NCT02160678

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,741 (actual)
• Sponsor: G & W Laboratories Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Vehicle	Cream Vehicle (placebo) (G \& W Laboratories, Inc.)- vehicle
DRUG	Tazarotene Cream, 0.1 %	Tazarotene Cream, 0.1 % (G \& W Laboratories, Inc.) - test product
DRUG	Tazorac Cream, 0.1%	Tazorac Cream, 0.1% (Allergan, Inc.) - reference product

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-06-11
• Last updated: 2016-11-03

Locations

1 site across 1 country: United States