Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
LK210106
Description
In this study, we investigate the safety and efficacy of topical sirolimus in the treatment of superficial complicated vascular anomolies.
Trial arms
Trial start
2021-10-22
Estimated PCD
2025-11-01
Trial end
2025-11-01
Status
Recruiting
Phase
Early phase I
Treatment
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.
Arms:
Topical use of sirolimus
Other names:
Rapamycin
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.
Arms:
Oral use of sirolimus
Other names:
Rapamycin
Size
75
Primary endpoint
Effective rate
From admission to follow-up six months
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2024-03-15

1 organization

1 product

4 indications

Organization
Children's Hospital of Fudan University
Product
Sirolimus
Indication
Kaposiform Hemangioendothelioma
Indication
Tufted Hemangioma
Indication
Vascular Anomalies
Indication
Superficial Lymphatic Malformations