Informations générales (source: ClinicalTrials.gov)

NCT03453632 Statut inconnu
Evaluation of the Efficacy of Injections of Botulinic Toxin in Plantar Lesions of Patients Suffering From Localized Epidermolysis Bullosa Simplex : Double Blind Randomized Controlled Study. (EBTox)
Interventional
  • Épidermolyse bulleuse
  • Épidermolyse bulleuse simple
Phase 2/Phase 3
University Hospital, Toulouse (Voir sur ClinicalTrials)
juin 2018
décembre 2023
02 août 2025
The investigators hypothesize that palmar injections of botulinic toxin, via an inhibition of the sudation, would limit the occurrence of blisters in localized epidermolysis bullosa simplex (LEBS).
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
University Hospital Bordeaux - 33000 - Bordeaux - France Olivier COGREL, MD En recrutement Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Hôpital Larrey - CHU Toulouse - 31059 - Toulouse - France Juliette Mazereeuw-Hautier, Pr En recrutement Contact (sur clinicalTrials)
Saint-Louis Hospital - APHP - 75000 - Paris - France Emmanuel Bourrat, MD En recrutement Contact (sur clinicalTrials)
University Hospital Nice - 06000 - Nice - France Christine CHIAVERINI, MD En recrutement Contact (sur clinicalTrials)

Critères

Tous
Inclusion Criteria:

- Diagnosis of LEBS based on clinical symptoms and in some cases histological or
molecular findings

- Palmar skin lesions: blisters and/or : erosions, edematous and erythematous lesions,
crusts. 3 lesions per foot, as a minimum

- Similar clinical severity of skin lesions on both feet

- Patient with social security

- Written consent of the patient

- Patient able to understand the study's questionnaires



- Patients with only one leg and a different number of toes on each foot.

- Known hypersensitivity to botulinic toxin or its excipients

- Current treatment with aminosides

- Myasthenia

- Swallowing difficulties

- Respiratory disorders

- Past medical history of dysphagia or pneumopathy of inhalation

- Known allergy or contraindications to lidocaine, prilocaine, paracetamol or nitrous
oxide

- Pregnancy (positive pregnancy test (β-HCG) for women of childbearing age, performed
within the 2 days prior to the study. Breastfeeding.

- Contraception during 6 months from inclusion

- Mental or physical or judicial incapacity to fill the questionnaires

- Guardianship patients

- Skin infection on the soles at the time of the inclusion

- Skin lesions located on the soles, not related to LEBS (ie. post traumatic wound,
wart)

- Patient suffering from dishydrosis

- Botulinic toxin injections in the previous 6 months

- Inclusion in another study in the previous 2 months