A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 9 - Any |
Updated: | 2/7/2019 |
Start Date: | March 21, 2017 |
End Date: | April 27, 2018 |
An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel,
5.0% in patients with acne vulgaris
5.0% in patients with acne vulgaris
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
We found this trial at
73
sites
7810 Louis Pasteur
San Antonio, Texas 78229
San Antonio, Texas 78229
210-692-1382
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2095 Langhorne Road
Lynchburg, Virginia 24501
Lynchburg, Virginia 24501
434-847-8400
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Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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8010 Frost Street
San Diego, California 92123
San Diego, California 92123
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