLD) and placebo (vehicle) control, each administered as one application once a day in the evening for 12 weeks

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene 0.1% Gel	A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
DRUG	Differin 0.1% Topical Gel	A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
OTHER	Placebo	A thin film of the assigned medication to be applied once daily in the evening for 12 weeks

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-01-01
• Completion: 2021-05-01
• First posted: 2020-04-01
• Last updated: 2020-06-26

Regulatory

• FDA-regulated drug study