A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
NCT ID: NCT02431052
Last Updated: 2021-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
420 participants
INTERVENTIONAL
2015-04-30
2016-04-30
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
TRIPLE
Study Groups
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Olumacostat Glasaretil Gel, Vehicle QD
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Vehicle
Olumacostat Glasaretil Gel, Vehicle BID
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Vehicle
Olumacostat Glasaretil Gel, 4.0% QD
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil
Olumacostat Glasaretil Gel, 7.5% QD
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil
Olumacostat Glasaretil Gel, 7.5% BID
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil
Interventions
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Olumacostat Glasaretil
Vehicle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or non-pregnant, non-lactating females.
* Age ≥ 18 years.
* Clinical diagnosis of facial acne vulgaris defined as:
* At least 20 inflammatory lesions
* At least 20 non-inflammatory lesions
* Investigator Global Assessment of 3 or greater.
Exclusion Criteria
* Two or more active nodulocystic lesions.
* Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
* Abnormal findings on screening ECG, deemed clinically significant, by the Investigator.
* 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.
* Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator.
* 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 corticosteroids (use of intranasal and inhaled corticosteroids allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline.
* Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline.
* Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g., tretinoin, tazarotene, adapalene).
* Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills.
* Prior use of androgen receptor blockers (such as spironolactone or flutamide).
* 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 of Baseline.
* Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study.
18 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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Coastal Clinical Research, Inc.
Mobile, Alabama, United States
T. Joseph Raoof, MD, Inc.
Encino, California, United States
University Clinical Trials, Inc.
San Diego, California, United States
Tory Sullivan MD PA
North Miami Beach, Florida, United States
International Clinical Research - US, LLC
Sanford, Florida, United States
MOORE Clinical Research, Inc.
Tampa, Florida, United States
Visions Clinical Research
Wellington, Florida, United States
DermResearch, PLLC
Louisville, Kentucky, United States
Lawrence J. Green, MD, LLC
Rockville, Maryland, United States
Michigan Center for Skin Care Research
Clinton Township, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Las Vegas Dermatology
Las Vegas, Nevada, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
Dermatology Consulting Services
High Point, North Carolina, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
DermResearch, Inc
Austin, Texas, United States
J&S Studies, Inc.
College Station, Texas, United States
Center for Clinical Studies, LTD. LLP
Houston, Texas, United States
Suzanne Bruce & Associates, PA. The Center for Skin Research
Houston, Texas, United States
Suzanne Bruce & Associates, PA. The Center for Skin Research
Katy, Texas, United States
Austin Institute for Clinical Research
Pflugerville, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Kirk Barber Research
Calgary, Alberta, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Lynderm Research
Markham, Ontario, Canada
Windsor Clinical Research, Inc.
Windsor, Ontario, Canada
Innovaderm Research Inc.
Montreal, Quebec, Canada
Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)
Québec, , Canada
Countries
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Other Identifiers
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DRM01B-ACN02
Identifier Type: -
Identifier Source: org_study_id
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