Skip to main content
OpenTrials
Completed

NCT Number: NCT07795567

A Study Comparing Ivermectin Cream 1%, Soolantra™ Cream 1%, PrROSIVER® Cream1% to Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sun Pharmaceutical Industries, Inc.

Hawthorne, New York, 10532, United States

About this study

A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ivermectin Cream 1%, to Soolantra™ Cream 1%, PrRosiver® Cream 1% & to Placebo for the treatment of moderate to severe facial rosacea.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial papulopustular rosacea.
  • Subjects must have provided IRB approved written informed consent.
  • Subjects must have a definite clinical diagnosis of facial papulopustular rosacea severity grade 3 or 4 as per the Investigator Global Assessment (IGA) (see Table 1 in the section 6.1)
  • Subjects must have at least 15 and not more than 50 inflammatory facial lesions (i.e., papules/pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts).

Exclusion criteria

  • Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
  • Subjects with a history of hypersensitivity or allergy to ivermectin, propylene glycol, or any of the study medication ingredients.
  • Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of facial rosacea (e.g., on the face: rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, & acne vulgaris).
  • Subjects who currently have or have recently had bacterial folliculitis on the face

Treatment and study plan

Ivermectin cream 1%

Drug

The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.

Other names: Test Product

Soolantra™ Cream 1%

Drug

The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.

Other names: Reference Product

PrRosiver® Cream 1%

Drug

The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.

Other names: Reference Product

Placebo Control

Drug

The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.

Other names: Vehicle of the test product

Primary outcomes

  1. To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product

    Time frame: Baseline to Week 12

    Percent change in the inflammatory (papules and pustules) lesion counts

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.