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

Phase 1

Active, not recruiting

• 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.

• Registration Number: EUCTR2004-005194-27-AT
• Lead Sponsor: Department of Neurology, Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-25
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 6

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 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
study day
·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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objectives of the present study are to demonstrate potential antiinflammatory, antihyperalgesic on the peripheral and/or central level effects of Botulinum toxin a (Dyport). ;Secondary Objective: Furthermore, we want to explore a potential mitigation of BoNT/A by UV-B irradiation and /or the ensuing sunburn reaction of the skin.;Primary end point(s): The main outcome variables will be: <br>1.for peripheral antihyperalgesic effects: heat pain perception threshold<br> (HPPT)<br>2.for central antihyperalgesic effects: area of secondary hyperalgesia<br>3.for anti-inflammatory effects: superficial skin blood flow in the sunburn<br> spots, as assessed with laser Doppler interferometry (LDI)<br>4.for BoNT/A activity after UV-B irradiation and sunburn: area of anhidrosis<br> as assessed with the iondine starch test (Minor Test).<br>