A Phase 2 interventional study of Dysport® (Botulinumtoxin A (Btx A)) and Placebo in Epidermolysis Bullosa Simplex, sponsored by Uppsala University. Status unknown at 1 site in Sweden. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2011-03-09.
Sponsored by Uppsala University · Phase 2, Interventional, and Treatment
This study evaluates the clinical effect of foot injection of the bacteria protein Botulinum toxin A on plantar pain in patients with EBS (epidermolysis bullosa simplex) or PC (pachyonychia congenita).
Epidermolysis bullosa simplex (EBS) is the most common subtype of epidermolysis bullosa and mutations in keratin genes (KRT 5/14) are responsible for this condition. Painful blisters and keratoderma of the feet are common and the blisters in EBS typically get worse in the summer due to sweating and increased environmental heat. Since 2010, also the related condition pachyonychia congenita (PC) is included in the study. The primary objective of the study is to evaluate the clinical effect of Botulinum toxin A (Dysport®), injected in the foot, on plantar pain in patients with EBS or PC. Quality of life, pain in feet, effect duration, plantar sweating and safety of the treatment will also be studied.
22 studies on the registry are indexed under Epidermolysis Bullosa Simplex; 5 are open to participants now.
This study's planned enrollment of 40 is above the median of 18 across 19 interventional studies indexed under Epidermolysis Bullosa Simplex.
Browse Epidermolysis Bullosa Simplex studies →Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
Single injection in patients´ soles with Btx A in one foot and sodium chloride in the other, with the possibility of a second injection after 12 weeks. The drug will be given in general anaesthesia after curettage of the focal hyperkeratoses. Only the areas with focal hyperkeratoses will be injected with 50 ul per injection.The active drug Btx A (Dysport®, solution for injection) has a concentration of 100 U/ml, and the maximum dose is 300 U per foot.
Also known as: Dysport®
Placebo preparation without active compound, administered as the active drug.
Also known as: Dysport Placebo
Determination of the difference between treated and untreated foot in change of pressure (measured by manometry) to reach unbearable pain, VAS=8, from baseline to 5 week after injection.
Time frame: 5 weeks
Quality of life using a questionnaire (DLQI)
Time frame: 12 or 17 weeks
Pain in feet using a questionnaire (VAS)
Time frame: 5, 12 (and 17) weeks
Effect duration measured with manometry (same as primary end-point but measured at week 12)
Time frame: 12 weeks
Safety by recording of reported adverse events (AE) by the patient at the clinic visits
Time frame: 5, 12 (and 17) weeks
Foot-sweating using iodine-starch imprints before and after injections
Time frame: 0 weeks
This study is status unknown, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A
Epidermolysis Bullosa Simplex →