A Study Comparing Ivermectin Cream 1%, Soolantra™ Cream 1%, PrROSIVER® Cream1% to Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
NCT07795567
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Sun Pharmaceutical Industries, Inc.
Start date
2025-12-09
Number of sites
- 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.
- 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.
- 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.
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-06-24
- First posted
- 2026-08-31
- Registry last updated
- 2026-08-31
- Primary completion date
- 2026-06-24
- Start date
- 2025-12-09
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07795567
- ClinicalTrials.gov ID
- NCT07795567
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Triple masking
- Masked roles
- Participants, Care providers, Investigators
Sources for study design
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
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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).
- 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
Sources for eligibility
- Sun Pharmaceutical Industries, Inc.Hawthorne, United States
Sources for sites
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Rosacea Primary condition