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
1232
mi
from 91732
Murphy, TX
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4495 Hale Parkway
Denver, Colorado 80220
303-399-4067
820
mi
from 91732
Denver, CO
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4499 Medical Drive
San Antonio, Texas 78229
210-614-5557
1182
mi
from 91732
San Antonio, TX
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7810 Louis Pasteur
San Antonio, Texas 78229
210-692-1382
1182
mi
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San Antonio, TX
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7940 Floyd Curl Dr.
San Antonio, Texas 78229
210-949-0122
1182
mi
from 91732
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...
17
mi
from 91732
Anaheim, CA
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1100 West Central Road
Arlington Heights, Illinois 60005
1713
mi
from 91732
Arlington Heights, IL
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Austin, Texas 78759
1208
mi
from 91732
Austin, TX
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Bay City, Michigan 48706
1933
mi
from 91732
Bay City, MI
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Carmel, Indiana 46032
1793
mi
from 91732
Carmel, IN
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College Station, Texas 77845
1288
mi
from 91732
College Station, TX
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330 Dakota Dunes Boulevard
Dakota Dunes, South Dakota 57049
1299
mi
from 91732
Dakota Dunes, SD
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Fridley, Minnesota 55432
1513
mi
from 91732
Fridley, MN
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Gresham, Oregon 97030
823
mi
from 91732
Gresham, OR
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Johnston, Rhode Island 02919
2558
mi
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Johnston, RI
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Los Angeles, California 90045
23
mi
from 91732
Los Angeles, CA
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485 East Gray Street
Louisville, Kentucky 40217
1813
mi
from 91732
Louisville, KY
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Miami, Florida 33126
2316
mi
from 91732
Miami, FL
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435 South Street
Morristown, New Jersey 07960
2408
mi
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Morristown, NJ
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1035 North Highland Avenue
Murfreesboro, Tennessee 37130
1787
mi
from 91732
Murfreesboro, TN
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Murfreesboro, Tennessee 37130
1787
mi
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Murfreesboro, TN
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New York, New York 10022
2434
mi
from 91732
New York, NY
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Norfolk, Nebraska 68701
1243
mi
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Norfolk, NE
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Norfolk, Virginia 23507
2336
mi
from 91732
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...
1295
mi
from 91732
Omaha, NE
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Omaha, Nebraska 68134
1295
mi
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Omaha, NE
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Overland Park, Kansas 66215
1331
mi
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Overland Park, KS
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345
mi
from 91732
Phoenix, AZ
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1801 Southeast Hillmoor Drive
Port Saint Lucie, Florida 34952
2276
mi
from 91732
Port Saint Lucie, FL
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15005 Shady Grove Road
Rockville, Maryland 20850
2271
mi
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Rockville, MD
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8010 Frost Street
San Diego, California 92123
100
mi
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San Diego, CA
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San Diego, California 92123
105
mi
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San Diego, CA
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2183
mi
from 91732
Sanford, FL
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4 Corporate Drive
Shelton, Connecticut 06484
2476
mi
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Shelton, CT
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Stony Brook, New York 11790
2477
mi
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Stony Brook, NY
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Sweetwater, Florida 33172
2192
mi
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Sweetwater, FL
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Washington, Missouri 63090
1528
mi
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Washington, MO
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West Palm Beach, Florida 33401
2304
mi
from 91732
West Palm Beach, FL
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