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COMPLETED
NCT07795567
PHASE1

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.

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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.

DRUG

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.

DRUG

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