NCT04056962

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2019

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
Last Updated

May 7, 2024

Status Verified

May 1, 2024

Enrollment Period

5 years

First QC Date

August 11, 2019

Last Update Submit

May 4, 2024

Conditions

Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Rate of Adverse events

    2.5 years

Study Arms (2)

patients treated with tacrolimus 0.03% ointment

EXPERIMENTAL

patients treated with tacrolimus 0.03% ointment

Drug: Tacrolimus ointment

patients treated with tacrolimus 0.1% ointment

ACTIVE COMPARATOR

patients treated with tacrolimus 0.1% ointment

Drug: Tacrolimus ointment

Interventions

Tacrolimus ointmentDRUG

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

patients treated with tacrolimus 0.03% ointmentpatients treated with tacrolimus 0.1% ointment

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)

You may not qualify if:

  • Hypersensitivity to Tacrolimus Mucosal Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Kaposiform HemangioendotheliomaTufted angioma

Study Officials

  • Yi Ji

    West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Ji, PHD, MD

CONTACT

+86 13980544622jijiyuanyuan@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of Philosophy, Doctor of Medicine

Study Record Dates

First Submitted

August 11, 2019

First Posted

August 14, 2019

Study Start

September 1, 2019

Primary Completion

August 30, 2024

Study Completion

October 28, 2024

Last Updated

May 7, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)