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Topical Simvastatin for Treating Infantile Hemangioma
Sponsor: Joyce Teng
Summary
This is a 48-week, open-label pilot study to evaluate the safety, including systemic exposure and skin tolerability, and preliminary efficacy of 5% simvastatin ointment in the treatment of 15 children with newly diagnosed superficial proliferating IH. The primary objective: To evaluate the safety, including systemic exposure and skin tolerability of topical treatment with 5% simvastatin ointment for superficial proliferating IH over 48 weeks. The secondary objective: 1.1 To evaluate the efficacy and durability of 5% simvastatin ointment when topical treatment is administered twice daily for 24 weeks, followed by a 24-week post-treatment follow-up period. 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. The exploratory objective: To explore whether clinical response and regrowth following topical 5% simvastatin treatment are associated with SOX18-mevalonate pathway-axis activation in infantile hemangioma tissue.
Official title: A Pilot Study Using Topical Statins to Treat Children With Infantile Hemangioma
Key Details
Gender
All
Age Range
3 Months - 6 Months
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2026-11-01
Completion Date
2029-06-30
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
5% simvastatin ointment
5% simvastatin ointment will be applied directly on IH lesion twice per day for 24 weeks
Locations (1)
Stanford University
Palo Alto, California, United States