A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne

Phase 3 Completed 742 enrolled Stiefel, a GSK Company GlaxoSmithKline · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

Timeline

Start: 2009-10-01
Primary completion: 2010-11-01
Completion: 2010-11-09

Outcome

Met primary endpoint

registry Tazarotene Foam vs Vehicle Foam; p <0.001; ANCOVA; note: The p-value indicates treatment differences between tazarotene foam and vehicle foam for TLs NCT01017120 ↗

registry Tazarotene Foam vs Vehicle Foam; p <0.001; Percentage of participants 32.2 (95% CI 27.4 to 36.9); Cochran-Mantel-Haenszel NCT01017120 ↗

registry Tazarotene Foam vs Vehicle Foam; p <0.001; Percentage of participants 27.6 (95% CI 23.1 to 32.2); Cochran-Mantel-Haenszel NCT01017120 ↗

Publications

Background Feldman SR, Werner CP, Alio Saenz AB. The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013 Apr;12(4):438-46.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tazarotene	Small molecule	0.1 %	Topical