Evaluation of the Efficacy of CANNABIDIOL on the Pruritus in Children With Hereditary Epidermolysis Bullosa (EBCBD)
Hereditary Epidermolysis Bullosa
About this trial
This is an interventional treatment trial for Hereditary Epidermolysis Bullosa focused on measuring hereditary epidermolysis bullosa, Cannabidiol, Prutitus, Pilot Study
Eligibility Criteria
Inclusion Criteria: Minor patient between 2 and 17 years and 10 months Suffering from distrophic recessive epidermolysis bullosa Patient weight less than or equal to 40 kg With pruritus not relieved by conventional treatments with mean VAS greater than or equal to 4/10 the 3 days preceding inclusion No change in treatment or care for at least one month Consent of parents Affiliated to social security Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients (Refined sesame oil, anhydrous ethanol, sucralose, strawberry flavor, includes benzyl alcohol) Consumption of cannabis or cannabidiol Severe renal impairment defined by GFR less than 29 ml/min Moderate to severe hepatic impairment defined by a Child-Pugh B or C score or an AST and/or ALT level greater than 3 times normal and/or bilirubin more than 2 times normal with clinically or ultrasound sign(s) of moderate to severe cardiac insufficiency, defined by LVEF less than 45% and stage II to IV of the NYHA classification Taking a tricyclic antidepressant treatment with anti-H4 antihistamine action or a neurokinin-1 receptor antagonist in the previous month Participating to an interventional research (category 1 or 2) Modification of at least one background treatment in the previous month Proven pregnancy or breastfeeding patient Patient deprived of their liberty by decision of a judicial or administrative authority (Article L. 1121-6 of the Public Health Code)
Sites / Locations
- Hôpital Necker Enfants MaladesRecruiting
Arms of the Study
Arm 1
Experimental
Cannabidiol (Epidyolex)