A Phase 2 interventional study of Tacrolimus ointment in Tacrolimus, Kaposiform Hemangioendothelioma, Tufted Angioma, sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 0 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-07.
Sponsored by West China Hospital · Phase 2, Interventional, and Treatment
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).
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).
West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients treated with tacrolimus 0.03% ointment
Drug: Tacrolimus ointment
patients treated with tacrolimus 0.1% ointment
Drug: Tacrolimus ointment
topical application of tacrolimus at different concentrations for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
reduction in the size of the lesion
Therapeutic effect is evaluated by reduction in the size of the tumor measured by centimeters.
Time frame: 2.5 years
Rate of Adverse events
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.).
Time frame: 2.5 years
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2019 (actual). Primary completion is estimated for Aug 2024, 59 months after the start.
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Studies of the drug tested here: Tacrolimus
Kaposiform Hemangioendothelioma