NCT04724473

A Study Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% and RETIN-A® Cream 0.025% in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1,030 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The bioequivalence and safety of Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A® (Tretinoin) Cream 0.025% in the treatment of acne vulgaris.

Detailed description

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing Tretinoin Cream 0.025% (Taro Pharmaceuticals U.S.A) and RETIN-A® (Tretinoin) Cream 0.025% and Both Active Treatment to a Placebo Control in the Treatment of Acne Vulgaris

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tretinoin Cream 0.025%	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: 2019-12-10
• Primary completion: 2020-11-21
• Completion: 2020-11-21
• First posted: 2021-01-26
• Last updated: 2021-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study