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COMPLETED
NCT03453632
PHASE2/PHASE3

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

Sponsor: University Hospital, Toulouse

View on ClinicalTrials.gov

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).

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2018-06-14

Completion Date

2025-01-21

Last Updated

2026-09-21

Healthy Volunteers

No

Interventions

DRUG

Botulinic toxin

Clinical photographs of the soles Standardized anesthesia protocol (lidocaine, prilocaine on soles, cryo-spray, oral administration of paracetamol and only if necessary oxycodone and hydroxyzine). Cleaning and antiseptic on the soles Injections of botulinic toxin (200 UI) on right or left foot

DRUG

Placebo

Clinical photographs of the soles Standardized anesthesia protocol (lidocaine, prilocaine on soles, cryo-spray, oral administration of paracetamol and only if necessary oxycodone and hydroxyzine). Cleaning and antiseptic on the soles Injections of physiological serum (200 UI) on right or left foot

Locations (4)

University Hospital Bordeaux

Bordeaux, France

University Hospital Nice

Nice, France

Saint-Louis Hospital - APHP

Paris, France

Hôpital Larrey - CHU Toulouse

Toulouse, France