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Statin cream put to the test against infantile hemangioma

NCT ID NCT06273111

Symptom relief Sponsor: Joyce Teng 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Infantile hemangioma is a common birthmark that can grow quickly in a baby's first months. Researchers are testing a 5% simvastatin ointment applied directly to the skin of babies aged 3 to 6 months with newly diagnosed superficial hemangiomas. The study checks whether the ointment is safe and well tolerated over 48 weeks, and whether it can shrink the hemangioma or keep it from growing back after treatment stops.

What this could mean

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

Active substance
5% simvastatin ointment applied to the skin
What this could lead to
If it works, a skin cream could offer a way to treat infantile hemangiomas without pills, injections, or surgery.
What could go wrong
This is a very early, small study in 15 babies, so it may not show a clear benefit or may not work for all hemangiomas. Skin irritation at the treatment site is a possible risk.

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 15 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

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

3 to 6 months

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: Participants may be included in the study only if they meet all of the following criteria: 1. Healthy children aged between 3-6 months without medical disorders that contradict topical statin treatment. 2. Infants with newly diagnosed superficial IH. \[3\] Participants must possess at least one IH lesion with the longest diameter equal to or greater than 1 cm but less than 1% BSA, located on any part of the body except the lips. \[4\] Written informed consent from the parent(s)/guardian(s) must be obtained before any study procedure is performed. \[5\] Parent(s)/guardian(s) are willing to comply with the study protocol Exclusion Criteria: Participants meeting any of the following criteria will not be eligible to participate in the study: 1. IH is primarily characterized as subcutaneous, and deep, with minimal cutaneous involvement for evaluation. 2. IH with active ulceration at screening visit. 3. IH to be treated involving the lips mainly. 4. IH with high-risk criteria that need systemic propranolol treatment to avoid the delay with standard treatment 5. Participants with concurrent skin conditions that may impede accurate clinical assessment of the IH. 6. Participants with hereditary or metabolic disorders requiring systemic statin therapy. 7. Participants who are allergic to statins, or other ingredients present in the topical medication. 8. Participants who have received any of the following treatments for their IH: i) Topical medical therapy, i.e. imiquimod, sirolimus, timolol, intermediate or high strength steroids, etc. within the past 4 weeks ii) Systemic medical therapy, i.e. beta blockers, steroids, sirolimus for IH within the past 3 months iii) Surgical intervention including laser treatment within the past 6 weeks

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Conditions

The condition(s) this trial relates to.

capillary hemangioma skin hemangioma

As listed by the trial registrant

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

Hemangioma skin

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

  • Stanford University

    Palo Alto, California, 94304, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.