Retrospective validation study for assessment of skin lesion in vascular anomalies

Retrospective validation study for assessment of skin lesion in vascular anomalies - Retrospective validation study for assessment of skin lesion in vascular anomalies

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042388

Enrollment

Registered

2020-11-09

Start date

2020-10-25

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Vascular anomalies (venous malformation, lymphatic malformation, tufted angioma, kaposiform hemangioendothelioma)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients diagnosed with vascular abnormalities (venous malformations, lymphatic malformations, tufted angioma, Kaposiform hemangioendothelioma, etc.) from January 1, 2015 to December 31, 2020 2) Patients with lesions on the skin that can be evaluated by medical examination and clinical photographs

Exclusion criteria

Exclusion criteria: 1) Patients with visceral vascular abnormalities only 2) Patients who underwent resection of the lesion during the evaluation period. However, drug therapy (including Kampo, propranolol, oral sirolimus, and topical agents) is acceptable. 3) Patients with obvious infection or inflammation at the lesion site

Design outcomes

Primary

Measure	Time frame
Correlation coefficient between the external evaluation score of the target lesion and the amount of change in the lesion volume using the "criteria for improving the skin symptoms of vascular abnormalities (size, color)", and "the skin symptoms of vascular abnormalities Correlation coefficient (co-primary endpoints) between the external evaluation score of the target lesion and the amount of change in the color tone score (PANTONE color sample scoring) using the "improvement criteria (size, color)"	—

Measure

Time frame

Correlation coefficient between the external evaluation score of the target lesion and the amount of change in the lesion volume using the "criteria for improving the skin symptoms of vascular abnormalities (size, color)", and "the skin symptoms of vascular abnormalities Correlation coefficient (co-primary endpoints) between the external evaluation score of the target lesion and the amount of change in the color tone score (PANTONE color sample scoring) using the "improvement criteria (size, color)"

—

Secondary

Measure	Time frame
Correlation between the external evaluation score of the target lesion using the criteria for improving skin symptoms of vascular abnormalities (size, color) and the amount of change in the color tone score Correlation coefficient between the external evaluation score of the target lesion and the amount of change in the lesion volume using the criteria (size) for the degree of improvement of skin symptoms of vascular abnormalities Correlation coefficient between the external evaluation score of the target lesion using the criteria (size) for the degree of improvement of skin symptoms of vascular abnormalities Correlation coefficient between the external evaluation score of the target lesion using the criteria for improving skin symptoms of vascular abnormalities (color) and the amount of change in the color tone score (PANTONE color sample scoring)	—

Measure

Time frame

Correlation between the external evaluation score of the target lesion using the criteria for improving skin symptoms of vascular abnormalities (size, color) and the amount of change in the color tone score Correlation coefficient between the external evaluation score of the target lesion and the amount of change in the lesion volume using the criteria (size) for the degree of improvement of skin symptoms of vascular abnormalities Correlation coefficient between the external evaluation score of the target lesion using the criteria (size) for the degree of improvement of skin symptoms of vascular abnormalities Correlation coefficient between the external evaluation score of the target lesion using the criteria for improving skin symptoms of vascular abnormalities (color) and the amount of change in the color tone score (PANTONE color sample scoring)

—

Countries

Japan

Contacts

Public ContactMichio Ozeki

Gifu University Hospital Pediatrics

michioo@gifu-u.ac.jp058-230-6000

Outcome results