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A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris
The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.
Details
| Lead sponsor | Dermira, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 420 |
| Start date | 2015-04 |
| Completion | 2016-04 |
Conditions
- Acne Vulgaris
Interventions
- Olumacostat Glasaretil
- Vehicle
Primary outcomes
- Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 — Baseline and Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 - Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 — Baseline and Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 - Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 — Baseline and Week 12
Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions 1. \- Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion 2. \- Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. \- Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion 4. \- Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions
Countries
United States, Canada