Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea (MOSAIC)

NCT02616250 Phase 4 COMPLETED Results posted

The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.

Details

Lead sponsor	Galderma R&D
Phase	Phase 4
Status	COMPLETED
Enrolment	190
Start date	2015-12
Completion	2016-09

Conditions

• Rosacea

Interventions

• Brimonidine 0.33% gel (Br)
• CD07805/47 (Br) placebo gel
• Ivermectin 1% cream (IVM)
• CD5024 (IVM) placebo cream

Primary outcomes

• Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA): — week 12/Hour 3
  Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)

Countries

United States, Canada