A 4-week, Randomized, Double-blind, Parallel-group, Vehicle-controlled, Multicenter Study Investigating the Efficacy and Safety of CD07805/47 Gel 0.5% Applied Topically Once Daily (QD), and CD07805/47 Gel 0.18% Applied Topically Once Daily (QD) or Twice Daily (BID), in Subjects With Moderate to Severe Facial Erythema Associated With Rosacea

NCT01174030 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Galderma R&D
Phase	Phase 2
Status	COMPLETED
Enrolment	269
Start date	2010-08
Completion	2011-01

Conditions

• Rosacea

Interventions

• CD07805/47 Gel
• Vehicle Gel
• CD07805/47 Gel
• CD07805/47 Gel
• Vehicle Gel

Primary outcomes

• Composite Success — Day 29
  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.

Countries

United States