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

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.
744

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
      • Benowa, Australia, 4217
        • The Skin Centre
      • Kogarah, Australia, 2217
        • Premier Specialists
      • Melbourne, Australia, 3002
        • Sinclair Dermatology
      • Victoria Park, Australia, 6100
        • Burswood Dermatology
      • Woolloongabba, Australia, 4102
        • Veracity Clinical Research
  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3V 006
        • Enverus Medical Research
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3M 3Z4
        • Wiseman Dermatology Research Inc.
    • Ontario
      • Mississauga, Ontario, Canada, L5H 1G9
        • DermEdge Research
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • The Centre for Dermatology
      • Windsor, Ontario, Canada, N8W 1E6
        • XLR8 Medical Research
  • United States
    • Alabama
      • Guntersville, Alabama, United States, 35976
        • Avant Research Associates, LLC
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Advanced Research Associates
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Dermatology Trial Associates
      • Rogers, Arkansas, United States, 72758
        • Northwest Arkansas Clinical Trials Center
    • California
      • Fremont, California, United States, 94538
        • Center For Dermatology Clinical Research, Inc.
      • Fullerton, California, United States, 92835
        • Advanced Skincare Surgery & MedCenter
      • Sacramento, California, United States, 95821
        • Northern California Research
      • San Diego, California, United States, 92123
        • TCR Medical Corporation
      • Santa Rosa, California, United States, 95405
        • Radiant Research, Inc.
    • Colorado
      • Boulder, Colorado, United States, 80301
        • Alpine Clinical Research Center
    • 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, 33145
        • Floridian Research Institute
      • Pembroke Pines, Florida, United States, 33028
        • Pioneer Clinical Research
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research, Inc.
      • Tampa, Florida, United States, 33609
        • MOORE Clinical Research, Inc
      • Wellington, Florida, United States, 44414
        • Visions Clinical Research
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Marietta Dermatology Clinical Research, Inc.
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Clinical Trials Management, LLC
      • New Orleans, Louisiana, United States, 70115
        • DelRicht Research
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center, New Center One
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • JDR Dermatology Research, LLC
    • New York
      • Rochester, New York, United States, 14623
        • Skin Search Of Rochester, Inc.
    • Ohio
      • Cincinnati, Ohio, United States, 45246
        • Sterling Research Group
    • Tennessee
      • Knoxville, Tennessee, United States, 37992
        • The Skin Wellness Center
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates, Inc.
    • Texas
      • Beaumont, Texas, United States, 77702
        • Avant Research Associates
      • 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
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research, Inc
      • Sugar Land, Texas, United States, 77479
        • Houston Center for Clinical Research
    • Virginia
      • Lynchburg, Virginia, United States, 24501
        • The Education & Research Foundation, 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

5 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

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 for 12 weeks
Drug: Olumacostat Glasaretil Gel, 5.0%
Gel containing Olumacostat Glasaretil
Other Names:
  • 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

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
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
Baseline and Week 12
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
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
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
Baseline and Week 12

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.
February 6, 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.
December 21, 2017

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.
December 21, 2017

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).
March 3, 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.
March 3, 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.
March 8, 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-ACN04

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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