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

NCT03073486

Run by

Dermira, Inc.

People needed

744

Starts

2017-02-06

Expected to finish

2017-12-21

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

• Avant Research Associates, LLC — Guntersville, Alabama, United States
• Advanced Research Associates — Glendale, Arizona, United States
• Dermatology Trial Associates — Bryant, Arkansas, United States
• Northwest Arkansas Clinical Trials Center — Rogers, Arkansas, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• Advanced Skincare Surgery & MedCenter — Fullerton, California, United States
• Northern California Research — Sacramento, California, United States
• TCR Medical Corporation — San Diego, California, United States
• Radiant Research, Inc. — Santa Rosa, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Center for Clincial and Cosmetic Research — Aventura, Florida, United States
• Florida Academic Centers Research & Education — Coral Gables, Florida, United States
• Aby's New GEneration Research Inc. — Hialeah, Florida, United States
• Health Awareness, Inc. — Jupiter, Florida, United States
• Floridian Research Institute — Miami, Florida, United States
• Pioneer Clinical Research — Pembroke Pines, Florida, United States
• Radiant Research, Inc. — Pinellas Park, Florida, United States
• MOORE Clinical Research, Inc — Tampa, Florida, United States
• Visions Clinical Research — Wellington, Florida, United States
• Marietta Dermatology Clinical Research, Inc. — Marietta, Georgia, United States
• Clinical Trials Management, LLC — Metairie, Louisiana, United States
• DelRicht Research — New Orleans, Louisiana, United States
• Henry Ford Medical Center, New Center One — Detroit, Michigan, United States
• JDR Dermatology Research, LLC — Las Vegas, Nevada, United States
• Skin Search of Rochester, Inc. — Rochester, New York, United States

Full record on ClinicalTrials.gov

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