Conditions: Acne Vulgaris
Keywords: acne vulgaris
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: yes

Brief 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.

Detailed description:

Arms:
arm 1: Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers arm 2: Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks

Interventions: intervention 1: Olumacostat Glasaretil Gel, 7.5% intervention 2: Olumacostat Glasaretil Gel, Vehicle
Intervention descriptions: intervention 1: Gel containing Olumacostat Glasaretil intervention 2: Vehicle (placebo) gel

Protocol document: