A 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:December 27, 2016
End Date:November 28, 2017

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A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil
Gel compared to vehicle in patients with acne vulgaris


Inclusion Criteria:

- Signed informed consent and, for subjects under legal adult age, signed assent

- Age ≥ 9 years

- Clinical diagnosis of facial acne vulgaris defined as:

- At least 20 inflammatory lesions, and

- At least 20 non-inflammatory lesions, and

- Investigator Global Assessment of 3 or greater

Exclusion Criteria:

- Active cystic acne or acne conglobata, acne fulminans, and secondary acne

- Two or more active nodulocystic lesions on the face

- Clinically significant abnormal laboratory or ECG result

- Subjects who are actively participating in an experimental therapy study or who have
received experimental therapy within 30 days or 5 half-lives (whichever is longer) of
the Baseline visit

- Treatment with over-the-counter topical medications for the treatment of acne vulgaris
including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids,
α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline

- Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid
within 4 weeks prior to Baseline

- Treatment with a new hormonal therapy or dose change to existing hormonal therapy
within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to,
estrogenic and progestational agents such as birth control pills).

- Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks
prior to Baseline.

- Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A
supplements greater than 10,000 units/day within 6 months prior to Baseline

- Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8
weeks
We found this trial at
38
sites
8010 Frost Street
San Diego, California 92123
1948
mi
from 43215
San Diego, CA
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
1159
mi
from 43215
Denver, CO
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
1137
mi
from 43215
San Antonio, TX
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
1137
mi
from 43215
San Antonio, TX
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1137
mi
from 43215
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
from 43215
Anaheim, CA
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1100 West Central Road
Arlington Heights, Illinois 60005
297
mi
from 43215
Arlington Heights, IL
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Austin, Texas 78759
1059
mi
from 43215
Austin, TX
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Bay City, Michigan 48706
255
mi
from 43215
Bay City, MI
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Carmel, Indiana 46032
166
mi
from 43215
Carmel, IN
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College Station, Texas 77845
988
mi
from 43215
College Station, TX
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330 Dakota Dunes Boulevard
Dakota Dunes, South Dakota 57049
720
mi
from 43215
Dakota Dunes, SD
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Fridley, Minnesota 55432
629
mi
from 43215
Fridley, MN
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Gresham, Oregon 97030
2015
mi
from 43215
Gresham, OR
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Johnston, Rhode Island 02919
614
mi
from 43215
Johnston, RI
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Los Angeles, California 90045
1982
mi
from 43215
Los Angeles, CA
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485 East Gray Street
Louisville, Kentucky 40217
188
mi
from 43215
Louisville, KY
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Miami, Florida 33126
992
mi
from 43215
Miami, FL
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435 South Street
Morristown, New Jersey 07960
453
mi
from 43215
Morristown, NJ
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1035 North Highland Avenue
Murfreesboro, Tennessee 37130
337
mi
from 43215
Murfreesboro, TN
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Murfreesboro, Tennessee 37130
338
mi
from 43215
Murfreesboro, TN
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893
mi
from 43215
Murphy, TX
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New York, New York 10022
479
mi
from 43215
New York, NY
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Norfolk, Nebraska 68701
762
mi
from 43215
Norfolk, NE
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Norfolk, Virginia 23507
422
mi
from 43215
Norfolk, VA
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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
mi
from 43215
Omaha, NE
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Omaha, Nebraska 68134
688
mi
from 43215
Omaha, NE
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Overland Park, Kansas 66215
628
mi
from 43215
Overland Park, KS
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1654
mi
from 43215
Phoenix, AZ
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1801 Southeast Hillmoor Drive
Port Saint Lucie, Florida 34952
889
mi
from 43215
Port Saint Lucie, FL
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15005 Shady Grove Road
Rockville, Maryland 20850
316
mi
from 43215
Rockville, MD
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San Diego, California 92123
1951
mi
from 43215
San Diego, CA
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777
mi
from 43215
Sanford, FL
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4 Corporate Drive
Shelton, Connecticut 06484
526
mi
from 43215
Shelton, CT
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Stony Brook, New York 11790
524
mi
from 43215
Stony Brook, NY
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Sweetwater, Florida 33172
870
mi
from 43215
Sweetwater, FL
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Washington, Missouri 63090
438
mi
from 43215
Washington, MO
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West Palm Beach, Florida 33401
931
mi
from 43215
West Palm Beach, FL
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