Vascular abnormality Vascular abnormality
Conditions
Interventions
Sponsors
Kaneda Mari
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients diagnosed as vascular abnormality based on the diagnostic guideline 2017 of hemangioma, vascular malformations and lymphatic malformations at the pre-enrollment test. 2)Patients for whom no other effective therapies are available 3)Patients who have localized skin lesions to be evaluable at the pre-enrollment test. 4)Patients, or the legal representative who give the written consent to join the study by its free will after receiving the adequate explanations. 5)Patients who is 3 years old or elder.
Exclusion criteria
Exclusion criteria: 1)Patients who are not able to follow the planned topical administration of the test drug or not able to make the regular study observation. 2)Patients who have allergy to macrolide antibiotics 3)Patients who treated with oral administration of sirolimus or everolimus within 12 months prior to enrollment. 4)Patients who treated with topical administration of sirolimus, or everolimus within 6 months prior to enrollment. 5)Patients who treated with propranolol within 6 months prior to enrollment. 6)Patients who treated with sclerotherapy within 12 months prior to enrollment. 7)Patients who treated with laser or radiation therapy within 12 months prior to enrollment. 8)Patients who are pregnant or lactating. 9)Patients judged by the physician in charge not appropriate to join the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety Incidence of adverse events for which causality cannot be ruled out | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement rate of skin lesions (size and color) after 2,6,12 weeks of treatment. Satisfactory rate by patients. | — |
Contacts
Public ContactMari Kaneda
Osaka University Hospital
Outcome results
None listed