The purpose of this vehicle controlled study is to evaluate the efficacy and safety of CD07805/47 gel 0.5% applied topically once daily (QD) for 4 weeks, and CD07805/47 gel 0.18% applied topically once daily (QD) or twice daily (BID) for 4 weeks, in subjects with moderate to severe facial erythema associated with rosacea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
269
CD07805/47 Gel 0.5% QD
Vehicle Gel QD
CD07805/47 Gel 0.18% QD
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States
Composite Success
Composite success defined as 2-grade improvement on Clinician Erythema Assessment (CEA)and Patient Self Assessment-5 (PSA-5). Each concentration/regimen was compared to its respective placebo control as part of the primary analysis.
Time frame: Day 29
CEA Success
CEA success defined as 2-grade improvement on CEA. Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. Clinician Erythema Assessment (CEA) - Grade/Description 0 / Clear Skin with no signs of erythema 1. / Amost clear; slight redness 2. / Mild erythema; definite redness 3. / Moderate erythema; marked redness 4. / Severe erythema; fiery redness
Time frame: Day 29
PSA-5 Success
Each concentration/regimen was compared to its respective placebo control as part of the primary analysis. PSA-5 success defined as 2-grade improvement on PSA-5. Patient Self Assessment - 5 (PSA-5) - Grade/description 0 / No redness 1. / Very mild redness 2. / Mild redness 3. / Moderate redness 4. / Severe redness
Time frame: day 29
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