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Clinical Trials/EUCTR2004-005194-27-AT
EUCTR2004-005194-27-AT
Active, not recruiting
Phase 1

Anti-inflammatory and/or antinociceptive effects of botulinum toxin A in an experimental inflammatory human skin pain model: a randomised, double blinded, placebo controlled study - UV-B and BoNT

Department of Neurology, Medical University of Vienna0 sites6 target enrollmentFebruary 25, 2008
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Conditionsnot applicableIn this trial a potential antinociceptive potency af the IMP (Dysport) will be testet i9n a human inflammatory pain model. The present study will only include heathy volunteers.

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
not applicableIn this trial a potential antinociceptive potency af the IMP (Dysport) will be testet i9n a human inflammatory pain model. The present study will only include heathy volunteers.
Sponsor
Department of Neurology, Medical University of Vienna
Enrollment
6
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
February 25, 2008
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Department of Neurology, Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria
  • •·Men or women, aged between 19 and 75 years
  • •·Body mass index between 15th and 85th percentile
  • •·Normal findings in the medical history, physical and neurological
  • •examination
  • •·without dermatological alterations on the upper legs in the area of
  • •measurement
  • •·no exposure to Botulinum toxin for at least one year
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:

Exclusion Criteria

  • •Any of the following will exclude a subject from the study:
  • •·Previously exposed to Botulinum toxin
  • •·Regular use of anticholinergic medication especially anhidrotic drugs,
  • •aminoglycosid antibiotics, abuse of alcoholic beverages
  • •·Participation in a clinical trial in the 2 weeks preceding the study
  • •·Symptoms of a clinically relevant illness in the 4 weeks before the first
  • •·Acute skin diseases on the relevant areas
  • •·Contraindications to botulinum toxin A: pregnancy, breast feeding, known
  • •allergy or hypersensitivity, myasthenia gravis or Eaton\-Lambert\-syndrom,
  • •myopathies and myotonias.

Outcomes

Primary Outcomes

Not specified

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