Botulinic toxin injections for treating blisters in localized epidermolysis bullosa simplex
Evaluation of the Efficacy of Injections of Botulinic Toxin in Plantar Lesions of Patients Suffering From Localized Epidermolysis Bullosa Simplex : Double Blind Randomized Controlled Study.
This study is testing whether botulinic toxin injections can help reduce blisters in people with localized epidermolysis bullosa simplex by limiting sweating in affected areas.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 4 sites (Bordeaux and 3 other locations) |
| Trial ID | NCT03453632 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of botulinic toxin injections to reduce blister formation in patients with localized epidermolysis bullosa simplex (LEBS). The hypothesis is that by inhibiting sweating in the affected areas, the occurrence of blisters can be limited. The study will involve patients with specific skin lesions on their feet and will compare the effects of botulinic toxin against a placebo. The trial aims to provide a potential new treatment option for this rare skin condition, which currently lacks effective therapies.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with localized epidermolysis bullosa simplex who have multiple skin lesions on their feet.
Not a fit: Patients with only one leg, significant respiratory disorders, or known allergies to botulinic toxin or its components may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from localized epidermolysis bullosa simplex by reducing blister formation and associated pain.
How similar studies have performed: While there have been limited reports on the efficacy of botulinic toxin for this condition, this study represents a more structured investigation into its potential benefits.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux and 3 other locations
- University Hospital Bordeaux — Bordeaux, France (Recruiting)
- University Hospital Nice — Nice, France (Recruiting)
- Saint-Louis Hospital - APHP — Paris, France (Recruiting)
- Hôpital Larrey - CHU Toulouse — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Juliette Mazereeuw-Hautier, MD — University Hospital, Toulouse
- Study coordinator: Juliette Mazereeuw-Hautier, MD
- Email: mazereeuw-hautier.j@chu-toulouse.fr
- Phone: 5 67 77 81 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.