A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Completed · Phase 3 · Has a placebo group

Conditions studied: Acne Vulgaris

In brief

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

Key facts

Study ID

NCT03028363

Run by

Dermira, Inc.

People needed

759

Starts

2016-12-27

Expected to finish

2017-11-28

Last updated by the study team

2021-07-20

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Lenus Research & Medical Group — Sweetwater, Florida, United States
• Research Institute of the Southeast, LLC — West Palm Beach, Florida, United States
• Arlington Dermatology — Arlington Heights, Illinois, United States
• Forefront Dermatology — Carmel, Indiana, United States
• Kansas City Dermatology, PA — Overland Park, Kansas, United States
• Skin Sciences, PLLC — Louisville, Kentucky, United States
• Lawrence Jeffrey Green MD, LLC — Rockville, Maryland, United States
• Great Lakes Research Group, Inc — Bay City, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Mercy Research — Washington, Missouri, United States
• Meridian Clinical Research, LLC — Norfolk, Nebraska, United States
• Quality Clinical Research Inc — Omaha, Nebraska, United States
• Meridian Clinical Research — Omaha, Nebraska, United States
• Acne Treatment & Research Center — Morristown, New Jersey, United States
• Schweiger Dermatology, PLLC — New York, New York, United States

Full record on ClinicalTrials.gov

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