Skip to content

Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma

Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma:a Randomized Controlled Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04056962
Enrollment
50
Registered
2019-08-14
Start date
2019-09-01
Completion date
2024-10-28
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma

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).

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

Interventions

DRUGTacrolimus ointment

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

Sponsors

West China Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
0 Years to 18 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
reduction in the size of the lesion2.5 yearsTherapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.

Secondary

MeasureTime frameDescription
Rate of Adverse events2.5 yearsusing 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.).

Countries

China

Contacts

Primary ContactYi Ji, PHD, MD
jijiyuanyuan@163.com+86 13980544622

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026