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
Nashville, Tennessee 37215
337
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Nashville, TN
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
1175
mi
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Boulder, CO
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
1159
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Denver, CO
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
272
mi
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Lynchburg, VA
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
1137
mi
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San Antonio, TX
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1137
mi
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San Antonio, TX
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
1137
mi
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San Antonio, TX
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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...
1960
mi
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Anaheim, CA
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Austin, Texas 78759
1059
mi
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Austin, TX
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981
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Aventura, FL
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Bay City, Michigan 48706
255
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Bay City, MI
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Beaumont, Texas 77702
925
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Beaumont, TX
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3413 Lacrosse
Bryant, Arkansas 72022
636
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Bryant, AR
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Carmel, Indiana 46032
166
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Carmel, IN
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Cincinnati, Ohio 45219
98
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Cincinnati, OH
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College Station, Texas 77845
988
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College Station, TX
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994
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Coral Gables, FL
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330 Dakota Dunes Boulevard
Dakota Dunes, South Dakota 57049
720
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Dakota Dunes, SD
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9 Medical Parkway
Dallas, Texas 75234
909
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166
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Detroit, MI
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Fremont, California 94538
2088
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Fremont, CA
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Fridley, Minnesota 55432
629
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Fridley, MN
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301 West Bastanchury Road
Fullerton, California 92835
1959
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Fullerton, CA
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Glendale, Arizona 85308
1662
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Glendale, AZ
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Gresham, Oregon 97030
2015
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Gresham, OR
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Guntersville, Alabama 35976
427
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Hialeah, Florida 33015
987
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Hialeah, FL
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996
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Houston, TX
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Johnston, Rhode Island 02919
614
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Johnston, RI
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Jupiter, Florida 33458
916
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Jupiter, FL
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Knoxville, Tennessee 37922
288
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Knoxville, TN
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Las Vegas, Nevada 89148
1756
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Las Vegas, NV
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Los Angeles, California 90045
1982
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485 East Gray Street
Louisville, Kentucky 40217
188
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Louisville, KY
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423
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Marietta, GA
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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
453
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Murfreesboro, Tennessee 37130
338
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Nashville, Tennessee 37203
333
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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
688
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Omaha, NE
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
688
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Omaha, NE
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Overland Park, Kansas 66215
628
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Pembroke Pines, Florida 33024
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1052
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Pflugerville, TX
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1654
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Phoenix, AZ
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Pinellas Park, Florida 33781
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Plano, TX
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1801 Southeast Hillmoor Drive
Port Saint Lucie, Florida 34952
889
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Port Saint Lucie, FL
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Rochester, New York 14623
352
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15005 Shady Grove Road
Rockville, Maryland 20850
316
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652
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Rogers, AR
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5301 Keystone Court
Rolling Meadows, Illinois 60008
297
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Rolling Meadows, IL
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Sacramento, California
2043
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8010 Frost Street
San Diego, California 92123
1948
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San Diego, California 92123
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San Diego, California 92123
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Sanford, FL
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Santa Rosa, California 95405
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4 Corporate Drive
Shelton, Connecticut 06484
526
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Spokane, Washington 99204
1779
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Stony Brook, New York 11790
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Sugar Land, Texas 77479
1010
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Sweetwater, Florida 33172
870
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Tampa, Florida 33609
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Washington, Missouri 63090
438
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Wellington, Florida 33414
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West Palm Beach, Florida 33401
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