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

Early Phase 1

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: RETIN-A® Cream; Drug: Vehicle of the test product; Drug: Tretinoin cream 0.1%

• Registration Number: NCT03427554
• Lead Sponsor: Taro Pharmaceuticals USA

Brief 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

Study Timeline

• Study Start: 2017-08-21
• 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: 2018-02-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-16
• Last Update Posted: 2018-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 455

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).
• Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.

Exclusion Criteria

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RETIN-A® Cream	RETIN-A® Cream	Once daily at home, to apply the entire affected areas of the face.
Vehicle of the test product	Vehicle of the test product	Once daily at home, to apply the entire affected areas of the face.
Tretinoin cream 0.1%	Tretinoin cream 0.1%	Once daily at home, to apply the entire affected areas of the face.

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