A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
NCT ID: NCT03073486
Last Updated: 2021-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
744 participants
INTERVENTIONAL
2017-02-06
2017-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Olumacostat Glasaretil Gel, Vehicle
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, Vehicle
Vehicle (placebo) gel
Interventions
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Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Olumacostat Glasaretil Gel, Vehicle
Vehicle (placebo) gel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
9 Years
ALL
No
Sponsors
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Dermira, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Beth Zib
Role: STUDY_DIRECTOR
Dermira, Inc.
Locations
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Avant Research Associates, LLC
Guntersville, Alabama, United States
Advanced Research Associates
Glendale, Arizona, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Advanced Skincare Surgery & MedCenter
Fullerton, California, United States
Northern California Research
Sacramento, California, United States
TCR Medical Corporation
San Diego, California, United States
Radiant Research, Inc.
Santa Rosa, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Center for Clincial and Cosmetic Research
Aventura, Florida, United States
Florida Academic Centers Research & Education
Coral Gables, Florida, United States
Aby's New GEneration Research Inc.
Hialeah, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Floridian Research Institute
Miami, Florida, United States
Pioneer Clinical Research
Pembroke Pines, Florida, United States
Radiant Research, Inc.
Pinellas Park, Florida, United States
MOORE Clinical Research, Inc
Tampa, Florida, United States
Visions Clinical Research
Wellington, Florida, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Henry Ford Medical Center, New Center One
Detroit, Michigan, United States
JDR Dermatology Research, LLC
Las Vegas, Nevada, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Sterling Research Group
Cincinnati, Ohio, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Avant Research Associates
Beaumont, Texas, United States
Synexus US, LP, dba, Research Across America
Dallas, Texas, United States
Suzanne Bruce and Associates, P.A. The Center for Skin
Houston, Texas, United States
Austin Institute for Clinical Research, Inc
Pflugerville, Texas, United States
Houston Center for Clinical Research
Sugar Land, Texas, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
The Skin Centre
Benowa, , Australia
Premier Specialists
Kogarah, , Australia
Sinclair Dermatology
Melbourne, , Australia
Burswood Dermatology
Victoria Park, , Australia
Veracity Clinical Research
Woolloongabba, , Australia
Enverus Medical Research
Surrey, British Columbia, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
DermEdge Research
Mississauga, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DRM01B-ACN04
Identifier Type: -
Identifier Source: org_study_id
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