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

Kaposiform Hemangioendothelioma Clinical Trial

Official title: Percutaneous Administration of Sirolimus in the Treatment of Superficial Complicated Vascular Anomalies: a Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

In this study, we investigate the safety and efficacy of topical sirolimus in the treatment of superficial complicated vascular anomolies.

Clinical Trial Description

Vascular anomaly is a kind of rare disease. According to histology, biological behavior and clinical manifestations, it can be divided into two categories: vascular tumor and vascular malformation. mTOR inhibitors are proved with the properties of anti-proliferation and anti-angiogenesis. Therefore, they have been used in the treatment of vascular anomalies. Sirolimus, by its ability to prevent downstream protein synthesis and subsequent cell proliferation and angiogenesis, has become a novel and effective treatment. However, after the children reach complete response, there may still be skin manifestations that affect the appearance and cause psychological shadows. Therefore, intervention is required. Studies have reported that topical sirolimus is effective in treating Kaposiform Hemangioendothelioma (KHE). It is absorbed through the skin, avoiding the first pass elimination effect of the liver. Fewer adverse reactions have been observed. In this study, we investigate the efficacy and safety of percutaneous administration of sirolimus in the treatment of superficial complicated vascular anomalies. ;

Related Conditions & MeSH terms

• Congenital Abnormalities
• Hemangioendothelioma
• Kaposiform Hemangioendothelioma
• Lymphangioma
• Lymphatic Abnormalities
• Tufted Angioma
• Vascular Malformations

• NCT number: NCT04921722
• Study type: Interventional
• Source: Children's Hospital of Fudan University
• Status: Recruiting
• Phase: Phase 4
• Start date: October 22, 2021
• Completion date: November 1, 2025