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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. ;


Study Design


Related Conditions & MeSH terms


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

See also
  Status Clinical Trial Phase
Completed NCT04077515 - Safety and Efficacy of Low-dose Sirolimus to Kaposiform Hemangioendothelioma Phase 4
Recruiting NCT05351216 - The Effect of Sirolimus on Immunizations During the Treatment of Kaposiform Hemangioendothelioma
Completed NCT03188068 - Sirolimus Versus Sirolimus Plus Prednisolone for Kaposiform Hemangioendothelioma Phase 2
Completed NCT04448873 - Guided Discontinuation Versus Maintenance Treatment of Sirolimus in Pediatric Patients With Kaposiform Hemangioendothelioma Phase 4
Completed NCT04775173 - Efficacy and Safety of Different Concentrations of Sirolimus in the Treatment of Kaposiform Hemangioendothelioma. Phase 2
Recruiting NCT03001180 - Identification of Biomarkers for Patients With Vascular Anomalies