Last updated: August 22, 2023
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting
Phase
2/3
Condition
Pemphigus Vulgaris (Pv)
Epidermolysis Bullosa
Treatment
Placebo
Botulinic toxin
Clinical Study ID
NCT03453632
RC31/16/8917
2017-002332-16
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Diagnosis of LEBS based on clinical symptoms and in some cases histological ormolecular 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
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 nitrousoxide
- Pregnancy (positive pregnancy test (β-HCG) for women of childbearing age, performedwithin 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
Study Design
Total Participants: 25
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2/3
Study Start date:
June 14, 2018
Estimated Completion Date:
December 31, 2023
Study Description
Connect with a study center
University Hospital Bordeaux
Bordeaux, 33000
FranceActive - Recruiting
University Hospital Nice
Nice, 06000
FranceActive - Recruiting
Saint-Louis Hospital - APHP
Paris, 75000
FranceActive - Recruiting
Hôpital Larrey - CHU Toulouse
Toulouse, 31059
FranceActive - Recruiting
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