Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

Phase 2

Recruiting

• Conditions: Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma
• Interventions: Drug: Tacrolimus ointment

• Registration Number: NCT04056962
• Lead Sponsor: West China Hospital

Brief Summary

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

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 at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Study Timeline

• Study First Submitted: 2019-08-11
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Study Start: 2019-09-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-04
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-08-30
• Study Completion: 2024-10-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients treated with tacrolimus 0.1% ointment	Tacrolimus ointment	patients treated with tacrolimus 0.1% ointment
patients treated with tacrolimus 0.03% ointment	Tacrolimus ointment	patients treated with tacrolimus 0.03% ointment

Primary Outcome Measures

Name	Time	Method
reduction in the size of the lesion	2.5 years	Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.

Secondary Outcome Measures

Name	Time	Method
Rate of Adverse events	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.).

Trial Locations

Locations (1)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China