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

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Jun 6, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a treatment for certain skin growths and blood vessel problems called superficial complicated vascular anomalies, including conditions like Kaposiform Hemangioendothelioma and Tufted Angioma. The researchers want to see if a medication called sirolimus, applied directly to the skin, is safe and effective for treating these conditions, especially in patients who still have skin lesions after taking other medications.

To qualify for the study, participants can be anyone aged 0 to 74 who has been diagnosed with one of the targeted conditions and has a specific type of skin lesion that isn't too extensive. They should not be taking other medications or have undergone recent surgeries, and their medical history needs to be well documented. If eligible, participants will apply the sirolimus treatment and be monitored for any side effects or improvements. It’s important to know that individuals with certain serious health issues or allergies to the medication cannot join. This trial is currently looking for volunteers, so it’s a good opportunity for those who fit the criteria to potentially benefit from this new treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participant clinically or pathologically diagnosed with KHE, TA or complicated superficial vascular anomolies involving lymphatic components.
• • 1. The case is initial, with a relatively limited superficial lesion.
• • 2. The participant has residual surface lesions after oral medication.
• • Participant with no use of other medication or surgical treatment
• • Participant with detailed medical records of the disease at the time of screening
• • Participant with signed and dated informed consent from the guardian(s)
• Exclusion Criteria:
• • Participants with Kasabach-Merritt Phenomenon, with platelets \<50×10 9 /L.
• • Participants with general disease such as hypertension, diabetes, adrenal insufficiency, neurological diseases, liver and kidney dysfunction, and cardiopulmonary insufficiency.
• • Participants with other hematological diseases or solid tumor.
• • Participants allergic to sirolimus or dressing.