NCT03427554

To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.1% and RLD in the Treatment of Acne Vulgaris

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.1% to RETIN-A® (TRETINOIN) CREAM, 0.1% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence study comparing Tretinoin Cream, 0.1% to RETIN-A®.

Detailed description

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.1% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.1% (VALEANT) and both active treatments to a Placebo Control in the treatment of Acne Vulgaris

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tretinoin cream 0.1%	Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
DRUG	RETIN-A® Cream	RETIN-A® (Tretinoin) Cream (Valeant)
DRUG	Vehicle of the test product	Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)

Timeline

• Start date: 2017-08-21
• Primary completion: 2018-01-26
• Completion: 2018-01-26
• First posted: 2018-02-09
• Last updated: 2018-05-18

Locations

1 site across 1 country: United States