Injections of Botulinic Toxin in Plantar Lesions of Localized Epidermolysis Bullosa Simplex (NCT03453632) | Clinical Trial Compass
UnknownPhase 2/3
Injections of Botulinic Toxin in Plantar Lesions of Localized Epidermolysis Bullosa Simplex
France25 participantsStarted 2018-06-14
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Global clinical improvement on each foot assessed by a blinded centralized independent reviewer using photographs, at M3 vs.baseline: IGA score (Improvement Global Assessment) assessed for each foot