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Can a generic cream match Brand-Name rosacea treatments?

NCT ID NCT07795567

Disease control Sponsor: Sun Pharmaceutical Industries, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial tests whether a generic ivermectin cream works as well as two brand-name versions for treating moderate to severe facial rosacea. Adults with the condition apply the cream once daily for 84 days. Researchers compare changes in inflammatory lesions and check safety against a placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ivermectin cream 1%
What this could lead to
If it works, this could offer a more affordable treatment option for moderate to severe facial rosacea, with similar effectiveness to existing brand-name creams.
What could go wrong
This is an early-phase trial, so results may not hold up in larger studies. The cream may not prove as effective as the reference products, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

865 people

The number who actually took part.

Started

Dec 2025

Finished

Jun 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

rosacea

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rosacea

Contacts and locations

Locations

  • Sun Pharmaceutical Industries, Inc.

    Hawthorne, New York, 10532, United States

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