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TOPical sirolimus in linGUal microkystic lymphatic malformation
EU CTIS ID: 2024-515955-39-01
What this study is testing
To evaluate the efficacy and safety of a 1mg/mL sirolimus solution applied once daily on the anterior part of lingual microcystic lymphatic malformation of any stage in children and adults after 4, 8, 12, 16, 20 and 24 weeks of treatment as compared to usual care (no treatment).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- ≥ 5 years of age
- Lingual microcystic lymphatic malformation of any stage (Wiegand 2009) assessed by clinical examination and head-and-neck MRI imaging prior to study enrolment, with or without underlying syndromic malformation (CLAPO for instance)
- Participants covered by or having the rights to social security
- Written informed consent obtained from participant and participant’s legal representative if participant is under 18
- Ability for participant to comply with the requirements of the study
- Compliance with the French mandatory immunization program
You likely can't join if
- Patients with a lymphatic malformation requiring a continued background therapy (involving deep organs)
- 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
See the full eligibility criteria
- ≥ 5 years of age
- Lingual microcystic lymphatic malformation of any stage (Wiegand 2009) assessed by clinical examination and head-and-neck MRI imaging prior to study enrolment, with or without underlying syndromic malformation (CLAPO for instance)
- Participants covered by or having the rights to social security
- Written informed consent obtained from participant and participant’s legal representative if participant is under 18
- Ability for participant to comply with the requirements of the study
- Compliance with the French mandatory immunization program
- Patients with a lymphatic malformation requiring a continued background therapy (involving deep organs)
- 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
- Secondary lymphatic malformations (lymphangiectasia post-radiotherapy, etc)
- Previous treatment with systemic or topical mTOR inhibitors within 6 months before inclusion (half-life of oral sirolimus is 60 hours in adults according to Rapamune ® Summary of Product Characteristics)
- 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 (HBV, HCV, HIV, etc)
- Local necrosis
- Local fungal, viral (HSV, VZV, etc) or bacterial infection on the site of the LMLM (based on clinical examination)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.