Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

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

NCT04056962

813

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

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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