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Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04056962
Recruitment Status : Recruiting
First Posted : August 14, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Yi Ji, West China Hospital

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : September 1, 2019
Estimated Primary Completion Date : August 30, 2021
Estimated Study Completion Date : February 28, 2022


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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04056962


Contacts
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Contact: Yi Ji, PHD, MD +86 13980544622 jijiyuanyuan@163.com

Locations
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China, Sichuan
West China Hospital of Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Yi Ji, MD    86 18980606865    jijiyuanyuan@163.com   
Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Yi Ji West China Hospital

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Responsible Party: Yi Ji, Doctor of Philosophy, Doctor of Medicine, West China Hospital
ClinicalTrials.gov Identifier: NCT04056962    
Other Study ID Numbers: 813
First Posted: August 14, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sarcoma, Kaposi
Hemangioendothelioma
Hemangioma
Kasabach-Merritt Syndrome
Skin Neoplasms
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Sarcoma
Neoplasms, Connective and Soft Tissue
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Neoplasms by Site
Skin Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action