Topical Sirolimus in Cutaneous Lymphatic Malformations

Inclusion Criteria: * 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) Exclusion Criteria: * Patients with lymphatic malformation requiring a continued background 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 (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus, etc) * Local fungal, viral (Herpes Simplex Virus, Varicella Zoster Virus, 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 contrace…