A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
- Conditions
- Acne Vulgaris
- Interventions
- Drug: Olumacostat Glasaretil Gel, 5.0%
- Registration Number
- NCT03127956
- Lead Sponsor
- Dermira, Inc.
- Brief Summary
The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 748
- Signed informed consent or assent (for subjects under legal adult age)
- 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.
- Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator
- Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
- Primary Outcome Measures
Name Time Method Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions Day 1 - Week 36 Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (92)
Rady Children's Hospital UCSD Pediatric and Adolescent Derm
🇺🇸San Diego, California, United States
University Clinical Trials Inc.
🇺🇸San Diego, California, United States
Finlay Medical Research
🇺🇸Miami, Florida, United States
Sterling Research Group
🇺🇸Cincinnati, Ohio, United States
Burswood Dermatology
🇦🇺Victoria Park, Western Australia, Australia
Fremantle Dermatology
🇦🇺Fremantle, Western Australia, Australia
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Lynderm Research Inc.
🇨🇦Markham, Ontario, Canada
Avant Research Associates, LLC
🇺🇸Guntersville, Alabama, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Alliance Dermatology & MOHS Center
🇺🇸Phoenix, Arizona, United States
Advanced Research Associates
🇺🇸Glendale, Arizona, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Dermatology Trial Associates
🇺🇸Bryant, Arkansas, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Northwest Arkansas Clinical Trials Center
🇺🇸Rogers, Arkansas, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
TCR Medical Corporation
🇺🇸San Diego, California, United States
Radiant Research, Inc.
🇺🇸Pinellas Park, Florida, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Center for Clincial and Cosmetic Research
🇺🇸Aventura, Florida, United States
Dermatology Physicians of CT
🇺🇸Shelton, Connecticut, United States
Aby's New Generation Research Inc.
🇺🇸Hialeah, Florida, United States
Florida Academic Centers Research & Education
🇺🇸Coral Gables, Florida, United States
Floridian Research Institute
🇺🇸Miami, Florida, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Pioneer Clinical Research
🇺🇸Pembroke Pines, 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
Research Institute of the Southeast, LLC
🇺🇸West Palm Beach, Florida, United States
Visions Clinical Research
🇺🇸Wellington, Florida, United States
Marietta Dermatology Clinical Research, Inc.
🇺🇸Marietta, Georgia, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
Kansas City Dermatology, PA
🇺🇸Overland Park, Kansas, United States
Forefront Dermatology
🇺🇸Carmel, Indiana, United States
Lawrence Jeffrey Green MD, LLC
🇺🇸Rockville, Maryland, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Great Lakes Research Group, Inc
🇺🇸Bay City, Michigan, United States
Henry Ford Medical Center, New Center One
🇺🇸Detroit, Michigan, United States
Mercy Research
🇺🇸Washington, Missouri, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Meridian Clinical Research, LLC
🇺🇸Norfolk, Nebraska, United States
JDR Dermatology Research, LLC
🇺🇸Las Vegas, Nevada, United States
Schweiger Dermatology, PLLC
🇺🇸New York, New York, United States
DermResearchCenter of New York, Inc.
🇺🇸Stony Brook, New York, 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
International Clinical Research - Tennessee LLC
🇺🇸Murfreesboro, Tennessee, United States
The Skin Wellness Center
🇺🇸Knoxville, Tennessee, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Avant Research Associates
🇺🇸Beaumont, Texas, United States
Suzanne Bruce and Associates, P.A. The Center for Skin Research
🇺🇸Houston, Texas, United States
J&S Studies, Inc.
🇺🇸College Station, Texas, United States
Synexus US, LP, dba, Research Across America
🇺🇸Plano, Texas, United States
Clinical Trials of Texas, Inc.
🇺🇸San Antonio, Texas, United States
Austin Institute for Clinical Research, Inc
🇺🇸Pflugerville, Texas, United States
Progressive Clinical Research, PA
🇺🇸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
Woden Dermatology
🇦🇺Phillip, Australian Capital Territory, Australia
Premier Clinical Research
🇺🇸Spokane, Washington, United States
Premier Specialists
🇦🇺Kogarah, New South Wales, Australia
St George Dermatology and Skin Cancer Centre
🇦🇺Kogarah, New South Wales, Australia
Veracity Clinical Research
🇦🇺Woolloongabba, Queensland, Australia
Sinclair Dermatology
🇦🇺East Melbourne, Victoria, Australia
North Eastern Health Specialists
🇦🇺Hectorville, South Australia, Australia
Skin & Cancer Foundation Inc.
🇦🇺Carlton, Victoria, Australia
Enverus Medical Research
🇨🇦Surrey, British Columbia, Canada
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
SimcoDerm Medical and Surgical Dermatology Center
🇨🇦Barrie, Ontario, Canada
Institute for Skin Advancement
🇨🇦Calgary, Alberta, Canada
XLR8 Medical Research
🇨🇦Windsor, Ontario, Canada
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Research Toronto
🇨🇦Toronto, Ontario, Canada
North Bay Dermatology Centre
🇨🇦North Bay, Ontario, Canada
Windsor Research Inc.
🇨🇦Windsor, Ontario, Canada
Acne Treatment & Research Center
🇺🇸Morristown, New Jersey, United States
Advanced Skincare Surgery & MedCenter
🇺🇸Fullerton, California, United States
The Skin Centre
🇦🇺Benowa, Queensland, Australia
Northern California Research
🇺🇸Sacramento, California, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
MOORE Clinical Research, Inc
🇺🇸Tampa, Florida, United States
Skin Sciences, PLLC
🇺🇸Louisville, Kentucky, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Quality Clinical Research Inc.
🇺🇸Omaha, Nebraska, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
DermResearch, Inc
🇺🇸Austin, Texas, United States