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

Epidermolysis Bullosa Simplex Clinical Trial

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.

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03453632
Study type Interventional
Source University Hospital, Toulouse
Contact Juliette Mazereeuw-Hautier, MD
Phone 5 67 77 81 41
Email mazereeuw-hautier.j@chu-toulouse.fr
Status Recruiting
Phase Phase 2/Phase 3
Start date June 14, 2018
Completion date December 2023
View Details
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