A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
NCT ID: NCT03127956
Last Updated: 2021-07-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
748 participants
INTERVENTIONAL
2017-03-21
2018-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Interventions
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Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.
* Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol
* Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics.
Exclusion Criteria
* Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study
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
Alliance Dermatology & MOHS Center
Phoenix, Arizona, United States
Dermatology Trial Associates
Bryant, Arkansas, United States
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, United States
Anaheim Clinical Trials
Anaheim, California, United States
Center for Dermatology Clinical Research, Inc.
Fremont, California, United States
Advanced Skincare Surgery & MedCenter
Fullerton, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Northern California Research
Sacramento, California, United States
Rady Children's Hospital UCSD Pediatric and Adolescent Derm
San Diego, California, United States
TCR Medical Corporation
San Diego, California, United States
University Clinical Trials Inc.
San Diego, California, United States
Radiant Research, Inc.
Santa Rosa, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
Dermatology Physicians of CT
Shelton, Connecticut, 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
Finlay Medical Research
Miami, 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
Health Awareness, Inc
Port Saint Lucie, Florida, United States
International Clinical Research-US, LLC
Sanford, Florida, United States
Lenus Research & Medical Group
Sweetwater, Florida, United States
MOORE Clinical Research, Inc
Tampa, Florida, United States
Visions Clinical Research
Wellington, Florida, United States
Research Institute of the Southeast, LLC
West Palm Beach, Florida, United States
Marietta Dermatology Clinical Research, Inc.
Marietta, Georgia, United States
Arlington Dermatology
Rolling Meadows, Illinois, United States
Forefront Dermatology
Carmel, Indiana, United States
Kansas City Dermatology, PA
Overland Park, Kansas, United States
Skin Sciences, PLLC
Louisville, Kentucky, United States
Clinical Trials Management, LLC
Metairie, Louisiana, United States
DelRicht Research
New Orleans, Louisiana, United States
Lawrence Jeffrey Green MD, LLC
Rockville, Maryland, United States
Great Lakes Research Group, Inc
Bay City, Michigan, United States
Henry Ford Medical Center, New Center One
Detroit, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Mercy Research
Washington, Missouri, United States
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States
Quality Clinical Research Inc.
Omaha, Nebraska, United States
Meridian Clinical Research
Omaha, Nebraska, United States
JDR Dermatology Research, LLC
Las Vegas, Nevada, United States
Acne Treatment & Research Center
Morristown, New Jersey, United States
Schweiger Dermatology, PLLC
New York, New York, United States
Skin Search of Rochester, Inc.
Rochester, New York, United States
DermResearchCenter of New York, Inc.
Stony Brook, New York, United States
Sterling Research Group
Cincinnati, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
Clinical Partners, LLC
Johnston, Rhode Island, United States
Meridian Clincial Research
Dakota Dunes, South Dakota, United States
The Skin Wellness Center
Knoxville, Tennessee, United States
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
DermResearch, Inc
Austin, Texas, United States
Avant Research Associates
Beaumont, Texas, United States
J&S Studies, Inc.
College Station, Texas, United States
Synexus US, LP, dba, Research Across America
Dallas, Texas, United States
Suzanne Bruce and Associates, P.A. The Center for Skin Research
Houston, Texas, United States
Austin Institute for Clinical Research, Inc
Pflugerville, Texas, United States
Synexus US, LP, dba, Research Across America
Plano, Texas, United States
Progressive Clinical Research, PA
San Antonio, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States
Houston Center for Clinical Research
Sugar Land, Texas, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States
Premier Clinical Research
Spokane, Washington, United States
Woden Dermatology
Phillip, Australian Capital Territory, Australia
Premier Specialists
Kogarah, New South Wales, Australia
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia
The Skin Centre
Benowa, Queensland, Australia
Veracity Clinical Research
Woolloongabba, Queensland, Australia
North Eastern Health Specialists
Hectorville, South Australia, Australia
Skin & Cancer Foundation Inc.
Carlton, Victoria, Australia
Sinclair Dermatology
East Melbourne, Victoria, Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia
Burswood Dermatology
Victoria Park, Western Australia, Australia
Institute for Skin Advancement
Calgary, Alberta, Canada
Enverus Medical Research
Surrey, British Columbia, Canada
Wiseman Dermatology Research Inc.
Winnipeg, Manitoba, Canada
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada
Lynderm Research Inc.
Markham, Ontario, Canada
DermEdge Research
Mississauga, Ontario, Canada
North Bay Dermatology Centre
North Bay, Ontario, Canada
The Centre for Dermatology
Richmond Hill, Ontario, Canada
Research Toronto
Toronto, Ontario, Canada
XLR8 Medical Research
Windsor, Ontario, Canada
Windsor Research Inc.
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-ACN05
Identifier Type: -
Identifier Source: org_study_id
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