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A Study Comparing Ivermectin Cream 1%, Soolantra™ Cream 1%, PrROSIVER® Cream1% to Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
Sponsor: Sun Pharmaceutical Industries, Inc.
Summary
The goal of this clinical trial is to evaluate and demonstrate the therapeutic equivalence and safety of Ivermectin Cream 1%, Soolantra™ Cream 1%, PrRosiver® Cream 1% \& to Placebo for the treatment of moderate to severe facial rosacea.
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Ivermectin Cream 1% (Taro Pharmaceutical Industries, Inc.) To Soolantra™ Cream 1% (US Reference Listed Drug), PrRosiver® Cream 1% (Canadian Reference Product), and Each Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
865
Start Date
2025-12-09
Completion Date
2026-06-24
Last Updated
2026-08-31
Healthy Volunteers
No
Conditions
Interventions
Ivermectin Cream 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Soolantra™ Cream 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
PrRosiver® Cream 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Placebo Control
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
Locations (1)
Sun Pharmaceutical Industries, Inc.
Hawthorne, New York, United States