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Can a skin gel shrink stubborn birthmarks?

NCT ID NCT07813533

Symptom relief Sponsor: Northwestern University 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are testing whether a topical gel containing sirolimus can flatten raised epidermal nevi and even out their color. The study enrolls people aged 6 and older who have had stable, non-inflammatory epidermal nevi for at least three years. Participants apply the gel twice daily for 12 weeks, and doctors compare before-and-after photographs to score how much the nevi improve.

What this could mean

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

Active substance
topical sirolimus gel 0.2%
What this could lead to
If it works, topical sirolimus could offer a non-surgical way to shrink raised epidermal nevi and even out skin color, especially for lesions that are hard to remove.
What could go wrong
This is an early-phase pilot with only 14 participants, so any benefit seen may not hold up in larger studies. Topical sirolimus can cause skin irritation, and the 12-week treatment window may be too short to show lasting change.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

6 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: * Patients 6 years of age or above with a non-inflammatory epidermal nevi * Lesion(s) that have been present for at least 3 years and are relatively stable * At least 2 cm in length (ideally continuous, but can be cumulatively) * The lesions is raised, hyperpigmented compared to the surrounding skin, and is noninflammatory with a physician global assessment (PGA) of at least 3 (moderate). * Agree to avoid emollient use at the nevus site throughout the study * Agree to not bath or shower 2 hours post-application, knowing that the gel can be applied after bathing or showering. Exclusion Criteria: * Patients currently or recently (within past 4 weeks) using a topical keratolytic or topical anti-inflammatory medication at the lesional site (i.e. topical steroid, topical retinoid, alpha-OH acid) * Pregnant or planning to become pregnant during the course of the study

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Conditions

The condition(s) this trial relates to.

nevus, epidermal Nevus, Sebaceous of Jadassohn

As listed by the trial registrant

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

Epidermal nevi

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology

    Chicago, Illinois, 60611, United States