A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris
- Registration Number
- NCT02431052
- Lead Sponsor
- Dermira, Inc.
- Brief Summary
The objectives of this study are to assess the safety and efficacy DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 420
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, Vehicle QD Vehicle Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, Vehicle BID Vehicle Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, 7.5% BID Olumacostat Glasaretil Olumacostat Glasaretil Gel, 7.5%, 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
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
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 (33)
T. Joseph Raoof, MD, Inc.
🇺🇸Encino, California, United States
Skin Search of Rochester, Inc.
🇺🇸Rochester, New York, United States
The Education & Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States
International Clinical Research - US, LLC
🇺🇸Sanford, Florida, United States
Lawrence J. Green, MD, LLC
🇺🇸Rockville, Maryland, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
DermResearch, PLLC
🇺🇸Louisville, Kentucky, United States
Dermatology Research Center, Inc.
🇺🇸Salt Lake City, Utah, United States
Tory Sullivan MD PA
🇺🇸North Miami Beach, Florida, United States
Windsor Clinical Research, Inc.
🇨🇦Windsor, Ontario, Canada
Centre de Recherche Dermetologique du Quebec Metropolitain (CRDQ)
🇨🇦Quebec, Canada
Center for Clinical Studies, LTD. LLP
🇺🇸Houston, Texas, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
University Clinical Trials, Inc.
🇺🇸San Diego, California, United States
Visions Clinical Research
🇺🇸Wellington, Florida, United States
DermResearch, Inc
🇺🇸Austin, Texas, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
Enverus Medical Research
🇨🇦Surrey, British Columbia, Canada
Lynderm Research
🇨🇦Markham, Ontario, Canada
The Skin Wellness Center
🇺🇸Knoxville, Tennessee, United States
Kirk Barber Research
🇨🇦Calgary, Alberta, Canada
Austin Institute for Clinical Research
🇺🇸Pflugerville, Texas, United States
Innovaderm Research Inc.
🇨🇦Montreal, Quebec, Canada
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Michigan Center for Skin Care Research
🇺🇸Clinton Township, Michigan, United States
Las Vegas Dermatology
🇺🇸Las Vegas, Nevada, United States
International Clinical Research - Tennessee LLC
🇺🇸Murfreesboro, Tennessee, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
MOORE Clinical Research, Inc.
🇺🇸Tampa, Florida, United States
J&S Studies, Inc.
🇺🇸College Station, Texas, United States
Dermatology Consulting Services
🇺🇸High Point, North Carolina, United States
Suzanne Bruce & Associates, PA. The Center for Skin Research
🇺🇸Katy, Texas, United States
Progressive Clinical Research, PA
🇺🇸San Antonio, Texas, United States