NCT01936324

A Safety, Tolerability and Preliminary Efficacy Study of DRM01B Topical Gel

A Study of the Safety, Tolerability and Preliminary Efficacy of DRM01B Topical Gel in Healthy Volunteers and Subjects With Acne Vulgaris

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Dermira, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	Olumacostat Glasaretil Gel, 7.5%	Gel containing Olumacostat Glasaretil
OTHER	Olumacostat Glasaretil Gel, Vehicle	Vehicle (placebo) gel

Timeline

• Start date: 2013-08-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-09-06
• Last updated: 2021-07-20
• Results posted: 2019-05-10

Locations

12 sites across 1 country: Canada