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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% (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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07795567
Enrollment
865
Registered
2026-08-31
Start date
2025-12-09
Completion date
2026-06-24
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Brief 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.

Detailed description

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.

Interventions

DRUGIvermectin Cream 1%

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

DRUGSoolantra™ Cream 1%

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

DRUGPrRosiver® Cream 1%

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

DRUGPlacebo Control

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

Sponsors

Sun Pharmaceutical Industries, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational productBaseline to Week 12Percent change in the inflammatory (papules and pustules) lesion counts

Countries

United States

Contacts

STUDY_DIRECTORNatalie Yantovskiy

Sun Pharmaceuticals Industries, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026