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Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

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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

Tracking Information
First Submitted Date  ICMJE August 11, 2019
First Posted Date  ICMJE August 14, 2019
Last Update Posted Date October 3, 2019
Actual Study Start Date  ICMJE September 1, 2019
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2019)
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.).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma
Official Title  ICMJE Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma: a Single Arm Prospective Study
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma
Intervention  ICMJE Drug: Tacrolimus ointment
topical application of tacrolimus for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
Study Arms  ICMJE Experimental: patients treated with Tacrolimus ointment
Intervention: Drug: Tacrolimus ointment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 12, 2019)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date August 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yi Ji, PHD, MD +86 13980544622 jijiyuanyuan@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04056962
Other Study ID Numbers  ICMJE 813
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yi Ji, West China Hospital
Study Sponsor  ICMJE West China Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yi Ji West China Hospital
PRS Account West China Hospital
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP