Conditions: Moderate to Severe Papulopustular Rosacea
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 630
Healthy volunteers: no

Brief summary:
A randomized, double-blind, placebo-controlled, parallel-design, multiple-site clinical study to evaluate the therapeutic equivalence and safety of ivermectin cream 1% (Actavis Laboratories UT, Inc.) to SoolantraTM (ivermectin) cream 1% (Galderma) in the treatment of moderate to severe papulopustular rosacea.

Detailed description:

Arms:
arm 1: test product, manufactured by Actavis Laboratories UT, Inc. arm 2: reference product, manufactured by Galderma Laboratories, L.P. arm 3: Placebo, manufactured by Actavis Laboratories UT, Inc.

Interventions: intervention 1: Ivermectin Cream, 1% intervention 2: Placebo/Vehicle cream
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: