Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-24 @ 3:51 PM
NCT ID:
NCT03972592
Eligibility Criteria:
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 contraceptive method until the end of the study
* Pregnant or breastfeeding women
* Subject already involved in another therapeutic trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT03972592
Study Brief:
Protocol Section:
NCT03972592