Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT03453632
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03453632
Study Brief:
Protocol Section:
NCT03453632