At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 114 enrolled
Drug / intervention
Olumacostat Glasaretil Gel, 7.5% +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study of the Safety, Tolerability and Preliminary Efficacy of DRM01B Topical Gel in Healthy Volunteers and Subjects With Acne Vulgaris
In Brief
A Phase 2 clinical trial evaluating Olumacostat Glasaretil Gel, 7.5% and Olumacostat Glasaretil Gel, Vehicle for Acne Vulgaris. Completed, enrolled 114 participants across 12 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartAug 2013
First PostedSep 2013
Primary CompletionJun 2014
TodayJul 2026
First PostedSep 6, 2013
Enrollment StartAug 1, 2013
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.8 years ago
Interventions
Olumacostat Glasaretil Gel, 7.5%drug
Gel containing Olumacostat Glasaretil
Olumacostat Glasaretil Gel, Vehicleother
Vehicle (placebo) gel