Could botox stop blisters on the soles of people with a rare skin condition?
NCT ID NCT03453632
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing whether injections of botulinum toxin into the soles of the feet can reduce blistering in people with localized epidermolysis bullosa simplex, a rare skin condition that causes painful foot blisters. The trial enrolls 18 people with similar blisters on both feet. Each participant receives botulinum toxin in one foot and a placebo injection in the other, and independent reviewers compare clinical photographs over three months to see if the treated foot improves more.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- botulinum toxin type A injections into the soles of the feet
- What this could lead to
- If it works, botulinum toxin injections could become a way to reduce painful foot blisters for people with localized epidermolysis bullosa simplex, possibly by lowering sweating on the soles.
- What could go wrong
- This is a small trial of 18 people, so results may not hold up in larger groups. Injections into sore feet carry risks of pain, bruising, or temporary weakness, and the treatment may not reduce blisters at all.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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18 people
The number who actually took part.
- Started
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Jun 2018
- Finished
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Jan 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpital Larrey - CHU Toulouse
Toulouse, 31059, France
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Saint-Louis Hospital - APHP
Paris, 75000, France
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University Hospital Bordeaux
Bordeaux, 33000, France
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University Hospital Nice
Nice, 06000, France
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