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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
122
0.5% Topical Gel
0.18% Topical Gel
0.07% Topical Gel
Vehicle Topical Gel
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Philadephia Institute of Dermatology
Fort Washington, Pennsylvania, United States
Derm Research, Inc
Austin, Texas, United States
J&S Studies
College Station, Texas, United States
The Education & Research Foundation
Lynchburg, Virginia, United States
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
Time frame: Baseline and every hour for 12 hours following application
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