Injections of Botulinic Toxin in Plantar Lesions of Localized Epidermolysis Bullosa Simplex

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

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).

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

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 skin cleavage area. The most frequent subgroup is the simplex form, consisting predominantly of the localized form (localized epidermolysis bullosa simplex: LEBS). The incidence of LEBS was estimated at between 1/318.000 and 1/35.000. The disease starts early in infancy by the occurrence of blisters and erosions located on soles, secondary to frictions during the walk. The phenomenon is worsened by heat and sudation. LEBS is due to mutations in keratin genes. Life expectancy in LEBS is normal but the quality of life is significantly impaired due to permanent skin pain and limitation of everyday activities (walking, sports). There is no effective or curative treatment. Patients must limit the frictions, protect the skin and use plasters in case of skin lesions.

Botulinic toxin has an agreement for the treatment of axillary hyperhidrosis and has been shown to be also effective on palms and soles. The efficacy of botulinic toxin in plantar lesions of LEBS has been reported in the literature (one case report and a short retrospective series of 6 patients) but there is no proper study.

Connect with a study center

  • University Hospital Bordeaux

    Bordeaux, 33000
    France

    Active - Recruiting

  • University Hospital Nice

    Nice, 06000
    France

    Active - Recruiting

  • Saint-Louis Hospital - APHP

    Paris, 75000
    France

    Active - Recruiting

  • Hôpital Larrey - CHU Toulouse

    Toulouse, 31059
    France

    Active - Recruiting

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