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

NCT07795567 | Completed Phase 1 FDA Drug

• 1 other identifier: IVRC-2502
• Study Type: interventional
• Target: 865
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

• To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product

  Percent change in the inflammatory (papules and pustules) lesion counts

  Baseline to Week 12

Study Arms (4)

Ivermectin Cream 1%

EXPERIMENTAL

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

Drug: Ivermectin Cream 1%

Soolantra™ Cream 1%

ACTIVE COMPARATOR

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

Drug: Soolantra™ Cream 1%

PrRosiver® Cream 1%

ACTIVE COMPARATOR

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

Drug: PrRosiver® Cream 1%

Placebo Control

PLACEBO COMPARATOR

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

Drug: Placebo Control

Interventions

Ivermectin Cream 1% DRUG

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

Also known as: Test Product

Ivermectin Cream 1%

Soolantra™ Cream 1% DRUG

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

Also known as: Reference Product

Soolantra™ Cream 1%

PrRosiver® Cream 1% DRUG

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

Also known as: Reference Product

PrRosiver® Cream 1%

Placebo Control DRUG

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

Also known as: Vehicle of the test product

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

Study Sites (1)

Sun Pharmaceutical Industries, Inc.

Hawthorne, New York, 10532, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Natalie Yantovskiy

  Sun Pharmaceuticals Industries, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: December 9, 2025
• Primary Completion: June 24, 2026
• Study Completion: June 24, 2026
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)