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NOT YET RECRUITING
NCT06273111
EARLY_PHASE1

Topical Simvastatin for Treating Infantile Hemangioma

Sponsor: Joyce Teng

View on ClinicalTrials.gov

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

DRUG

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