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
- 2013-07
- Completion
- 2013-08
Outcome
Met primary endpoint
registry NUMBER CD5024 1% Cream: 38.4 Percentage of participants NUMBER CD5024 Vehicle Cream: 11.6 Percentage of participants NCT01493687 ↗
registry analysis (unspecified test); CD5024 1% Cream vs CD5024 Vehicle Cream; p <0.001; Cochran-Mantel-Haenszel NCT01493687 ↗
registry MEAN CD5024 1% Cream: -20.5 (Standard Deviation 15.95) Lesion count change MEAN CD5024 Vehicle Cream: -12.0 (Standard Deviation 13.55) Lesion count change NCT01493687 ↗
registry analysis (unspecified test); CD5024 1% Cream vs CD5024 Vehicle Cream; p <0.001; Mean Difference (Net) -8.13 (95% CI -10.12 to -6.13); ANCOVA NCT01493687 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ivermectin | Small molecule | 1 % | — |