Back to resultsTacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma
Primary Purpose
Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Tacrolimus ointment
Sponsored by
About this trial
This is an interventional treatment trial for Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma
Eligibility 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)
Sites / Locations
- West China Hospital of Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients treated with Tacrolimus ointment
Arm Description
Outcomes
Primary Outcome Measures
reduction in the size of the lesion
Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.
Secondary Outcome Measures
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.).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04056962
Brief Title
Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma
Official Title
Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma: a Single Arm Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
October 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
West China Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patients treated with Tacrolimus ointment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus ointment
Intervention Description
topical application of tacrolimus for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
Primary Outcome Measure Information:
Title
reduction in the size of the lesion
Description
Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.
Time Frame
2.5 years
Secondary Outcome Measure Information:
Title
Rate of Adverse events
Description
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.).
Time Frame
2.5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Ji, PHD, MD
Phone
+86 13980544622
Email
jijiyuanyuan@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Ji
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi Ji, MD
Phone
86 18980606865
Email
jijiyuanyuan@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma
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