Generic Tazarotene Cream, 0.1% in the Treatment of Acne Vulgaris

Acne Vulgaris Clinical Trial

Official title: A Double-Blind,Randomized,Parallel-Group,Vehicle-Controlled,MulticenterStudy ComparingaGenericTazaroteneCream,0.1%toReference Listed Drug Tazorac® Cream, 0.1% and Both Active Treatments to Vehicle Control in the Treatment of Acne Vulgaris

Status Completed

Clinical Trial Summary

To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and to demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo) in the treatment of acne vulgaris.

Clinical Trial Description

This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of Tazarotene Cream, 0.1% in subjects with acne vulgaris. Subjects will be assigned in a 1:1:1 ratio to test product, reference product, or cream vehicle. Subjects will be admitted into the study only after written informed consent has been obtained and all of the inclusion and none of the exclusion criteria have been met. Randomized subjects will apply the study medication once daily in the evening for 12 weeks (84 days). ;

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

• NCT number: NCT02160678
• Study type: Interventional
• Source: G & W Laboratories Inc.
• Status: Completed
• Phase: Phase 3
• Start date: May 2014
• Completion date: July 2015