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
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Bay City, Michigan 48706
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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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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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330 Dakota Dunes Boulevard
Dakota Dunes, South Dakota 57049
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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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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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