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
Pembroke Pines, Florida 33024
2313
mi
from 91732
Pembroke Pines, FL
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
812
mi
from 91732
Boulder, CO
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2095 Langhorne Road
Lynchburg, Virginia 24501
434-847-8400
2174
mi
from 91732
Lynchburg, VA
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2319
mi
from 91732
Aventura, FL
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Beaumont, Texas 77702
1423
mi
from 91732
Beaumont, TX
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29 Carrara Street
Benowa, 4217
7198
mi
from 91732
Benowa,
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3413 Lacrosse
Bryant, Arkansas 72022
1453
mi
from 91732
Bryant, AR
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Cincinnati, Ohio 45219
1879
mi
from 91732
Cincinnati, OH
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2318
mi
from 91732
Coral Gables, FL
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9 Medical Parkway
Dallas, Texas 75234
1218
mi
from 91732
Dallas, TX
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1965
mi
from 91732
Detroit, MI
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Fremont, California 94538
325
mi
from 91732
Fremont, CA
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301 West Bastanchury Road
Fullerton, California 92835
13
mi
from 91732
Fullerton, CA
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Glendale, Arizona 85308
335
mi
from 91732
Glendale, AZ
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Guntersville, Alabama 35976
1804
mi
from 91732
Guntersville, AL
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Hialeah, Florida 33015
2314
mi
from 91732
Hialeah, FL
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1900 Saint James Place
Houston, Texas 77056
1352
mi
from 91732
Houston, TX
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Jupiter, Florida 33458
2295
mi
from 91732
Jupiter, FL
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Knoxville, Tennessee 37922
1912
mi
from 91732
Knoxville, TN
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Las Vegas, Nevada 89148
217
mi
from 91732
Las Vegas, NV
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1908
mi
from 91732
Marietta, GA
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Metairie, Louisiana 70006
1648
mi
from 91732
Metairie, LA
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Miami, Florida 33145
2322
mi
from 91732
Miami, FL
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Nashville, Tennessee 37215
1761
mi
from 91732
Nashville, TN
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Nashville, Tennessee 37203
1762
mi
from 91732
Nashville, TN
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New Orleans, Louisiana 70124
1653
mi
from 91732
New Orleans, LA
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1215
mi
from 91732
Pflugerville, TX
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Pinellas Park, Florida 33781
2124
mi
from 91732
Pinellas Park, FL
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Rochester, New York 14623
2244
mi
from 91732
Rochester, NY
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1354
mi
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Rogers, AR
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Sacramento, California
366
mi
from 91732
Sacramento, CA
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San Diego, California 92123
106
mi
from 91732
San Diego, CA
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Santa Rosa, California 95405
397
mi
from 91732
Santa Rosa, CA
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Spokane, Washington 99204
938
mi
from 91732
Spokane, WA
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Sugar Land, Texas 77479
1347
mi
from 91732
Sugar Land, TX
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Tampa, Florida 33609
2133
mi
from 91732
Tampa, FL
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Wellington, Florida 33414
2296
mi
from 91732
Wellington, FL
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