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Botulinumtoxin A Treatment in Epidermolysis Bullosa Simplex and Pachyonychia Congenita

NCT00936533 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-03-09

No results posted yet for this study

Summary

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).

Conditions

  • Epidermolysis Bullosa Simplex

Interventions

DRUG

Dysport® (Botulinumtoxin A (Btx A))

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.

DRUG

Placebo

Placebo preparation without active compound, administered as the active drug.

Sponsors & Collaborators

  • Uppsala University

    lead OTHER

Principal Investigators

  • Carl Swartling · Uppsala University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00936533 on ClinicalTrials.gov