A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

July 16, 2021 updated by: Dermira, Inc.

An Open-Label Study Assessing Long-Term Safety of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
748

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • Australian Capital Territory
      • Phillip, Australian Capital Territory, Australia, 2606
        • Woden Dermatology
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • St George Dermatology and Skin Cancer Centre
      • Kogarah, New South Wales, Australia, 2217
        • Premier Specialists
    • Queensland
      • Benowa, Queensland, Australia, 4217
        • The Skin Centre
      • Woolloongabba, Queensland, Australia, 4102
        • Veracity Clinical Research
    • South Australia
      • Hectorville, South Australia, Australia, 5073
        • North Eastern Health Specialists
    • Victoria
      • Carlton, Victoria, Australia, 3053
        • Skin & Cancer Foundation Inc.
      • East Melbourne, Victoria, Australia, 3002
        • Sinclair Dermatology
    • Western Australia
      • Fremantle, Western Australia, Australia, 6160
        • Fremantle Dermatology
      • Victoria Park, Western Australia, Australia, 6100
        • Burswood Dermatology
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3A 2N1
        • Institute For Skin Advancement
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 0C6
        • Enverus Medical Research
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • Barrie, Ontario, Canada, L4M 7G1
        • SimcoDerm Medical and Surgical Dermatology Center
      • Markham, Ontario, Canada, L3P 1X2
        • Lynderm Research Inc.
      • Mississauga, Ontario, Canada, L5H 1G9
        • DermEdge Research
      • North Bay, Ontario, Canada, P1B 3Z7
        • North Bay Dermatology Centre
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • The Centre For Dermatology
      • Toronto, Ontario, Canada, M4W 2N2
        • Research Toronto
      • Windsor, Ontario, Canada, N8W 1E6
        • XLR8 Medical Research
      • Windsor, Ontario, Canada, N8W 5L7
        • Windsor Research Inc.
  • United States
    • Alabama
      • Guntersville, Alabama, United States, 35976
        • Avant Research Associates, LLC
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Advanced Research Associates
      • Phoenix, Arizona, United States, 85032
        • Alliance Dermatology & Mohs Center
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermatology Trial Associates
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
      • Fullerton, California, United States, 92835
        • Advanced Skincare Surgery & MedCenter
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Sacramento, California, United States, 95821
        • Northern California Research
      • San Diego, California, United States, 92123
        • TCR Medical Corporation
      • San Diego, California, United States, 92123
        • Rady Children's Hospital UCSD Pediatric and Adolescent Derm
      • San Diego, California, United States, 92123
        • University Clinical Trials Inc.
      • Santa Rosa, California, United States, 95405
        • Radiant Research, Inc.
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Alpine Clinical Research Center
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center, LLC
    • Connecticut
      • Shelton, Connecticut, United States, 06484
        • Dermatology Physicians of CT
    • Florida
      • Aventura, Florida, United States, 33180
        • Center for Clincial and Cosmetic Research
      • Coral Gables, Florida, United States, 33134
        • Florida Academic Centers Research & Education
      • Hialeah, Florida, United States, 33015
        • Aby's New Generation Research Inc.
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Miami, Florida, United States, 33126
        • Finlay Medical Research
      • Miami, Florida, United States, 33145
        • Floridian Research Institute
      • Pembroke Pines, Florida, United States, 33028
        • Pioneer Clinical Research
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research, Inc.
      • Port Saint Lucie, Florida, United States, 34952
        • Health Awareness, Inc
      • Sanford, Florida, United States, 32771
        • International Clinical Research-US, LLC
      • Sweetwater, Florida, United States, 33172
        • Lenus Research & Medical Group
      • Tampa, Florida, United States, 33609
        • MOORE Clinical Research, Inc
      • Wellington, Florida, United States, 33414
        • Visions Clinical Research
      • West Palm Beach, Florida, United States, 33401
        • Research Institute of the Southeast, Llc
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Dermatology Clinical Research, Inc.
    • Illinois
      • Rolling Meadows, Illinois, United States, 60008
        • Arlington Dermatology
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Forefront Dermatology
    • Kansas
      • Overland Park, Kansas, United States, 66215
        • Kansas City Dermatology, PA
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Skin Sciences, PLLC
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management, LLC
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence Jeffrey Green MD, LLC
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center, New Center One
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • Missouri
      • Washington, Missouri, United States, 63090
        • Mercy Research
    • Nebraska
      • Norfolk, Nebraska, United States, 68701
        • Meridian Clinical Research, LLC
      • Omaha, Nebraska, United States, 68134
        • Meridian Clinical Research
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research Inc.
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • JDR Dermatology Research, LLC
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Acne Treatment & Research Center
    • New York
      • New York, New York, United States, 10022
        • Schweiger Dermatology, PLLC
      • Rochester, New York, United States, 14623
        • Skin Search of Rochester, Inc.
      • Stony Brook, New York, United States, 11790
        • DermResearchCenter of New York, Inc.
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Sterling Research Group
    • Oregon
      • Gresham, Oregon, United States, 97030
        • Cyn3rgy Research
    • Rhode Island
      • Johnston, Rhode Island, United States, 02919
        • Clinical Partners, LLC
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Meridian Clincial Research
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • The Skin Wellness Center
      • Murfreesboro, Tennessee, United States, 37130
        • International Clinical Research - Tennessee LLC
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch, Inc
      • Beaumont, Texas, United States, 77702
        • Avant Research Associates
      • College Station, Texas, United States, 77845
        • J&S Studies, Inc.
      • Dallas, Texas, United States, 75234
        • Synexus US, LP, dba, Research Across America
      • Houston, Texas, United States, 77056
        • Suzanne Bruce and Associates, P.A. The Center for Skin Research
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research, Inc
      • Plano, Texas, United States, 75093
        • Synexus US, LP, dba, Research Across America
      • San Antonio, Texas, United States, 78213
        • Progressive Clinical Research, PA
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • Sugar Land, Texas, United States, 77479
        • Houston Center for Clinical Research
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Education & Research Foundation, Inc.
      • Norfolk, Virginia, United States, 23502
        • Virginia Clinical Research, Inc.
    • Washington
      • Spokane, Washington, United States, 99202
        • Premier Clinical Research

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 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.

Exclusion Criteria:

  • 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 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face
Drug: Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Other Names:
  • DRM01B

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Time Frame: Day 1 - Week 36
Long-Term Safety Assessed Through Adverse Events and Local Skin Reactions
Day 1 - Week 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dermira, Inc.

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DRM01B-ACN05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

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