A Phase 1 interventional study of Ivermectin Cream 1% and Soolantra™ Cream 1% in Rosacea, sponsored by Sun Pharmaceutical Industries, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Sun Pharmaceutical Industries, Inc. · Phase 1, Interventional, and Treatment
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.
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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 865 is above the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Sun Pharmaceutical Industries, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%
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%
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%
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
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
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
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
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
To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product
Percent change in the inflammatory (papules and pustules) lesion counts
Time frame: Baseline to Week 12
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2025 to primary completion in Jun 2026, 6 months.
Of 13 phase 1 interventional studies under Rosacea, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 13. This study's 6 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ivermectin
Sun Pharmaceutical Industries, Inc. →