Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00435682
Status:
COMPLETED
Last Update Posted:
2008-02-08
First Post:
2007-02-14
Brief Title:
To Study the Peripheral Effect of Botulinum Toxin-A Botox-A on Experimentally Induced Cutaneous Pain in Healthy Subjects
Sponsor:
Aalborg University
Organization:
Aalborg University
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a human trial to study the peripheral effect of therapeutic botulinum toxin botox-A The trial is performed on healthy normal males The study comprises of two parallel placebo-controlled double blinded studies
In experiment 1 intramuscular Botox will be given in corrugator one site and frontalis two sites muscles on one side and placebo to the other side Intradermal id capsaicin injection will be given to both sides between the two sites of frontalis injection horizontally Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to different stimulus modalities will be measured and mapped at specific time points using different cutaneous stimuli thermal electrical tactile pressure This will characterize which fibres and receptors are affected by Botox and will show if Botox have a unilateral effect peripheral or if it also affects the contralateral side central effect
In experiment 2 intradermal Botox will be given in corrugator one site and frontalis two sites muscles on one side and placebo to the other side Id capsaicin injection will be given to both sides between the two sites of frontalis injection horizontally Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to different stimulus modalities will be measured and mapped at specific time points using different cutaneous stimuli thermal electrical tactile pressure This will characterize which fibres and receptors are affected by Botox The effect of intradermal Botox will be compared to the results of experiment 1
The two experiments will show if the intramuscular Botox exerts its action via a leak of Botox from the muscle to the overlying skin
Antipruritic effects of Botox on histamine prick test and itch will also be assessed in parallel with the experiment 2 In this sub-experiment 5 Units of Botox will be injected intradermally in the middle of volar forearm The same volume of placebo will be injected into the other side Histamine prick test will induce itch and the effect of intradermal Botox will be assessed compared to the baseline Flare area and visual analogue scale VAS ratings will be measured
In experiment 1 intramuscular Botox will be given in corrugator one site and frontalis two sites muscles on one side and placebo to the other side Intradermal id capsaicin injection will be given to both sides between the two sites of frontalis injection horizontally Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to different stimulus modalities will be measured and mapped at specific time points using different cutaneous stimuli thermal electrical tactile pressure This will characterize which fibres and receptors are affected by Botox and will show if Botox have a unilateral effect peripheral or if it also affects the contralateral side central effect
In experiment 2 intradermal Botox will be given in corrugator one site and frontalis two sites muscles on one side and placebo to the other side Id capsaicin injection will be given to both sides between the two sites of frontalis injection horizontally Capsaicin-induced pain intensity and flare together with the area of hypersensitivity to different stimulus modalities will be measured and mapped at specific time points using different cutaneous stimuli thermal electrical tactile pressure This will characterize which fibres and receptors are affected by Botox The effect of intradermal Botox will be compared to the results of experiment 1
The two experiments will show if the intramuscular Botox exerts its action via a leak of Botox from the muscle to the overlying skin
Antipruritic effects of Botox on histamine prick test and itch will also be assessed in parallel with the experiment 2 In this sub-experiment 5 Units of Botox will be injected intradermally in the middle of volar forearm The same volume of placebo will be injected into the other side Histamine prick test will induce itch and the effect of intradermal Botox will be assessed compared to the baseline Flare area and visual analogue scale VAS ratings will be measured
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None