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:February 6, 2017
End Date:December 21, 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
37
sites
1900 Saint James Place
Houston, Texas 77056
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Houston, TX
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
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Boulder, CO
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
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Lynchburg, VA
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Aventura, FL
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Beaumont, Texas 77702
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Beaumont, TX
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29 Carrara Street
Benowa, 4217
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Benowa,
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3413 Lacrosse
Bryant, Arkansas 72022
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Bryant, AR
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Cincinnati, Ohio 45219
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Cincinnati, OH
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Coral Gables, FL
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9 Medical Parkway
Dallas, Texas 75234
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Dallas, TX
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Detroit, MI
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Fremont, California 94538
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Fremont, CA
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301 West Bastanchury Road
Fullerton, California 92835
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Fullerton, CA
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Glendale, Arizona 85308
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Glendale, AZ
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Guntersville, Alabama 35976
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Guntersville, AL
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Hialeah, Florida 33015
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Hialeah, FL
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Jupiter, Florida 33458
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Jupiter, FL
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Knoxville, Tennessee 37922
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Knoxville, TN
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Las Vegas, Nevada 89148
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Las Vegas, NV
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Marietta, GA
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Metairie, Louisiana 70006
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Metairie, LA
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Miami, Florida 33145
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Miami, FL
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Nashville, Tennessee 37215
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Nashville, TN
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Nashville, Tennessee 37203
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Nashville, TN
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New Orleans, Louisiana 70124
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New Orleans, LA
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Pembroke Pines, Florida 33024
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Pembroke Pines, FL
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Pflugerville, TX
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Pinellas Park, Florida 33781
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Pinellas Park, FL
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Rochester, New York 14623
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Rochester, NY
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Rogers, AR
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Sacramento, California
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Sacramento, CA
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San Diego, California 92123
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San Diego, CA
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Santa Rosa, California 95405
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Santa Rosa, CA
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Spokane, Washington 99204
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Spokane, WA
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Sugar Land, Texas 77479
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Sugar Land, TX
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Tampa, Florida 33609
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Tampa, FL
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Wellington, Florida 33414
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Wellington, FL
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