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A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

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ClinicalTrials.gov Identifier: NCT03028363
Recruitment Status : Completed
First Posted : January 23, 2017
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dermira, Inc.

Brief Summary:
The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Olumacostat Glasaretil Gel, 5.0% Other: Olumacostat Glasaretil Gel, Vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 759 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Actual Study Start Date : December 27, 2016
Actual Primary Completion Date : November 28, 2017
Actual Study Completion Date : November 28, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
Drug: Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Other Name: DRM01

Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Other: Olumacostat Glasaretil Gel, Vehicle
Vehicle (placebo) gel




Primary Outcome Measures :
  1. Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
    Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12

  2. Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 [ Time Frame: Baseline and Week 12 ]
    Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12

  3. 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 ]

    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

    1. - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion
    2. - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
    3. - Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion
    4. - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028363


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Locations
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United States, Arizona
Alliance Dermatology & MOHS Center
Phoenix, Arizona, United States, 85032
United States, California
Anaheim Clinical Trials
Anaheim, California, United States, 92801
Dermatology Research Associates
Los Angeles, California, United States, 90045
Rady Children's Hospital UCSD Pediatric and Adolescent Derm
San Diego, California, United States, 92123
University Clinical Trials Inc.
San Diego, California, United States, 92123
United States, Colorado
Horizons Clinical Research Center, LLC
Denver, Colorado, United States, 80220
United States, Connecticut
Dermatology Physicians of CT
Shelton, Connecticut, United States, 06484
United States, Florida
Finlay Medical Research
Miami, Florida, United States, 33126
Health Awareness, Inc
Port Saint Lucie, Florida, United States, 34952
International Clinical Research-US, LLC
Sanford, Florida, United States, 32771
Lenus Research & Medical Group
Sweetwater, Florida, United States, 33172
Research Institute of the Southeast, LLC
West Palm Beach, Florida, United States, 33401
United States, Illinois
Arlington Dermatology
Arlington Heights, Illinois, United States, 60005
United States, Indiana
Forefront Dermatology
Carmel, Indiana, United States, 46032
United States, Kansas
Kansas City Dermatology, PA
Overland Park, Kansas, United States, 66215
United States, Kentucky
Skin Sciences, PLLC
Louisville, Kentucky, United States, 40217
United States, Maryland
Lawrence Jeffrey Green MD, LLC
Rockville, Maryland, United States, 20850
United States, Michigan
Great Lakes Research Group, Inc
Bay City, Michigan, United States, 48706
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Missouri
Mercy Research
Washington, Missouri, United States, 63090
United States, Nebraska
Meridian Clinical Research, LLC
Norfolk, Nebraska, United States, 68701
Quality Clinical Research Inc
Omaha, Nebraska, United States, 68114
Meridian Clinical Research
Omaha, Nebraska, United States, 68134
United States, New Jersey
Acne Treatment & Research Center
Morristown, New Jersey, United States, 07960
United States, New York
Schweiger Dermatology, PLLC
New York, New York, United States, 10022
DermResearchCenter of New York, Inc.
Stony Brook, New York, United States, 11790
United States, Oregon
Cyn3rgy Research
Gresham, Oregon, United States, 97030
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, South Dakota
Meridian Clincial Research
Dakota Dunes, South Dakota, United States, 57049
United States, Tennessee
International Clinical Research - Tennessee LLC
Murfreesboro, Tennessee, United States, 37130
International Clinical Research-Tennesse LLC
Murfreesboro, Tennessee, United States, 37130
United States, Texas
DermResearch
Austin, Texas, United States, 78759
J &S Studies, Inc
College Station, Texas, United States, 77845
Synexus US, LP, dba, Research Across America
Murphy, Texas, United States, 75094
Progressive Clinical Research, PA
San Antonio, Texas, United States, 78213
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Dermatology Clinical Research Center of San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Australia, Australian Capital Territory
Woden Dermatology
Phillip, Australian Capital Territory, Australia, 2606
Australia, New South Wales
St George Dermatology and Skin Cancer Centre
Kogarah, New South Wales, Australia, 2217
Australia, South Australia
North Eastern Health Specialists
Hectorville, South Australia, Australia, 5073
Australia, Victoria
Skin & Cancer Foundation Inc.
Carlton, Victoria, Australia, 3053
Australia, Western Australia
Fremantle Dermatology
Fremantle, Western Australia, Australia, 6160
Canada, Alberta
Institute for Skin Advancement
Calgary, Alberta, Canada, T3A 2N1
Canada, Ontario
SimcoDerm Medical and Surgical Dermatology Center
Barrie, Ontario, Canada, L4M 7G1
Lynderm Research Inc.
Markham, Ontario, Canada, L3P 1X2
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B 3Z7
Research Toronto
Toronto, Ontario, Canada, M4W 2N2
Windsor Research Inc.
Windsor, Ontario, Canada, N8W 5L7
Sponsors and Collaborators
Dermira, Inc.
Investigators
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Study Director: Beth Zib Dermira, Inc.
  Study Documents (Full-Text)

Documents provided by Dermira, Inc.:
Study Protocol  [PDF] October 6, 2016
Statistical Analysis Plan  [PDF] January 19, 2018


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Responsible Party: Dermira, Inc.
ClinicalTrials.gov Identifier: NCT03028363     History of Changes
Other Study ID Numbers: DRM01B-ACN03
First Posted: January 23, 2017    Key Record Dates
Results First Posted: February 5, 2019
Last Update Posted: February 5, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases