Safety and Efficacy Study of Clindamycin/Benzoyl Peroxide/Tazarotene Cream in Subjects With Acne
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.
Timeline
- Start
- 2008-06
- Primary completion
- 2009-03
- Completion
- 2009-03
Outcome
Mixed primary results
registry analysis (superiority or other test); Benzoyl Peroxide/Clindamycin + Tazarotene vs Benzoyl Peroxide/Clindamycin + Vehicle Cream; p = 0.692; ANCOVA; note: For ILC NCT00713609 ↗
registry analysis (superiority or other test); Benzoyl Peroxide/Clindamycin + Tazarotene vs Benzoyl Peroxide/Clindamycin + Vehicle Cream; p <0.001; ANCOVA; note: For NILC NCT00713609 ↗
registry MEAN Benzoyl Peroxide/Clindamycin + Tazarotene: NILC, n=101, 103, 105, 105, 104, 52: -33.0 (Standard Deviation 23.94) Lesion count NCT00713609 ↗
registry MEAN Benzoyl Peroxide/Clindamycin + Vehicle Cream: NILC, n=101, 103, 105, 105, 104, 52: -24.9 (Standard Deviation 33.41) Lesion count NCT00713609 ↗
registry analysis (superiority or other test); Benzoyl Peroxide/Clindamycin + Tazarotene vs Benzoyl Peroxide/Clindamycin + Vehicle Cream; p = 0.922; Cochran-Mantel-Haenszel NCT00713609 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benzoyl Peroxide | Other / unclassified | 5 % | Topical |
| Subject | Clindamycin | Unknown | 1 % | Topical |
| Subject | Tazarotene | Small molecule | 0.1 % | Topical |