NCT04797793

A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris

A Double-blind, Randomized, Placebo Controlled Study to Compare Adapalene Gel 0.1% to Differin Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 978 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To demonstrate therapeutic equivalence and safety of adapalene gel 0.1% (Taro Pharmaceuticals U.S.A., Inc.) and Differin® Gel (Adapalene Gel 0.1%, Galderma) in the treatment of acne vulgaris.

Detailed description

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, Adapalene Gel 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and to Differin® Gel (Adapalene 0.1%, Galderma) and both active treatments to a placebo control in the treatment of acne vulgaris

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Adapalene Gel 0.1%	The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
DRUG	Placebo Control	The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
DRUG	Differin® Gel (Adapalene 0.1%, Galderma)	The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.

Timeline

• Start date: 2020-05-18
• Primary completion: 2021-01-08
• Completion: 2021-01-08
• First posted: 2021-03-15
• Last updated: 2021-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study