A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Completed · Phase 3

Conditions studied: Acne Vulgaris

In brief

The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris

Key facts

Study ID

NCT03127956

Run by

Dermira, Inc.

People needed

748

Starts

2017-03-21

Expected to finish

2018-04-27

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 or assent (for subjects under legal adult age)
• Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.
• Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol
• Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics.

You may not qualify if…

• Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator
• Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study

Where it is running

• Advanced Research Associates — Glendale, Arizona, United States
• Alliance Dermatology & MOHS Center — Phoenix, Arizona, United States
• Dermatology Trial Associates — Bryant, Arkansas, United States
• Northwest Arkansas Clinical Trials Center — Rogers, Arkansas, United States
• Anaheim Clinical Trials — Anaheim, California, United States
• Center for Dermatology Clinical Research, Inc. — Fremont, California, United States
• Advanced Skincare Surgery & MedCenter — Fullerton, California, United States
• Dermatology Research Associates — Los Angeles, California, United States
• Northern California Research — Sacramento, California, United States
• Rady Children's Hospital UCSD Pediatric and Adolescent Derm — San Diego, California, United States
• TCR Medical Corporation — San Diego, California, United States
• University Clinical Trials Inc. — San Diego, California, United States
• Radiant Research, Inc. — Santa Rosa, California, United States
• Alpine Clinical Research Center — Boulder, Colorado, United States
• Horizons Clinical Research Center, LLC — Denver, Colorado, United States
• Dermatology Physicians of CT — Shelton, Connecticut, 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
• Finlay Medical Research — Miami, 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
• Avant Research Associates, LLC — Guntersville, Alabama, United States

Full record on ClinicalTrials.gov

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