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

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: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Other: Vehicle; Drug: Olumacostat Glasaretil

• Study Type: Interventional
• Enrollment (Actual): 420
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to 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	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	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; - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion; - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions); - 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; - 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

• Sponsor: Dermira, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): April 30, 2015

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: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: DRM01B-ACN02