NCT01493687

Phase 3 Papulopustular Rosacea Study

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 683 (actual)
• Sponsor: Galderma R&D · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Papulopustular Rosacea (PPR)

Interventions

Type	Name	Description
DRUG	CD5024	CD5024 1% Cream, once daily
DRUG	Azelaic acid 15% Gel	Topical Gel applied twice daily

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-07-01
• Completion: 2013-08-01
• First posted: 2011-12-16
• Last updated: 2021-02-18
• Results posted: 2015-01-16

Locations

50 sites across 2 countries: United States, Canada