A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Phase 3

Completed

Interventions: Drug: Olumacostat Glasaretil Gel, 5.0%
Other: Olumacostat Glasaretil Gel, Vehicle

Brief 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

Recruitment & Eligibility

Inclusion Criteria

Signed informed consent and, for subjects under legal adult age, signed assent
Age ≥ 9 years
Clinical diagnosis of facial acne vulgaris defined as:
- At least 20 inflammatory lesions, and
- At least 20 non-inflammatory lesions, and
- Investigator Global Assessment of 3 or greater

Exclusion Criteria

Active cystic acne or acne conglobata, acne fulminans, and secondary acne
Two or more active nodulocystic lesions on the face
Clinically significant abnormal laboratory or ECG result
Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit
Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline
Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline
Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills).
Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline.
Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline
Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks

Arm && Interventions

Group	Intervention	Description
Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, Vehicle	Olumacostat Glasaretil Gel, Vehicle	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method

Locations (49): Alliance Dermatology & MOHS Center
🇺🇸
Phoenix, Arizona, United States
Anaheim Clinical Trials
🇺🇸
Anaheim, California, United States
Dermatology Research Associates
🇺🇸
Los Angeles, California, United States
Rady Children's Hospital UCSD Pediatric and Adolescent Derm
🇺🇸
San Diego, California, United States
University Clinical Trials Inc.
🇺🇸
San Diego, California, United States
Horizons Clinical Research Center, LLC
🇺🇸
Denver, Colorado, United States
Dermatology Physicians of CT
🇺🇸
Shelton, Connecticut, United States
Finlay Medical Research
🇺🇸
Miami, Florida, United States
Health Awareness, Inc
🇺🇸
Port Saint Lucie, Florida, United States
International Clinical Research-US, LLC
🇺🇸
Sanford, Florida, United States
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Alliance Dermatology & MOHS Center
🇺🇸Phoenix, Arizona, United States