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Topical Gel

Phase 1 for Acne

Phase 1 & 2
Waitlist Available
Research Sponsored by Dermira, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 12
Awards & highlights

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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 in Phase 2a
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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase 2aExperimental Treatment2 Interventions
Olumacostat Glasaretil Gel, 7.5%, or Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Group II: Phase 1Experimental Treatment1 Intervention
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 7 days in healthy volunteers
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olumacostat glasaretil
Not yet FDA approved

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dermira, Inc.Lead Sponsor
16 Previous Clinical Trials
5,957 Total Patients Enrolled
1 Trials studying Acne
129 Patients Enrolled for Acne
Janice DrewStudy DirectorDermira, Inc.
~9 spots leftby Sep 2025
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