A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel
Summary
This is a Phase 1/2a study. The purpose of Phase 1 was to evaluate the safety and tolerability of DRM01B Topical Gel in 6 healthy volunteers. The purpose of Phase 2a was to assess the safety, tolerability and preliminary efficacy of DRM01B Topical Gel compared to vehicle in subjects with acne vulgaris on the face.
Timeline
- Start
- 2013-08
- Primary completion
- 2014-06
- Completion
- 2014-06
Outcome
Met primary endpoint
registry analysis (other test); Olumacostat Glasaretil Gel, 7.5%, Phase 2a vs Olumacostat Glasaretil Gel, Vehicle, Phase 2a; p = 0.0003; ANCOVA NCT01936324 ↗
registry analysis (other test); Olumacostat Glasaretil Gel, 7.5%, Phase 2a vs Olumacostat Glasaretil Gel, Vehicle, Phase 2a; p = 0.0032; ANCOVA NCT01936324 ↗
registry analysis (other test); Olumacostat Glasaretil Gel, 7.5%, Phase 2a vs Olumacostat Glasaretil Gel, Vehicle, Phase 2a; p = 0.0070; Cochran-Mantel-Haenszel NCT01936324 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Olumacostat Glasaretil | Small molecule | 7.5 % | Topical |