Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma Clinical Trial

Official title:

Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma：a Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04056962
• Other study ID #: 813
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2019
• Est. completion date: October 28, 2024

Study information

• Verified date: May 2024
• Source: West China Hospital
• Contact: Yi Ji, PHD, MD
• Phone: +86 13980544622
• Email: jijiyuanyuan[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 28, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemangioendothelioma
• Hemangioma
• Kasabach-Merritt Syndrome
• Sarcoma, Kaposi
• Skin Neoplasms
• Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma

Intervention

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

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in the size of the lesion	Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.	2.5 years
Secondary	Rate of Adverse events	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.).	2.5 years