NCT02267746

A Study To Evaluate The Safety And Therapeutic Equivalence of Tazarotene Foam 0.1% in Subjects With Acne Vulgaris

A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Safety and Therapeutic Equivalence of a Generic Tazarotene Foam 0.1%(Actavis) and the Reference Listed Fabior™(Tazarotene Foam, 0.1%) (Stiefel Laboratories, Inc.) in Treatment of Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 893 (actual)
• Sponsor: Actavis Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris.

Detailed description

Although topical retinoids have been individually used to successfully treat acne vulgaris, Fabior™ (Tazarotene) Foam, 0.1% is a safe and effective topical therapy used for the treatment of acne vulgaris. Actavis has developed a generic formulation of Tazarotene Foam, 0.1%, and the current study is designed to evaluate the safety and efficacy of this formulation.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tazarotene (Fabior™)
DRUG	Tazarotene (Actavis)
DRUG	Vehicle foam

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2014-10-17
• Last updated: 2020-06-12
• Results posted: 2020-05-11

Locations

15 sites across 2 countries: United States, Belize