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CompletedPhase 2/3

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

Key facts

Who runs it
University Hospital, Toulouse
Where
France4 sites in 1 countryChoose a country to see its sites
Status
Completed
Phase
Phase 2/3
People taking part
18 people enrolled
Started
14 Jun 2018
Ended
21 Jan 2025
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Botulinic toxin
  • Placebo
Record updated
21 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 23 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current treatment with aminosides
  • Pregnancy (positive pregnancy test (β-HCG) for women of childbearing age, performed within the 2 days prior to the study. Breastfeeding
  • Botulinic toxin injections in the previous 6 months
  • Inclusion in another study in the previous 2 months
  • Known hypersensitivity to botulinic toxin or its excipients
  • Respiratory disorders
  • Past medical history of dysphagia or pneumopathy of inhalation
  • Known allergy or contraindications to lidocaine, prilocaine, paracetamol or nitrous oxide
  • Skin infection on the soles at the time of the inclusion
  • Patients with only one leg and a different number of toes on each foot
  • Myasthenia
  • Swallowing difficulties
  • Contraception during 6 months from inclusion
  • Mental or physical or judicial incapacity to fill the questionnaires
  • Guardianship patients
  • Skin lesions located on the soles, not related to LEBS (ie. post traumatic wound, wart)
  • Patient suffering from dishydrosis

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Botulinic toxinTreatment being tested

    Injections of botulinic toxin (Dysport®, Allergan) 200 UI

  • PlaceboPlacebo, for comparison

    Injections of physiological serum

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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.
Record updated
21 September 2026