Percutaneous Administration of Sirolimus in the Treatment of Superficial Complicated Vascular Anomalies

PHASE4RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

October 22, 2021

Primary Completion Date

November 1, 2025

Study Completion Date

November 1, 2025

Conditions
Kaposiform HemangioendotheliomaTufted AngiomaSuperficial Vascular AnomaliesSuperficial Lymphatic Malformations
Interventions
DRUG

Percutaneous sirolimus

We compare topical and oral use of sirolimus in the treatment of superficial complicted vascular anomalies. In experimental group, we administrate percutaneous sirolimus. Drop 5 ml of sirolimus oral solution and 5 g of dressing into the mixed bottle. Apply mixed gel of topical sirolimus to affected area. Use it twice a day for 6 months.

DRUG

Oral sirolimus

We compare topical and oral use of sirolimus in the treatment of superficial complicted vascular anomalies. In active comparator group, we administrate oral sirolimus. Oral dose of sirolimus is calculated according to body surface area. Take it twice a day for 6 months. Maintain the blood concentration of sirolimus at 5-15ng/ml.

Trial Locations (1)

210012

RECRUITING

Children's Hospital of Fudan University, Shanghai

All Listed Sponsors
lead

Children's Hospital of Fudan University

OTHER