Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects
Summary
This is a multicenter, randomized, single-blinded (investigator's blinded), active-controlled (clindamycin \[CLDM\] 1% gel), parallel-group study in Japanese subjects with acne vulgaris to demonstrate the efficacy of GSK2585823 (CLDM 1%-benzoyl peroxide \[BPO\] 3% gel) when applied once or twice daily for 12 weeks. This study will also evaluate the safety of GSK2585823 when applied topically either once or twice daily for 12 weeks.
Timeline
- Start
- 2011-09-27
- Primary completion
- 2012-08-02
- Completion
- 2012-08-02
Outcome
Met primary endpoint
registry analysis (superiority or other test); GSK2585823 Twice Daily vs CLDM Twice Daily; p <0.001; Mean Difference (Net) -11.0 (95% CI -15.0 to -7.0); ANCOVA NCT01445301 ↗
registry analysis (non-inferiority test); GSK2585823 Once Daily vs CLDM Twice Daily; p <0.001; Mean Difference (Net) -8.2 (95% CI -12.9 to -3.6); ANCOVA NCT01445301 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benzoyl Peroxide | Other / unclassified | 30 mg | Topical |
| Subject | Clindamycin | Unknown | 10 mg | Topical |