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Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.
Details
| Lead sponsor | Galderma R&D |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 122 |
| Start date | 2009-09 |
| Completion | 2009-12 |
Conditions
- Erythematotelangiectatic Rosacea
Interventions
- CD07805/47
- CD07805/47
- CD07805/47
- CD07805/47 placebo
Primary outcomes
- Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing. — Baseline and every hour for 12 hours following application
Countries
United States