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NCT06273111: TSTIH

Topical Simvastatin for Treating Infantile Hemangioma

Status unknown EARLY_PHASE1 Last updated 22 February 2024
What this trial tests

EARLY_PHASE1 trial testing 5% simvastatin ointment in Hemangioma Skin in 12 participants. Status unknown.

Timeline
1 April 2024
Primary endpoint
31 July 2025
31 December 2025

Quick facts

Lead sponsorJoyce Teng
PhaseEARLY_PHASE1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date1 April 2024
Primary completion31 July 2025
Estimated completion31 December 2025
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Joyce Teng — full company profile →

Who can join

Adults 3 Months to 5, any sex, with Hemangioma Skin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Targeted medical therapies for vascular anomalies.
    Borst A. · · 2024 · cited 1× · PMID 39644074 · DOI 10.1182/hematology.2024000599

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing