TOPical Sirolimus in linGUal Microcystic Lymphatic Malformation -TOPGUN

Exclusion Criteria

• •Patients with a lymphatic malformation requiring a continued background therapy (involving deep organs)
• •Secondary lymphatic malformations (lymphangiectasia post-radiotherapy, etc)
• •Previous treatment with systemic or topical mTOR (mammilian target of rapamycin) inhibitors within 12 months before inclusion (half-life of oral sirolimus is 60 days in adults).
• •Previous treatment with oral or topical steroids within 10 days before inclusion (half-life of corticosteroids is 12-36 hours)
• •Immunosuppression (immunosuppressive disease or immunosuppressive treatment)
• •Ongoing neoplasia
• •Active chronic infectious disease (Hepatitis-B virus, Hepatitis-C virus, HIV, etc)
• •Local necrosis
• •Local fungal, viral (herpes simplex virus, varicella zoster virus, etc) or bacterial infection on the site of the LMLM (based on clinical examination)
• •Known allergy to one of the components of the sirolimus solution
• •Soy bean or Peanut allergy
• •Pregnant or breastfeeding women
• •Women of child-bearing potential (including teenagers) not using a reliable contraceptive method until the end of the study and three month after the end of the study or sirolimus discontinuation.
• •Already involved in another therapeutic trial