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
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Overland Park, Kansas 66215
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
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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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1100 West Central Road
Arlington Heights, Illinois 60005
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Austin, Texas 78759
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Bay City, Michigan 48706
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Carmel, Indiana 46032
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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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Fridley, Minnesota 55432
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Gresham, Oregon 97030
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Johnston, Rhode Island 02919
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Los Angeles, California 90045
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485 East Gray Street
Louisville, Kentucky 40217
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Miami, Florida 33126
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435 South Street
Morristown, New Jersey 07960
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1035 North Highland Avenue
Murfreesboro, Tennessee 37130
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Murfreesboro, Tennessee 37130
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Murphy, TX
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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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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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Omaha, Nebraska 68134
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Phoenix, AZ
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1801 Southeast Hillmoor Drive
Port Saint Lucie, Florida 34952
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15005 Shady Grove Road
Rockville, Maryland 20850
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8010 Frost Street
San Diego, California 92123
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San Diego, California 92123
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4 Corporate Drive
Shelton, Connecticut 06484
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Stony Brook, New York 11790
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Sweetwater, Florida 33172
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Washington, Missouri 63090
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West Palm Beach, Florida 33401
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