A pilot study with sirolimus-gel for vascular abnormality

JRCT ID: jRCTs051190032

Registered date:22/07/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Vascular abnormality
• Date of first enrollment: 22/07/2019
• Target sample size: 10
• Study type: Interventional
• Intervention(s): Topical administration of 0.2% sirolimus-gel twice daily for 12 weeks

Outcome(s)

Primary Outcome

Evaluation of safety
Incidence of adverse events for which causality cannot be ruled out

Secondary Outcome

Improvement rate of skin lesions (size and color) after 2,6,12 weeks of treatment.
Satisfactory rate by patients.

Key inclusion & exclusion criteria

• Age minimum: >= 3age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kaneda Mari