- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03028363
A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
July 16, 2021 updated by: Dermira, Inc.
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
759
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Australian Capital Territory
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Phillip, Australian Capital Territory, Australia, 2606
- Woden Dermatology
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New South Wales
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Kogarah, New South Wales, Australia, 2217
- St George Dermatology and Skin Cancer Centre
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South Australia
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Hectorville, South Australia, Australia, 5073
- North Eastern Health Specialists
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Victoria
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Carlton, Victoria, Australia, 3053
- Skin & Cancer Foundation Inc.
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Western Australia
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Fremantle, Western Australia, Australia, 6160
- Fremantle Dermatology
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Alberta
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Calgary, Alberta, Canada, T3A 2N1
- Institute for Skin Advancement
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Ontario
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Barrie, Ontario, Canada, L4M 7G1
- SimcoDerm Medical and Surgical Dermatology Center
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Markham, Ontario, Canada, L3P 1X2
- Lynderm Research Inc.
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North Bay, Ontario, Canada, P1B 3Z7
- North Bay Dermatology Centre
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Toronto, Ontario, Canada, M4W 2N2
- Research Toronto
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Windsor, Ontario, Canada, N8W 5L7
- Windsor Research Inc.
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Arizona
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Phoenix, Arizona, United States, 85032
- Alliance Dermatology & MOHS Center
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California
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Anaheim, California, United States, 92801
- Anaheim Clinical Trials
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Los Angeles, California, United States, 90045
- Dermatology Research Associates
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San Diego, California, United States, 92123
- Rady Children's Hospital UCSD Pediatric and Adolescent Derm
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San Diego, California, United States, 92123
- University Clinical Trials Inc.
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Colorado
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Denver, Colorado, United States, 80220
- Horizons Clinical Research Center, LLC
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Connecticut
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Shelton, Connecticut, United States, 06484
- Dermatology Physicians of CT
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Florida
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Miami, Florida, United States, 33126
- Finlay Medical Research
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Port Saint Lucie, Florida, United States, 34952
- Health Awareness, Inc
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Sanford, Florida, United States, 32771
- International Clinical Research-US, LLC
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Sweetwater, Florida, United States, 33172
- Lenus Research & Medical Group
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West Palm Beach, Florida, United States, 33401
- Research Institute of the southeast, LLC
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Illinois
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Arlington Heights, Illinois, United States, 60005
- Arlington Dermatology
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Indiana
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Carmel, Indiana, United States, 46032
- Forefront Dermatology
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Kansas
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Overland Park, Kansas, United States, 66215
- Kansas City Dermatology, PA
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Kentucky
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Louisville, Kentucky, United States, 40217
- Skin Sciences, PLLC
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Maryland
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Rockville, Maryland, United States, 20850
- Lawrence Jeffrey Green MD, LLC
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Michigan
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Bay City, Michigan, United States, 48706
- Great Lakes Research Group, Inc
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Minnesota
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Fridley, Minnesota, United States, 55432
- Minnesota Clinical Study Center
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Missouri
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Washington, Missouri, United States, 63090
- Mercy Research
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Nebraska
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Norfolk, Nebraska, United States, 68701
- Meridian Clinical Research, LLC
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Omaha, Nebraska, United States, 68134
- Meridian Clinical Research
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Omaha, Nebraska, United States, 68114
- Quality Clinical Research Inc
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New Jersey
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Morristown, New Jersey, United States, 07960
- Acne Treatment & Research Center
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New York
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New York, New York, United States, 10022
- Schweiger Dermatology, PLLC
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Stony Brook, New York, United States, 11790
- DermResearchCenter of New York, Inc.
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Oregon
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Gresham, Oregon, United States, 97030
- Cyn3rgy Research
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Rhode Island
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Johnston, Rhode Island, United States, 02919
- Clinical Partners, LLC
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South Dakota
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Dakota Dunes, South Dakota, United States, 57049
- Meridian Clincial Research
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Tennessee
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Murfreesboro, Tennessee, United States, 37130
- International Clinical Research - Tennessee LLC
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Murfreesboro, Tennessee, United States, 37130
- International Clinical Research-Tennesse LLC
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Texas
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Austin, Texas, United States, 78759
- DermResearch
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College Station, Texas, United States, 77845
- J &S Studies, Inc
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Murphy, Texas, United States, 75094
- Synexus US, LP, dba, Research Across America
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San Antonio, Texas, United States, 78213
- Progressive Clinical Research, PA
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San Antonio, Texas, United States, 78229
- Dermatology Clinical Research Center of San Antonio
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San Antonio, Texas, United States, 78229
- Clinical Trials of Texas, Inc.
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Virginia
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Norfolk, Virginia, United States, 23507
- Virginia Clinical Research, Inc.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
9 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Gel containing Olumacostat Glasaretil
Other Names:
|
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
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Vehicle (placebo) gel
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Time Frame: Baseline and Week 12
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Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
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Baseline and Week 12
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Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Time Frame: Baseline and Week 12
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Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
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Baseline and Week 12
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Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12
Time Frame: Baseline and Week 12
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Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions
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Baseline and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 27, 2016
Primary Completion (Actual)
November 28, 2017
Study Completion (Actual)
November 28, 2017
Study Registration Dates
First Submitted
January 19, 2017
First Submitted That Met QC Criteria
January 19, 2017
First Posted (Estimate)
January 23, 2017
Study Record Updates
Last Update Posted (Actual)
July 20, 2021
Last Update Submitted That Met QC Criteria
July 16, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DRM01B-ACN03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acne Vulgaris
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Galderma R&DCompletedSevere Acne VulgarisUnited States, Canada, Puerto Rico
-
Sebacia, Inc.CompletedInflammatory Acne VulgarisUnited States
-
Nexgen Dermatologics, Inc.Unknown
-
InMode MD Ltd.Active, not recruitingInflammatory Acne VulgarisUnited States
-
PollogenLumenis Be Ltd.Not yet recruitingModerate to Severe Acne Vulgaris
-
Boston PharmaceuticalsCompletedModerate to Severe Acne VulgarisUnited States, Canada
-
Bispebjerg HospitalCompleted
-
Actavis Mid-Atlantic LLCCompletedMILD TO SEVERE ACNE VULGARISIndia
-
Assiut UniversityCompleted
-
Zagazig UniversityCompletedAcne Vulgaris Superficial Mixed Comedonal and InflammatoryEgypt
Clinical Trials on Olumacostat Glasaretil Gel, 5.0%
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Dermira, Inc.CompletedAcne VulgarisUnited States, Canada, Australia
-
Dermira, Inc.CompletedAcne VulgarisUnited States, Canada, Australia
-
Dermira, Inc.Completed
-
Dermira, Inc.Completed
-
PfizerCompletedAdvanced Multiple MyelomaGermany, United States, Spain, United Kingdom, Belgium, Canada, France, Greece
-
Seegpharm S.A.Completed
-
University of WashingtonNational Institutes of Health (NIH); National Institute on Aging (NIA)CompletedHealthyUnited States