Percutaneous Administration of Sirolimus in the Treatment of Superficial Complicated Vascular Anomalies: a Randomized Controlled Trial
Who is this study for? Pediatric and young adult patients with various complicated vascular anomalies
What treatments are being studied? Percutaneous sirolimus
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
In this study, we investigate the safety and efficacy of topical sirolimus in the treatment of superficial complicated vascular anomolies.
Eligibility
Participation Requirements
Sex: All
Maximum Age: 18
Healthy Volunteers: f
View:
• Participant clinically or pathologically diagnosed with KHE, TA or complicated superficial vascular anomolies involving lymphatic components.
‣ The case is initial, with a relatively limited superficial lesion.
⁃ 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)
Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Time Frame
Start Date: 2021-10-22
Estimated Completion Date: 2025-11-01
Participants
Target number of participants: 75
Treatments
Experimental: Topical use of 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.
Active_comparator: Oral use of 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.
Related Therapeutic Areas
Sponsors
Leads: Children's Hospital of Fudan University