Conditions: Erythema Rosacea
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 70
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: In this crossover study of CD07805/47 gel 0.5%/CD07805/47 Vehicle and azelaic acid gel 15%, 70 subjects were randomly assigned to treatment sequence.

During Period 1 (15 days), 35 subjects received topical CD07805/47 gel 0.5% in the morning and topical CD07805/47 gel vehicle in the evening, and 35 received topical azelaic acid gel twice daily according to FDA approved prescribing information. Subjects crossed over to the other treatment in Period 2 (15 days).

Interventions: intervention 1: CD07805/47 gel 0.5%/CD07805/47 Vehicle intervention 2: azelaic acid gel 15%
Intervention descriptions: intervention 1: 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 intervention 2: During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily

Protocol document: