Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

• Sponsor: West China Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04056962
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 37.9
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma	Drug: Tacrolimus ointment	Phase 4

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).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma: a Single Arm Prospective Study
• Actual Study Start Date: Sep 1, 2019
• Anticipated Primary Completion Date: Aug 30, 2022
• Anticipated Study Completion Date: Oct 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: patients treated with Tacrolimus ointment	Drug: Tacrolimus ointment; topical application of tacrolimus for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• West China Hospital

Investigators

• Principal Investigator: Yi Ji, West China Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yi Ji, Doctor of Philosophy, Doctor of Medicine, West China Hospital
• ClinicalTrials.gov Identifier: NCT04056962
• Other Study ID Numbers: 813
• First Posted: Aug 14, 2019
• Last Update Posted: Jan 4, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sarcoma, Kaposi; Hemangioendothelioma; Hemangioma; Kasabach-Merritt Syndrome; Skin Neoplasms; Tacrolimus

Study Results

No Results Posted as of Jan 4, 2022