The purpose of this study is to compare the efficacy and assess the safety of CD07805/47 gel 0.5% applied topically once daily versus azelaic acid gel 15% applied topically twice daily in subjects with moderate to severe facial erythema of rosacea.
Adult subjects with moderate to severe facial erythema of rosacea who meet inclusion/exclusion criteria will be randomized at Baseline/Visit 1 in a 1:1 ratio to receive either CD07805/47 gel 0.5% once daily or azelaic acid gel 15% twice daily for 15 days. Following an appropriate washout period, subjects will then switch treatments and use the second investigational product as instructed for 15 days (according to the subject's randomization scheme). Subjects will re-qualify based upon inclusion/exclusion prior to Period 2 treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle. During each treatment period (baseline to Day 15): CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily
During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily
Hudson Dermatology
Evansville, Indiana, United States
Dermatology Specialists Research, LLC
Louisville, Kentucky, United States
DermResearch, Inc
Austin, Texas, United States
The Education & Research Foundation, Inc.
Lynchburg, Virginia, United States
Composite Success
Composite Success, defined as a 2-grade improvement at 6 hours on both the clinician's and subject's erythema assessments at the end of each treatment period
Time frame: Hour 6 on Day 15
Onset of Action
Onset of action, defined as an improvement on both the clinician's and subject's erythema assessments at 30 minutes post baseline application
Time frame: 30 minutes after baseline treatment application on Day 15
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