NCT03433378

To Evaluate the Therapeutic Equivalence and Safety of TRETINOIN CREAM, 0.05% and RLD in the Treatment of Acne Vulgaris

A Multi-center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study, Comparing TRETINOIN CREAM, 0.05% to RETIN-A® (TRETINOIN) CREAM, 0.05% and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 700 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

Summary

Bioequivalence study comparing Tretinoin Cream, 0.05% to RETIN-A®.

Detailed description

A Multi-center, Double-Blind, Randomized, Placebo controlled, Parallel-Group study, comparing TRETINOIN CREAM, 0.05% (TARO PHARMACEUTICALS U.S.A., INC.) to RETIN-A® (TRETINOIN) CREAM, 0.05% (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, 0.05%	Tretinoin cream, 0.05%
DRUG	RETIN-A® (tretinoin) cream, 0.05%	RETIN-A® (tretinoin) cream, 0.05%
DRUG	Vehicle of the test product	Vehicle of the test product

Timeline

• Start date: 2017-08-04
• Primary completion: 2018-01-26
• Completion: 2018-01-26
• First posted: 2018-02-14
• Last updated: 2018-05-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study