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Completed NCT07795567

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

Conditions: Rosacea

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 865
Sponsor: Sun Pharmaceutical Industries, Inc.

Location: Sun Pharmaceutical Industries, Inc. Hawthorne New York

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07795567). StuddyBuddy aggregates publicly available trial information.