NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2051210126

Registered date:26/11/2021

WMU-NPC-1

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedPatients with cutaneous manifestation with vascular
Date of first enrollment07/12/2021
Target sample size50
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)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.

Outcome(s)

Primary OutcomeImprovement of target lesions by central judgment after 12 weeks of treatment
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 01month old
Age maximumNot applicable
GenderBoth
Include criteria1)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
Exclude criteria1)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

Related Information

Contact

Public contact
Name Masatoshi Jinnin
Address 811-1, Kimiidera, Wakayama city, Wakayama,Japan,641-8510 Wakayama Japan 641-8510
Telephone +81-73-441-0661
E-mail mjin@wakayama-med.ac.jp
Affiliation Wakayama Medical University Hospital
Scientific contact
Name Masatoshi Jinnin
Address 811-1, Kimiidera, Wakayama city, Wakayama,Japan,641-8510 Wakayama Japan 641-8510
Telephone +81-73-441-0661
E-mail mjin@wakayama-med.ac.jp
Affiliation Wakayama Medical University Hospital