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

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.

• Ivermectin Cream 1% (Drug), also known as Test Product: 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% (Drug), also known as Reference Product: 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% (Drug), also known as Reference Product: 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 (Drug), also known as Vehicle of the test product: The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.

Primary outcomes

• To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product [Baseline to Week 12]: Percent change in the inflammatory (papules and pustules) lesion counts

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial papulopustular rosacea.
2. Subjects must have provided IRB approved written informed consent.
3. 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)
4. 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:

1. Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
2. Subjects with a history of hypersensitivity or allergy to ivermectin, propylene glycol, or any of the study medication ingredients.
3. 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).
4. Subjects who currently have or have recently had bacterial folliculitis on the face

• Natalie Yantovskiy, Study director, Sun Pharmaceuticals Industries, Inc.