UnknownEarly Phase 1

Topical Simvastatin for Treating Infantile Hemangioma

United States12 participantsStarted 2024-04-01

Plain-language summary

This is a 24-week, open-label pilot study to evaluate the safety and preliminary efficacy of 5% simvastatin ointment in treating 12 children with superficial IH. The primary objective: To evaluate the safety and tolerability of topical treatment with 5% simvastatin ointment for superficial IH over 24 weeks. The secondary objective: 1.1 To evaluate the efficacy of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks. Evaluation is performed at each clinic visit via investigator global assessment (IGA) based on standardized 3D digital photography and hemangioma activity score (HAS). 1.2 To evaluate the impact of 5% simvastatin ointment on quality of life using the IH-QoL questionnaire.

Who can participate

Age range

3 Months – 5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Healthy children aged between 3 months and 5 years. * Newly diagnosed superficial IH or experiencing rebound growth with a superficial component. * Participants must possess at least one IH lesion with the longest diameter equal to or greater than 2 cm, located on any part of the body except the lips. * Participants must not have received any of the following treatments for their IH: * Topical medical therapy within the past 2 weeks. * Systemic medical therapy within the past 3 months. * Laser treatment within the past 6 weeks. * Written informed consent from the parent(s)/guardian(s) of minor participants must be obtained before any study procedure is performed. Exclusion Criteria: * IH is primarily characterized as subcutaneous, and deep, with minimal cutaneous involvement for evaluation. * IH with active ulceration. * IH to be treated involving the lips mainly. * Participants with concurrent skin conditions that may impede accurate clinical assessment of the IH. * Participants with hereditary or metabolic disorders requiring systemic statin therapy. * Participants who are allergic to statins, or other ingredients present in the topical medication.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Treatment-Related Adverse Events

Timeframe: Baseline through week 24

Trial details

NCT IDNCT06273111

SponsorJoyce Teng

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

Contact for this trial

Joyce Teng, MD, PhD

650-724-9627 jteng3@stanford.edu

View on ClinicalTrials.gov More Hemangioma Skin trials