NCT02411955

A Study Comparing Tazarotene Cream 0.1% to Tazorac® and Both to a Placebo Control in the Treatment of Acne Vulgaris

A Multiple-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Tazarotene Cream 0.1% to Tazorac® (Tazarotene Cream 0.1%) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1,077 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 12 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%).

Detailed description

The purpose of this study is to evaluate the therapeutic equivalence and safety of Tazarotene Cream 0.1% and Tazorac® (tazarotene cream 0.1%) in the treatment of acne vulgaris and to demonstrate the superiority of the test and reference products over the placebo control.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Tazarotene Cream 0.1%	Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
DRUG	Tazorac®	Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
DRUG	Placebo	Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2015-04-08
• Last updated: 2017-05-04