NCT00713609

Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne

A Multi-center, Randomized, Double-blind, Vehicle-Controlled, Phase 2 Study of the Safety and Efficacy of Benzoyl Peroxide/Clindamycin Gel and Tazarotene Cream When Used in Combination in the Treatment of Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 591 (actual)
• Sponsor: Stiefel, a GSK Company · Industry
• Sex: All
• Age: 12 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

Benzoyl peroxide, clindamycin and tazarotene are known to be effective treatment alternative for acne vulgaris. The purpose of this study is to assess the safety and efficacy of a combination product including these actives for the treatment of acne vulgaris. You may be suitable to take part in this study because you have acne vulgaris on your face. Acne vulgaris usually affects the face, but it can also affect the skin on the chest, arms, legs, and back.

Detailed description

The study subjects must have acne vulgaris and will apply study drug to their face for 12 weeks. Study visits will occur at baseline (day 1) and at weeks 2, 4, 8, and 12. Subjects will be assessed at every visit to determine how the study drug is working. Safety will be assessed by evaluation of adverse events (AEs), vital signs, physical examinations, and withdrawals from the study.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Benzoyl peroxide gel	5% benzoyl peroxide in a gel applied topically once a day
DRUG	Clindamycin gel	1% clindamycin phosphate applied topically once a day
DRUG	Tazarotene cream	0.1 % tazarotene in a cream applied topically once a day
DRUG	Vehicle gel	Vehicle gel is an identical gel without the active ingredients
DRUG	Vehicle cream	Vehicle cream is an identical cream without the active ingredients

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-07-11
• Last updated: 2017-03-06
• Results posted: 2017-03-06

Locations

16 sites across 1 country: United States