Injections of Botulinic Toxin in Plantar Lesions of Localized Epidermolysis Bullosa Simplex

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Toulouse
• Treatments: abobotulinumtoxinA

Criteria

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

Exclusion Criteria:

• 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