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

• Register: ClinicalTrials.gov
• Last refreshed on: 4 September 2023
• Main ID: NCT03453632
• Date of registration: 06/02/2018
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Toulouse
• Public title: Injections of Botulinic Toxin in Plantar Lesions of Localized Epidermolysis Bullosa Simplex EBTox
• Scientific 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.
• Date of first enrolment: June 14, 2018
• Target sample size: 25
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03453632
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Juliette Mazereeuw-Hautier, MD
• Affiliation: University Hospital, Toulouse

• Name: Juliette Mazereeuw-Hautier, MD

Key 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 (ß-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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Epidermolysis Bullosa Simplex

Intervention(s)

Drug: Placebo

Drug: Botulinic toxin

Primary Outcome(s)

Global clinical improvement on each foot assessed by a blinded centralized independent reviewer using photographs, at M3 vs.baseline: IGA score (Improvement Global Assessment) assessed for each foot [Time Frame: at baseline vs month 3]

Secondary Outcome(s)

Efficacy assessment concerning the number of plantar lesions clinically observed by the investigator [Time Frame: at baseline, month 1, month 3 and month 6]

Global clinical improvement on each foot assessed by a blinded centralized independent reviewer using photographs: IGA score (Improvement Global Assessment) for each foot [Time Frame: at baseline vs month 6]

Immediate tolerance during injection : [Time Frame: Day 0]

Mid-term and long-term tolerance [Time Frame: Day 0, month 1, month 3 and month 6 and month 9]

Efficacy assessment by the patient himself, for each foot [Time Frame: at month 1, month 3, month 6 and month 9]

Efficacy assessment on each foot of the affected plantar skin surface (blisters, erosions, erythematous and edematous areas, crusts) [Time Frame: at baseline, month 1, month 3 and month 6]

Global clinical improvement on each foot assessed by the investigator: IGA score (Improvement Global Assessment) assessed for each foot. [Time Frame: at month1, month 3 and month 6 respectively vs baseline]

Plantar pain assessment by the patient himself, for each foot [Time Frame: at baseline, month 1, month 3 and month 6]

Secondary ID(s)

RC31/16/8917

2017-002332-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors