Status:
UNKNOWN
Injections of Botulinic Toxin in Plantar Lesions of Localized Epidermolysis Bullosa Simplex
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Epidermolysis Bullosa Simplex
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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).
Detailed Description
Epidermolysis bullosa is a group of rare genetic diseases characterized by the occurrence of blisters and erosions due to skin fragility. There are 4 different subgroups, based on the location of the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03453632
Start Date
June 14 2018
End Date
December 1 2023
Last Update
August 23 2023
Active Locations (4)
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1
University Hospital Bordeaux
Bordeaux, France, 33000
2
University Hospital Nice
Nice, France, 06000
3
Saint-Louis Hospital - APHP
Paris, France, 75000
4
Hôpital Larrey - CHU Toulouse
Toulouse, France, 31059