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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Success Rate

Outcome Description:

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

Outcome Time Frame:

Baseline to Week 12

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

RD.06.SPR.18170

NCT ID:

NCT01493687

Start Date:

December 2011

Completion Date:

August 2013

Related Keywords:

• Papulopustular Rosacea (PPR)
• Rosacea