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)
Total Skin and Beauty
🇺🇸Birmingham, Alabama, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Dermatology Specialists, Inc
🇺🇸Oceanside, California, United States
Integrated Research Group, Inc
🇺🇸Riverside, California, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
ATS Clinical Research
🇺🇸Santa Monica, California, United States
Redwood Dermatology Research
🇺🇸Santa Rosa, California, United States
FXM Research Corp Miami
🇺🇸Miami, Florida, United States
Scroll for more (38 remaining)Total Skin and Beauty🇺🇸Birmingham, Alabama, United States