A Study of the Safety, Tolerability and Preliminary Efficacy of DRM01B Topical Gel in Healthy Volunteers and Subjects With Acne Vulgaris
Overview
- Phase
- Phase 1
- Intervention
- Olumacostat Glasaretil Gel, 7.5%
- Conditions
- Acne Vulgaris
- Sponsor
- Dermira, Inc.
- Enrollment
- 114
- Locations
- 12
- Primary Endpoint
- Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Phase 1
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
Intervention: Olumacostat Glasaretil Gel, 7.5%
Phase 2a
Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Intervention: Olumacostat Glasaretil Gel, 7.5%
Phase 2a
Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Intervention: Olumacostat Glasaretil Gel, Vehicle
Outcomes
Primary Outcomes
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 in Phase 2a
Time Frame: Baseline and Week 12
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 in Phase 2a
Percentage of Subjects Who Achieved ≥ 2-grade Improvement in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 in Phase 2a
Time Frame: Baseline and Week 12
Percentage of subjects who achieved ≥ 2-grade improvement in the investigator global assessment of acne (IGA) from baseline to Week 12 in Phase 2a 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
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a
Time Frame: Baseline and Week 12
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 in Phase 2a