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

Early Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Tretinoin cream, 0.05%; Drug: Vehicle of the test product; Drug: RETIN-A® (tretinoin) cream, 0.05%

• Registration Number: NCT03433378
• Lead Sponsor: Taro Pharmaceuticals USA

Brief 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

Study Timeline

• Study Start: 2017-08-04
• Primary Completion: 2018-01-26
• Study Completion: 2018-01-26
• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-14
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

• Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA) (per Table 1 below).

Exclusion Criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
• Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tretinoin cream, 0.05%	Tretinoin cream, 0.05%	Apply once a day application, under at-home use conditions.
Vehicle of the test product	Vehicle of the test product	Apply once a day application, under at-home use conditions.
RETIN-A® (tretinoin) cream, 0.05%	RETIN-A® (tretinoin) cream, 0.05%	Apply once a day application, under at-home use conditions.

Primary Outcome Measures

Name	Time	Method
Demonstration of Bioequivalence	12 weeks	Demonstration of Bioequivalence in Percent change in inflammatory and non-inflammatory lesion counts

Trial Locations

Locations (1)

Catawba Research, LLC; 🇺🇸 Charlotte, North Carolina, United States