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

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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


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
330 Dakota Dunes Boulevard
Dakota Dunes, South Dakota 57049
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
Anaheim Clinical Trials, LLC Anaheim Clinical Trials (ACT) is a research center of excellence for...
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Austin, Texas 78759
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Bay City, Michigan 48706
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Beaumont, Texas 77702
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3413 Lacrosse
Bryant, Arkansas 72022
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Carmel, Indiana 46032
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Cincinnati, Ohio 45219
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College Station, Texas 77845
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9 Medical Parkway
Dallas, Texas 75234
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Fremont, California 94538
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Fridley, Minnesota 55432
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301 West Bastanchury Road
Fullerton, California 92835
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Glendale, Arizona 85308
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Gresham, Oregon 97030
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Guntersville, Alabama 35976
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Hialeah, Florida 33015
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Johnston, Rhode Island 02919
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Jupiter, Florida 33458
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Knoxville, Tennessee 37922
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Las Vegas, Nevada 89148
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Los Angeles, California 90045
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485 East Gray Street
Louisville, Kentucky 40217
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Metairie, Louisiana 70006
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Miami, Florida 33126
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Miami, Florida 33145
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435 South Street
Morristown, New Jersey 07960
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Murfreesboro, Tennessee 37130
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Nashville, Tennessee 37203
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Nashville, Tennessee 37215
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New Orleans, Louisiana 70124
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New York, New York 10022
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Norfolk, Nebraska 68701
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Norfolk, Virginia 23507
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Omaha, Nebraska 68134
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
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Overland Park, Kansas 66215
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Pembroke Pines, Florida 33024
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Pinellas Park, Florida 33781
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1801 Southeast Hillmoor Drive
Port Saint Lucie, Florida 34952
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Rochester, New York 14623
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15005 Shady Grove Road
Rockville, Maryland 20850
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5301 Keystone Court
Rolling Meadows, Illinois 60008
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Sacramento, California
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8010 Frost Street
San Diego, California 92123
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San Diego, California 92123
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San Diego, California 92123
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Santa Rosa, California 95405
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4 Corporate Drive
Shelton, Connecticut 06484
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Spokane, Washington 99204
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Stony Brook, New York 11790
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Sugar Land, Texas 77479
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Sweetwater, Florida 33172
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Tampa, Florida 33609
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Washington, Missouri 63090
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Wellington, Florida 33414
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West Palm Beach, Florida 33401
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