0.1% topical sirolimus in the treatment of cutaneous microcystic lymphatic malformations in children and adults: phase II, split-body randomized, double-blind, vehicle-controlled clinical trial - TOPICA

CHRU TOURS0 个研究点目标入组 55 人开始时间: 2018年7月23日最近更新: 2019年4月30日

适应症

试验速览

暂无简介。

•-Patients = 6 years
•-Updated immunization schedule
•-Diagnosis of primary cutaneous microcystic lymphatic malformation (CMLM) confirmed by histopathological or dermoscopic examination, with or without an underlying malformation or a syndromic malformation (Protée syndrome for instance), responsible for impairment (oozing, bleeding and/or pain)
•-CMLM = 20 cm2, that can be divided into 2 parts of similar severity
•-Informed, written consent of the subject and his/her parents if < 18 years
•-Rights to French social security (including CMU)
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Patients with lymphatic malformation requiring a continued backround therapy (involving deep organs)
•-Secondary lymphatic malformations (lymphangiectasia post-radiotherapy, etc)
•-Previous treatment with oral or topical mTOR inhibitors within 12 months before inclusion
•-Previous treatment with oral or topical steroids within 10 days before inclusion
•-Immunosuppression (immunosuppressive disease or immunosuppressive treatment)
•-Ongoing neoplasia
•-Active chronic infectious disease (HBV, HCV, HIV, etc)
•-Local fungal, viral (HSV, VZV, etc) or bacterial infection on the site of the CMLM (based on clinical examination)
•-Skin necrosis
•-Known allergy to one of the components of the topical sirolimus preparation or vehicle
•-Women of child-bearing potential (including teenagers) not using a reliable contraceptive method until the end of the study
•-Pregnant or breastfeeding women
•-Subject already involved in another therapeutic trial

发起方

CHRU TOURS