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Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

S

Sichuan University

Status and phase

Enrolling
Phase 2

Conditions

Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma

Treatments

Drug: Tacrolimus ointment

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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).

Full 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 at different concentrations for superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).

Enrollment

50 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

patients treated with tacrolimus 0.03% ointment
Experimental group
Description:
patients treated with tacrolimus 0.03% ointment
Treatment:
Drug: Tacrolimus ointment
patients treated with tacrolimus 0.1% ointment
Active Comparator group
Description:
patients treated with tacrolimus 0.1% ointment
Treatment:
Drug: Tacrolimus ointment

Trial contacts and locations

1

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Central trial contact

Yi Ji, PHD, MD

Data sourced from clinicaltrials.gov

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