NCT06273111

Topical Simvastatin for Treating Infantile Hemangioma

A Pilot Study Using Topical Statins to Treat Children With Infantile Hemangioma

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Joyce Teng · Academic / Other
• Sex: All
• Age: 3 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hemangioma Skin

Interventions

Type	Name	Description
DRUG	5% simvastatin ointment	5% simvastatin ointment will be applied directly on IH lesion twice per day for 24 weeks

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-07-31
• Completion: 2025-12-31
• First posted: 2024-02-22
• Last updated: 2024-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study