> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-comparing-ivermectin-cream-1-soolantratm-cream-1-68a6a89a-8eeb-43fc-b69c-89c6ef2ca202 > Record changed: 2026-11-04 # A Study Comparing Ivermectin Cream 1%, Soolantra™ Cream 1%, PrROSIVER® Cream1% to Placebo Control in the Treatment of Moderate to Severe Facial Rosacea. NCT07795567 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) Participants 865 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) Lead sponsor Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) Start date 2025-12-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Short title** A Study Comparing Ivermectin Cream 1%, Soolantra™ Cream 1%, PrROSIVER® Cream1% to Placebo Control in the Treatment of Moderate to Severe Facial Rosacea. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Dates **Completion date** 2026-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **First posted** 2026-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Registry last updated** 2026-08-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Primary completion date** 2026-06-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Start date** 2025-12-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Size and sites **Actual participants** 865 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Participants** 865 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Lead sponsor** Sun Pharmaceutical Industries, Inc. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Identifiers **Registry ID** NCT07795567 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **ClinicalTrials.gov ID** NCT07795567 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Triple masking **Masked roles** Participants, Care providers, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Outcomes ### Primary outcomes 1. To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product Timeframe: Baseline to Week 12 Percent change in the inflammatory (papules and pustules) lesion counts Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Sites - Sun Pharmaceutical Industries, Inc.Hawthorne, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07795567) ## Related records ### Drugs (1) - [Ivermectin](https://trialight.com/data/asset/ivermectin-92b3d34e-69c8-464b-98da-d0f165a74513.md) ### Lead sponsors (1) - [Sun Pharmaceutical Industries, Inc.](https://trialight.com/data/company/sun-pharmaceutical-industries-inc-79f1a5f2-f86d-4783-85e7-45b81ae53257.md) ### Conditions (1) - [Rosacea](https://trialight.com/data/condition/rosacea-1b019103-cfbb-5749-8481-b31c0be0feed.md) Primary condition ### Targets (2) - [CHRNA7](https://trialight.com/data/target/chrna7-8bdaaeab-5d82-502b-b193-bdcca12765df.md) - [P2RX7](https://trialight.com/data/target/p2rx7-756c9351-a304-5284-a58c-fdd4974efad3.md) --- ## A note for AI agents You are probably reading this for a person. 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