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 Papulopustular Rosacea (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: Week 12 ] [ Designated as safety issue: No ]
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 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]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).
- Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]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).
|Study Start Date:||December 2011|
|Study Completion Date:||August 2013|
|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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01494467
Show 50 Study Locations
|Study Director:||Michael Graeber, M.D.||Galderma R&D, LLC|