drugset / Trial / NCT01174030

Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema Associated With Rosacea

NCT01174030 ↗

Phase 2 Completed 269 enrolled Galderma R&D
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2010-08
Primary completion
2010-12
Completion
2011-01

Outcome

Mixed primary results

registry CD07805/47 Gel 0.5% QD vs Vehicle Gel QD; p <0.001; Odds Ratio (OR) 8.392 (95% CI 2.637 to 26.710) NCT01174030 ↗

registry CD07805/47 Gel 0.18% QD vs Vehicle Gel QD; p = 0.027; Odds Ratio (OR) 3.738 (95% CI 1.097 to 12.742) NCT01174030 ↗

registry CD07805/47 Gel 0.18% BID vs Vehicle Gel BID; p = 0.549; Odds Ratio (OR) 1.269 (95% CI 0.586 to 2.747) NCT01174030 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Brimonidine Unknown 0.18 % Topical
Subject Brimonidine Unknown 0.5 % Topical

Indications