A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
- Conditions
- Acne Vulgaris
- Interventions
- Drug: Olumacostat Glasaretil Gel, 5.0%Other: Olumacostat Glasaretil Gel, Vehicle
- Registration Number
- NCT03073486
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 744
-
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
- 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 (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
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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (45)
Advanced Skincare Surgery & MedCenter
🇺🇸Fullerton, California, United States
Enverus Medical Research
🇨🇦Surrey, British Columbia, Canada
Synexus US, LP, dba, Research Across America
🇺🇸Dallas, Texas, United States
Northwest Arkansas Clinical Trials Center
🇺🇸Rogers, Arkansas, United States
Avant Research Associates, LLC
🇺🇸Guntersville, Alabama, United States
Florida Academic Centers Research & Education
🇺🇸Coral Gables, Florida, United States
Center for Clincial and Cosmetic Research
🇺🇸Aventura, Florida, United States
Pioneer Clinical Research
🇺🇸Pembroke Pines, Florida, United States
Visions Clinical Research
🇺🇸Wellington, Florida, United States
Clinical Trials Management, LLC
🇺🇸Metairie, Louisiana, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
Premier Specialists
🇦🇺Kogarah, Australia
Premier Clinical Research
🇺🇸Spokane, Washington, United States
The Skin Centre
🇦🇺Benowa, Australia
Avant Research Associates
🇺🇸Beaumont, Texas, United States
Sinclair Dermatology
🇦🇺Melbourne, Australia
Houston Center for Clinical Research
🇺🇸Sugar Land, Texas, United States
Wiseman Dermatology Research Inc.
🇨🇦Winnipeg, Manitoba, Canada
DermEdge Research
🇨🇦Mississauga, Ontario, Canada
The Centre for Dermatology
🇨🇦Richmond Hill, Ontario, Canada
Veracity Clinical Research
🇦🇺Woolloongabba, Australia
Advanced Research Associates
🇺🇸Glendale, Arizona, United States
Dermatology Trial Associates
🇺🇸Bryant, Arkansas, United States
Center for Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Aby's New GEneration Research Inc.
🇺🇸Hialeah, Florida, United States
Radiant Research, Inc.
🇺🇸Pinellas Park, Florida, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Marietta Dermatology Clinical Research, Inc.
🇺🇸Marietta, Georgia, United States
The Skin Wellness Center
🇺🇸Knoxville, Tennessee, United States
Suzanne Bruce and Associates, P.A. The Center for Skin
🇺🇸Houston, Texas, United States
The Education & Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States
Burswood Dermatology
🇦🇺Victoria Park, Australia
Austin Institute for Clinical Research, Inc
🇺🇸Pflugerville, Texas, United States
XLR8 Medical Research
🇨🇦Windsor, Ontario, Canada
Northern California Research
🇺🇸Sacramento, California, United States
TCR Medical Corporation
🇺🇸San Diego, California, United States
Floridian Research Institute
🇺🇸Miami, Florida, United States
MOORE Clinical Research, Inc
🇺🇸Tampa, Florida, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Henry Ford Medical Center, New Center One
🇺🇸Detroit, Michigan, United States
JDR Dermatology Research, LLC
🇺🇸Las Vegas, Nevada, United States
Sterling Research Group
🇺🇸Cincinnati, Ohio, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States