Phase 3 Papulopustular Rosacea Study
- Conditions
- Papulopustular Rosacea (PPR)
- Interventions
- Drug: Azelaic acid 15% Gel
- Registration Number
- NCT01493687
- 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
- 683
- 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 (50)
Dermatology Associates of Kingsport, PC
🇺🇸Kingsport, Tennessee, United States
Eastern Canada Cutaneous Research Associates
🇨🇦Halifax, Nova Scotia, Canada
UAB Dermatology Clinical Research
🇺🇸Birmingham, Alabama, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Northwest AR Clinical Trials Center
🇺🇸Rogers, Arkansas, United States
The Dermatology and Aesthetic Center
🇺🇸Boca Raton, Florida, United States
Cherry Creek Research, Inc.
🇺🇸Denver, Colorado, United States
Research Across America
🇺🇸Santa Ana, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
FXM Research Miramar
🇺🇸Miramar, Florida, United States
University Clinical Trials
🇺🇸San Diego, California, United States
North Florida Dermatology Associates
🇺🇸Jacksonville, Florida, United States
The Center for Clinical & Cosmetic Research
🇺🇸Aventura, Florida, United States
MedaPhase, Inc.
🇺🇸Newnan, Georgia, United States
Laser & Skin Surgery Center of Indiana
🇺🇸Carmel, Indiana, United States
The South Bend Clinic, LLP
🇺🇸South Bend, Indiana, United States
The Indiana Clinical Trials Center
🇺🇸Plainfield, Indiana, United States
Derm Research, PLLC
🇺🇸Louisville, Kentucky, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Henry Ford Health Systems Department of Dermatology
🇺🇸Detroit, Michigan, United States
Lawrence Green, MD, LLC
🇺🇸Rockville, Maryland, United States
Central Dermatology PC
🇺🇸Saint Louis, Missouri, United States
Anderson & Collins Clinical Research,
🇺🇸Edison, New Jersey, United States
PMG Research of Charlotte
🇺🇸Charlotte, North Carolina, United States
Department of Dermatology - Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Dermatology Research Center of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Haber Dermatology Clinical Research Center
🇺🇸South Euclid, Ohio, United States
Baker Allergy, Asthma and Dermatology Research Center
🇺🇸Lake Oswego, Oregon, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Simpsonville, South Carolina, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
TriCities Skin and Cancer
🇺🇸Johnson City, Tennessee, United States
PMG Research of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
Modern Research Associates
🇺🇸Dallas, Texas, United States
The Polyclinic
🇺🇸Seattle, Washington, United States
The Education & Research Foundation, Inc.
🇺🇸Lynchburg, Virginia, United States
Center for Clinical Studies
🇺🇸Houston, Texas, United States
PLLC dba Dermatology Associates
🇺🇸Seattle, Washington, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Dermatology Research Center, Inc.
🇺🇸Salt Lake City, Utah, United States
Stratica Medical Inc
🇨🇦Edmonton, Alberta, Canada
Dermadvances Research
🇨🇦Winnepeg, Manitoba, Canada
Derm Research@888 Inc.
🇨🇦Vancouver, British Columbia, Canada
Nexus Clinical Research
🇨🇦St John's, Newfoundland and Labrador, Canada
Skin Centre for Dermatology
🇨🇦Peterborough, Ontario, Canada
Toronto Research Centre, Inc.
🇨🇦Toronto, Ontario, Canada
Windsor Clinical Research, Inc.
🇨🇦Windsor, Ontario, Canada
Siena Medical
🇨🇦Montreal, Quebec, Canada
Innovaderm Research. Inc
🇨🇦Montreal, Quebec, Canada
DermResearch, Inc.
🇺🇸Austin, Texas, United States