At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 759 enrolled
Drug / intervention
Olumacostat Glasaretil Gel, 5.0% +1 moredrug
Likely dose
Olumacostat Glasaretil Gel 5.0%AI-extracted
Key inclusion· 4
- ✓Age 9 years or older
- ✓Facial acne vulgaris with at least 20 inflammatory lesions and at least 20 non-inflammatory lesions
- ✓Investigator Global Assessment score of 3 or greater
- ✓Signed informed consent (and assent if under legal adult age)
Key exclusion· 10
- ✕Active cystic acne, acne conglobata, acne fulminans, or secondary acne
- ✕Two or more active nodulocystic lesions on the face
- ✕Clinically significant abnormal laboratory or ECG result
- ✕Recent participation in experimental therapy study or receipt of experimental therapy within 30 days or 5 half-lives (whichever is longer)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
In Brief
A Phase 3 clinical trial evaluating Olumacostat Glasaretil Gel, 5.0% and Olumacostat Glasaretil Gel, Vehicle for Acne Vulgaris. Completed, enrolled 759 participants across 49 sites in 3 countries.
Detailed Summary
The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Vulgaris
CountriesAustralia, Canada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartDec 2016
First PostedJan 2017
Primary CompletionNov 2017
TodayJul 2026
First PostedJan 23, 2017
Enrollment StartDec 27, 2016
Primary CompletionNov 28, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 9.4 years ago
Interventions
Olumacostat Glasaretil Gel, 5.0%drug
Gel containing Olumacostat Glasaretil
Olumacostat Glasaretil Gel, Vehicleother
Vehicle (placebo) gel