Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

Overview

The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Full Title of Study: “Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma: a Single Arm Prospective Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 30, 2024

Detailed Description

Kaposiform hemangioendothelioma (KHE) and tufted angiomas (TA) are rare vascular tumors, which are apparent predominantly in infancy or early childhood. Currently, no standard treatment regimens exist for KHE/TA. The aim of this study was to evaluate the efficacy and safety of topical application of tacrolimus for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Interventions

  • Drug: Tacrolimus ointment
    • topical application of tacrolimus for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Arms, Groups and Cohorts

  • Experimental: patients treated with Tacrolimus ointment

Clinical Trial Outcome Measures

Primary Measures

  • reduction in the size of the lesion
    • Time Frame: 2.5 years
    • Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.

Secondary Measures

  • Rate of Adverse events
    • Time Frame: 2.5 years
    • using the measurement of ratio to evaluate the rate of adverse events of topical application of tacrolimus (such as ratio of Acne vulgaris, pruritis and rash etc.).

Participating in This Clinical Trial

Inclusion Criteria

  • Children with superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA) Exclusion Criteria:

  • Hypersensitivity to Tacrolimus Mucosal Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)

Gender Eligibility: All

Minimum Age: 0 Years

Maximum Age: 18 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • West China Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yi Ji, Doctor of Philosophy, Doctor of Medicine – West China Hospital
  • Overall Official(s)
    • Yi Ji, Principal Investigator, West China Hospital
  • Overall Contact(s)
    • Yi Ji, PHD, MD, +86 13980544622, jijiyuanyuan@163.com

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