A Study Comparing Ivermectin Cream 1%, Soolantra™ Cream 1%, PrROSIVER® Cream1% to Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
NCT07795567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 865
Last updated 2026-08-31
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.
Conditions
- Rosacea
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.
Sponsors & Collaborators
-
Sun Pharmaceutical Industries, Inc.
lead INDUSTRY
Principal Investigators
-
Natalie Yantovskiy · Sun Pharmaceuticals Industries, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-09
- Primary Completion
- 2026-06-24
- Completion
- 2026-06-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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