Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
114
Galderma Investigational Site
Montpellier, France
Galderma Investigational Site
Nice, France
Galderma Investigational Site
Chelyabinsk, Russia
Galderma Investigational Site
Moscow, Russia
Composite Success Assessment (CEA) and Patient Self Assessment(PSA).
Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
Time frame: Day 29
Composite Success Assessment (CEA) and Patient Self Assessment(PSA).
30 Minutes Effect is defined as 1 grade improvement on CEA and PSA at 30 minutes.
Time frame: D1
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Galderma Investigational Site
Saint Petersburg, Russia
Galderma Investigational Site
Yekaterinburg, Russia
Galderma Investigational Site
Eskilstuna, Sweden