NCT06273111|Not Yet RecruitingEarly Phase 1FDA Drug
Topical Simvastatin for Treating Infantile Hemangioma
TSTIH
A Pilot Study Using Topical Statins to Treat Children With Infantile Hemangioma
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Sponsor study identifier
interventional
15
1 country
1
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 15, 2024
Actual (reported)February 22, 2024
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Evaluation of the safety and tolerability of the 5% simvastatin ointment over 48 weeks
The primary endpoint is the evaluation of the safety and tolerability of the 5% simvastatin ointment over 48 weeks, defined by the following three combined components: * Adverse Events: The incidence, severity, and proportion of participants experiencing adverse events (AEs) from Week 0 through Week 48. * Systemic Exposure: The proportion of participants with detectable serum simvastatin levels, alongside descriptive statistics of measured concentrations, at Week 24 (End of Treatment). * Skin Tolerability: The incidence and maximum severity score of local skin reactions at the treatment site at Week 24 (End of Treatment).
Baseline through week 48
To evaluation of the efficacy and durability of the 5% simvastatin ointment over 48 weeks: Key Efficacy Endpoints (Week 24)
Baseline through week 24
To evaluation of the efficacy and durability of the 5% simvastatin ointment over 48 weeks: Treatment Failure and Durability Endpoints
Baseline through week 48
To evaluation of the efficacy and durability of the 5% simvastatin ointment over 48 weeks: Time-to-Event Assessments
Baseline through week 48
Exploratory endpoint
Baseline through week 48
Participants will be applied 5% simvastatin ointment on IH lesion
5% simvastatin ointment will be applied directly on IH lesion twice per day for 24 weeks
Stanford University
Palo Alto, California, 94304, United States
Joyce Teng, MD, PhD
Stanford University
First Submitted
February 15, 2024
First Posted
February 22, 2024
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
March 31, 2028
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 14, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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