Phase 3 Papulopustular Rosacea Study
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 PPR and continues to be safe up to 12 months.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.|
- Success Rate [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
The percentage of stubjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 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 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]Inflammatory lesion counts will be conducted at each visit by the Investigator or study coordinator.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
CD5024 1% Cream
CD5024 1% Cream, once daily
Placebo Comparator: CD5024 Vehicle
CD5024 Vehicle Cream
Drug: Azelaic acid 15% Gel
Topical Gel applied twice daily
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