Phase 3 Papulopustular Rosacea Study
- Registration Number
- NCT01494467
- Lead Sponsor
- Galderma R&D
- Brief Summary
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 688
- The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
- The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
- The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
- The subject has rosacea with more than two nodules on the face.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CD5024 Vehicle Azelaic acid 15% Gel CD5024 Vehicle Cream CD5024 CD5024 CD5024 1% Cream
- Primary Outcome Measures
Name Time Method Success Rate Week 12 Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.
Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:
Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)Absolute Change in Inflammatory Lesion Count Baseline to Week 12 Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
- Secondary Outcome Measures
Name Time Method Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) Baseline to Week 12 Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Trial Locations
- Locations (48)
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Guildford Dermatology Specialists
🇨🇦Surrey, British Columbia, Canada
Total Skin and Beauty
🇺🇸Birmingham, Alabama, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Oregon Dermatology and Research Center
🇺🇸Portland, Oregon, United States
Dermatology Reserach Associates
🇺🇸Nashville, Tennessee, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Dermatology Specialists, Inc
🇺🇸Oceanside, California, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Integrated Research Group, Inc
🇺🇸Riverside, California, United States
ATS Clinical Research
🇺🇸Santa Monica, California, United States
FXM Research Corp Miami
🇺🇸Miami, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC
🇺🇸Alpharetta, Georgia, United States
Redwood Dermatology Research
🇺🇸Santa Rosa, California, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
Leavitt Medical Associates of Florida dba Ameriderm Research
🇺🇸Ormond Beach, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Deaconess Clinic, Inc.
🇺🇸Evansville, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States
Northeast Dermatology Associates
🇺🇸Beverly, Massachusetts, United States
Hamzavi Dermatology
🇺🇸Fort Gratiot, Michigan, United States
David Fivenson, MD, PLC
🇺🇸Ann Arbor, Michigan, United States
Dermatology Clinical Trials Unit
🇺🇸Saint Louis, Missouri, United States
Somerset Skin Centre
🇺🇸Troy, Michigan, United States
Psoriasis Treatment Center of NJ
🇺🇸West Windsor, New Jersey, United States
Academic Dermatology Associates
🇺🇸Albuquerque, New Mexico, United States
DermResearch Center of New York, Inc
🇺🇸Stony Brook, New York, United States
PMG Research of Raleigh, LLC
🇺🇸Raleigh, North Carolina, United States
Dermatology and Skin Surgery Center
🇺🇸Exton, Pennsylvania, United States
Penn State Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Philadelphia Institute of Dermatology
🇺🇸Fort Washington, Pennsylvania, United States
Paddington Research
🇺🇸Philadelphia, Pennsylvania, United States
Yardley Dermatology Associates
🇺🇸Yardley, Pennsylvania, United States
Arlington Research Center, Inc
🇺🇸Arlington, Texas, United States
Center for Clinical Studies
🇺🇸Webster, Texas, United States
The Skin Wellness Center
🇺🇸Knoxville, Tennessee, United States
Stephen Miller MD
🇺🇸San Antonio, Texas, United States
Ultranova Skincare
🇨🇦Barrie, Ontario, Canada
Dermatrials Research
🇨🇦Hamilton, Ontario, Canada
The Guenther Dermatology Research Center
🇨🇦London, Ontario, Canada
Lynderm Research Inc
🇨🇦Markham, Ontario, Canada
North Bay Dermatology Centre, Inc
🇨🇦North Bay, Ontario, Canada
XLR8 Medical Research, Inc
🇨🇦Windsor, Ontario, Canada
International Dermatology Research, Inc
🇨🇦Montreal, Quebec, Canada
Centre de Recherche Dermatologique du Quebec Metropolitan
🇨🇦Quebec, Canada
The Centre for Dermatology & Cosmetic Surgery
🇨🇦Richmond Hill, Ontario, Canada