A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

July 16, 2021 updated by: Dermira, Inc.

A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris

The objectives of this study are to assess the safety and efficacy DRM01 Topical 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.
420

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 2

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

  • Canada
      • Quebec, Canada, G1V 4X7
        • Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)
    • Alberta
      • Calgary, Alberta, Canada, T2G1B1
        • Kirk Barber Research
    • British Columbia
      • Surrey, British Columbia, Canada, V3V0C6
        • Enverus Medical Research
    • Ontario
      • Markham, Ontario, Canada, L3P1X2
        • Lynderm Research
      • Windsor, Ontario, Canada, N8W 5L7
        • Windsor Clinical Research, Inc.
    • Quebec
      • Montreal, Quebec, Canada, H2K 4L5
        • Innovaderm Research Inc.
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
    • California
      • Encino, California, United States, 94136
        • T. Joseph Raoof, MD, Inc.
      • San Diego, California, United States, 92123
        • University Clinical Trials, Inc.
    • Florida
      • North Miami Beach, Florida, United States, 33162
        • Tory Sullivan MD PA
      • Sanford, Florida, United States, 32771
        • International Clinical Research - US, LLC
      • Tampa, Florida, United States, 33609
        • MOORE Clinical Research, Inc.
      • Wellington, Florida, United States, 33414
        • Visions Clinical Research
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • DermResearch, PLLC
    • Maryland
      • Rockville, Maryland, United States, 20850
        • Lawrence J. Green, MD, LLC
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Michigan Center for Skin Care Research
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Las Vegas Dermatology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • New York
      • Rochester, New York, United States, 14623
        • Skin Search Of Rochester, Inc.
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Dermatology Consulting Services
    • Tennessee
      • Knoxville, Tennessee, United States, 37922
        • The Skin Wellness Center
      • Murfreesboro, Tennessee, United States, 37130
        • International Clinical Research - Tennessee LLC
    • Texas
      • Austin, Texas, United States, 78759
        • DermResearch, Inc
      • College Station, Texas, United States, 77845
        • J&S Studies, Inc.
      • Houston, Texas, United States, 77004
        • Center for Clinical Studies, LTD. LLP
      • Houston, Texas, United States, 77056
        • Suzanne Bruce & Associates, PA. The Center for Skin Research
      • Katy, Texas, United States, 77494
        • Suzanne Bruce & Associates, PA. The Center for Skin Research
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research, PA
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Dermatology Research Center, Inc.
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed informed consent.
  • Male or non-pregnant, non-lactating females.
  • Age ≥ 18 years.
  • Clinical diagnosis of facial acne vulgaris defined as:
  • At least 20 inflammatory lesions
  • At least 20 non-inflammatory lesions
  • 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.
  • Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator.
  • Abnormal findings on screening ECG, deemed clinically significant, by the Investigator.
  • 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.
  • Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator.
  • 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 corticosteroids (use of intranasal and inhaled corticosteroids allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline.
  • Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline.
  • Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g., tretinoin, tazarotene, adapalene).
  • Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills.
  • Prior use of androgen receptor blockers (such as spironolactone or flutamide).
  • 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 of Baseline.
  • Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

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.
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle QD
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Other: Vehicle
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle BID
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Other: Vehicle
Experimental: Olumacostat Glasaretil Gel, 4.0% QD
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Drug: Olumacostat Glasaretil
Other Names:
  • DRM01B
Experimental: Olumacostat Glasaretil Gel, 7.5% QD
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Drug: Olumacostat Glasaretil
Other Names:
  • DRM01B
Experimental: Olumacostat Glasaretil Gel, 7.5% BID
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Drug: 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
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

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.
April 1, 2015

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 1, 2016

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 1, 2016

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 27, 2015

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 29, 2015

First Posted (Estimate)

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 30, 2015

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-ACN02

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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