臨床研究等提出・公開システム

A randomized, multicenter, double-blind, placebo-controlled clinical trial of sirolimus gel in cutaneous manifestation of patients with vascular

WMU-NPC-1

Jinnin Masatoshi

Wakayama Medical University Hospital

811-1, Kimiidera, Wakayama city, Wakayama,Japan,641-8510

mjin@wakayama-med.ac.jp

Jinnin Masatoshi

Wakayama Medical University Hospital

811-1, Kimiidera, Wakayama city, Wakayama,Japan,641-8510

+81-73-441-0661

mjin@wakayama-med.ac.jp

Not Recruiting

Dec. 07, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1) Patients who are at least one month old
2) Patients with skin lesions diagnosed as venous malformation or lymphatic malformation (lymphangioma or lymphangiomatosis) according to the criteria by center for specific pediatric chronic diseases, or diagnosed as tufted hemangioma or Kaposiform hemangioendothelioma according to Japanese clinical practice guidelines for vascular anomalies 2017
3) Patients with target lesions that do not show a tendency to disappear within 4 weeks of interview and are visible on photographs.
4) Patients for whom written consent for participation in the study has been obtained from the subject and/or a substitute (if the subject is under 20 years of age at the time of obtaining consent).
5) Patients who have no intention to participate in other clinical trials, clinical studies, or observational studies while participating in this study

1) Patients who have received oral treatment with mTOR inhibitors (sirolimus, everolimus, temsirolimus, etc.) within 12 weeks prior to registration
2) Patients who have participated in other clinical trials within 6 months prior to registration
3) Patients who have received treatment for the target lesion (surgical, endovascular, laser, phototherapy, liquid nitrogen therapy, elastic bandage) within 3 months prior to registration
4) Patients who have received drugs used for the treatment of the target disease, such as immunosuppressive agents (oral and topical), anticancer drugs, propranolol, radiotherapy, steroid pulse therapy, oral steroids for more than one month, interferon, Yuexuekazhu Tang, Huangqi Jianzhong Tang, etc., within 3 months prior to registration
5) Patients with skin lesions such as severe erosions or ulcers on the target lesion
6) Patients with significant bleeding in the target lesion
7) Patients with infectious diseases in the target lesion
8) Patients with malignant tumors, infections, serious cardiac, hepatic, renal, or hematological diseases (determined by the investigator referring to grade 2 or higher in the Japanese translation of CTCAEv5.0 JCOG)
9) Patients with a history of allergy to sirolimus, macrolide antibiotics, or additives used in the investigational product
10) Patients with immunodeficiency such as HIV, primary immunodeficiency, etc.
11) Patients who fall under at least one of the following
Pregnant or may be pregnant
Breast-feeding
Do not agree to use contraception during this study
12) Patients who do not agree to avoid direct sunlight to the application site during this study
13) Patients who are judged by the investigator to be inappropriate for this study

Both

Patients with cutaneous manifestation with vascular

The investigational drug (placebo group, 0.2% sirolimus group, and 0.4% sirolimus group) will be applied twice a day (morning and before bedtime) for 12 consecutive weeks.

Improvement of target lesions by central judgment after 12 weeks of treatment

+81-73-447-2300

Oct. 26, 2021

No

none