A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Phase 3

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Olumacostat Glasaretil Gel, 5.0%; Other: Olumacostat Glasaretil Gel, Vehicle

• Registration Number: NCT03028363
• Lead Sponsor: Dermira, Inc.

Brief Summary

The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-27
• Study First Submitted: 2017-01-19
• Study First Submitted QC: 2017-01-19
• Study First Posted: 2017-01-23
• Primary Completion: 2017-11-28
• Study Completion: 2017-11-28
• Results First Submitted: 2018-11-28
• Results First Submitted QC: 2019-02-01
• Results First Posted: 2019-02-05
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-16
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 759

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, Vehicle	Olumacostat Glasaretil Gel, Vehicle	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks

Primary Outcome Measures

Name	Time	Method
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12	Baseline and Week 12	Mean absolute change in acne lesion counts (inflammatory) 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	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
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12	Baseline and Week 12	Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12

Trial Locations

Locations (49)

Research Institute of the Southeast, LLC; 🇺🇸 West Palm Beach, Florida, United States

Rady Children's Hospital UCSD Pediatric and Adolescent Derm; 🇺🇸 San Diego, California, United States

University Clinical Trials Inc.; 🇺🇸 San Diego, California, United States

Clinical Trials of Texas, Inc.; 🇺🇸 San Antonio, Texas, United States

Dermatology Clinical Research Center of San Antonio; 🇺🇸 San Antonio, Texas, United States

Great Lakes Research Group, Inc; 🇺🇸 Bay City, Michigan, United States

Acne Treatment & Research Center; 🇺🇸 Morristown, New Jersey, United States

Forefront Dermatology; 🇺🇸 Carmel, Indiana, United States

Mercy Research; 🇺🇸 Washington, Missouri, United States

J &S Studies, Inc; 🇺🇸 College Station, Texas, United States

Schweiger Dermatology, PLLC; 🇺🇸 New York, New York, United States

Skin Sciences, PLLC; 🇺🇸 Louisville, Kentucky, United States

Meridian Clincial Research; 🇺🇸 Dakota Dunes, South Dakota, United States

Meridian Clinical Research; 🇺🇸 Omaha, Nebraska, United States

Meridian Clinical Research, LLC; 🇺🇸 Norfolk, Nebraska, United States

Arlington Dermatology; 🇺🇸 Arlington Heights, Illinois, United States

Kansas City Dermatology, PA; 🇺🇸 Overland Park, Kansas, United States

International Clinical Research-Tennesse LLC; 🇺🇸 Murfreesboro, Tennessee, United States

Fremantle Dermatology; 🇦🇺 Fremantle, Western Australia, Australia

Skin & Cancer Foundation Inc.; 🇦🇺 Carlton, Victoria, Australia

Alliance Dermatology & MOHS Center; 🇺🇸 Phoenix, Arizona, United States

Dermatology Research Associates; 🇺🇸 Los Angeles, California, United States

Anaheim Clinical Trials; 🇺🇸 Anaheim, California, United States

Horizons Clinical Research Center, LLC; 🇺🇸 Denver, Colorado, United States

Dermatology Physicians of CT; 🇺🇸 Shelton, Connecticut, United States

Lenus Research & Medical Group; 🇺🇸 Sweetwater, Florida, United States

International Clinical Research-US, LLC; 🇺🇸 Sanford, Florida, United States

Lawrence Jeffrey Green MD, LLC; 🇺🇸 Rockville, Maryland, United States

Health Awareness, Inc; 🇺🇸 Port Saint Lucie, Florida, United States

DermResearchCenter of New York, Inc.; 🇺🇸 Stony Brook, New York, United States

Quality Clinical Research Inc; 🇺🇸 Omaha, Nebraska, United States

Minnesota Clinical Study Center; 🇺🇸 Fridley, Minnesota, United States

Synexus US, LP, dba, Research Across America; 🇺🇸 Murphy, Texas, United States

Virginia Clinical Research, Inc.; 🇺🇸 Norfolk, Virginia, United States

SimcoDerm Medical and Surgical Dermatology Center; 🇨🇦 Barrie, Ontario, Canada

Research Toronto; 🇨🇦 Toronto, Ontario, Canada

St George Dermatology and Skin Cancer Centre; 🇦🇺 Kogarah, New South Wales, Australia

Lynderm Research Inc.; 🇨🇦 Markham, Ontario, Canada

Finlay Medical Research; 🇺🇸 Miami, Florida, United States

DermResearch; 🇺🇸 Austin, Texas, United States

International Clinical Research - Tennessee LLC; 🇺🇸 Murfreesboro, Tennessee, United States

Windsor Research Inc.; 🇨🇦 Windsor, Ontario, Canada

North Bay Dermatology Centre; 🇨🇦 North Bay, Ontario, Canada

Progressive Clinical Research, PA; 🇺🇸 San Antonio, Texas, United States

Institute for Skin Advancement; 🇨🇦 Calgary, Alberta, Canada

Cyn3rgy Research; 🇺🇸 Gresham, Oregon, United States

Clinical Partners, LLC; 🇺🇸 Johnston, Rhode Island, United States

Woden Dermatology; 🇦🇺 Phillip, Australian Capital Territory, Australia

North Eastern Health Specialists; 🇦🇺 Hectorville, South Australia, Australia