drugset / Trial / NCT02431052

A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

NCT02431052 ↗

Phase 2 Completed 420 enrolled Dermira, Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.

Timeline

Start
2015-04
Primary completion
2016-04
Completion
2016-04

Outcome

Met primary endpoint

registry analysis (other test); Olumacostat Glasaretil Gel, Vehicle QD vs Olumacostat Glasaretil Gel, Vehicle BID vs Olumacostat Glasaretil Gel, 4.0% QD vs Olumacostat Glasaretil Gel, 7.5% QD vs Olumacostat Glasaretil Gel, 7.5% BID; p = 0.0006; Cochran-Mantel-Haenszel NCT02431052 ↗

registry analysis (other test); Olumacostat Glasaretil Gel, Vehicle QD vs Olumacostat Glasaretil Gel, Vehicle BID vs Olumacostat Glasaretil Gel, 4.0% QD vs Olumacostat Glasaretil Gel, 7.5% QD vs Olumacostat Glasaretil Gel, 7.5% BID; p = 0.0002; Cochran-Mantel-Haenszel NCT02431052 ↗

registry analysis (other test); Olumacostat Glasaretil Gel, Vehicle QD vs Olumacostat Glasaretil Gel, Vehicle BID vs Olumacostat Glasaretil Gel, 4.0% QD vs Olumacostat Glasaretil Gel, 7.5% QD vs Olumacostat Glasaretil Gel, 7.5% BID; p = 0.0055; Cochran-Mantel-Haenszel NCT02431052 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Olumacostat Glasaretil Small molecule 4 % Topical
Subject Olumacostat Glasaretil Small molecule 7.5 % Topical

Indications