A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

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: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Olumacostat Glasaretil Gel, 5.0%; Other: Olumacostat Glasaretil Gel, Vehicle

• Study Type: Interventional
• Enrollment (Actual): 744
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 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

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 (Actual): February 6, 2017
• Primary Completion (Actual): December 21, 2017
• Study Completion (Actual): December 21, 2017

Study Registration Dates

• First Submitted: March 3, 2017
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 8, 2017

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-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