Phase 3 Papulopustular Rosacea Study

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.

Timeline

Start

2011-12

Primary completion

2013-08

Completion

2013-08

Outcome

Met primary endpoint

registry CD5024 1% Cream vs CD5024 Vehicle Cream; p <0.001; Cochran-Mantel-Haenszel NCT01494467 ↗

registry CD5024 1% Cream vs CD5024 Vehicle Cream; p <0.001; Mean Difference (Net) -8.22 (95% CI -10.18 to -6.25); ANCOVA NCT01494467 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Azelaic acid	Small molecule	15 %	Topical
Subject	Ivermectin	Small molecule	1 %	—

Indications