Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777383
Status:
UNKNOWN
Last Update Posted:
2021-03-02
First Post:
2021-02-22
Brief Title:
The Effects of Iontophoresed Vasoactive Drugs on Cutaneus Blood Flow
Sponsor:
University Hospital Linkoeping
Organization:
University Hospital Linkoeping
Study Overview
Official Title:
A Non-randomized Experimental Study of Optically Registered Pharmacodynamic Responses During Iontophoresis of Vasoactive Substances to the Skin of Healthy Volunteers
Status:
UNKNOWN
Status Verified Date:
2021-02
Last Known Status:
RECRUITING
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:
Jonto01
Brief Summary:
Many acute and chronical medical conditions such as shock sepsis diabetes hypertonia and cardiovascular disease are associated with a perturbated or lost ability of regulating the diameter of the blood vessels These changes in regulatory function can be seen especially in the smaller vessels in the body It is therefore clinically relevant to develop investigation models that can detect and quantify such changes at an early stage
Historically basic vascular function was investigated by mounting a section of a blood vessel on a tension sensor submerging it in a temperature controlled and buffered solution to which vasoactive substances were added This in vitro model has contributed substantially to our current knowledge of vascular pharmacology and function However using this method means that the vessel is removed from its natural environment and hence no longer influenced by systemic or local mediators for controlling vessel diameter
The present study aims to investigate the local changes in blood flow and concentration of red blood cells of the superficial vessels in the skin of the forearm of healthy volunteers in response to various vasoactive substances The purpose is to better understand how the regulation of diameter works in and to find a model that can give an early warning to when it does not function optimally
The vasoactive substances will be delivered through the skin to the vascular bed by a non-invasive method called iontophoresis An electrode chamber containing a solution of the substance to be studied is placed on the subjects skin by double adhesive tape The chamber comes with a transparent lid that prevents leakage and enables supervision of the effect on the underlying vasculature When a voltage is applied the charged drug molecules begin to move through the skin and interact with the vessels In the present study a total electrical dose of 12 millicoulomb mC is going to be used 600 seconds x 002 milliampere
The effect of the applied drug is measured using two non-contact optical measurement techniques
A better understanding of the pharmacology and regulation of blood vessels may lead to the developement of techniques that allow earlier detection of perturbations in vessel regulation and the onset of preventive medical treatment
Historically basic vascular function was investigated by mounting a section of a blood vessel on a tension sensor submerging it in a temperature controlled and buffered solution to which vasoactive substances were added This in vitro model has contributed substantially to our current knowledge of vascular pharmacology and function However using this method means that the vessel is removed from its natural environment and hence no longer influenced by systemic or local mediators for controlling vessel diameter
The present study aims to investigate the local changes in blood flow and concentration of red blood cells of the superficial vessels in the skin of the forearm of healthy volunteers in response to various vasoactive substances The purpose is to better understand how the regulation of diameter works in and to find a model that can give an early warning to when it does not function optimally
The vasoactive substances will be delivered through the skin to the vascular bed by a non-invasive method called iontophoresis An electrode chamber containing a solution of the substance to be studied is placed on the subjects skin by double adhesive tape The chamber comes with a transparent lid that prevents leakage and enables supervision of the effect on the underlying vasculature When a voltage is applied the charged drug molecules begin to move through the skin and interact with the vessels In the present study a total electrical dose of 12 millicoulomb mC is going to be used 600 seconds x 002 milliampere
The effect of the applied drug is measured using two non-contact optical measurement techniques
A better understanding of the pharmacology and regulation of blood vessels may lead to the developement of techniques that allow earlier detection of perturbations in vessel regulation and the onset of preventive medical treatment
Detailed Description:
A non-randomised study to investigate how 6 different vasoactive substances administrated in 5 different concentrations and with repeated administration affect the cutaneous superficial vessels The primary aim is to investigate dose-response mechanisms by use of two non-invasive optical measurement technologies
The substances are administrated by iontophoresis using a protocol with a current of 002 mA for 600 seconds at a total electrical charge of 12 mC Each drug is diluted using sterile water into five concentration 1 01 001 0001 and 00001 In the sixth chamber only sterile water will be administrated
An electrode chamber per concentration is attached to the skin of each subjects forearm and each concentration is administrated three times
Only one substance at a time will be administrated
The substances used are
Acetylcholine - vasodilator Miochol-E 10mgml Bausch and Lomb
Noradrenaline - vasoconstrictor Noradrenaline 10mgml Pfizer
Phenylephrine - vasoconstrictor Phenylephrine 10mgml Unimedic
Atropine - anticholinergic Atropine 10mgml Bausch and Lomb
Neostigmine - acetylcholineesterase inhibitor Neostigmine 10mgml Unimedic Pharma
Dilutor sterile water Sterile water 100 ml Braun
Iontophoresis protocol 002 mA x 600 seconds x 3 repetitions per drug concentration and localization Each iontophoretic pulse is preceded by a baseline registration and followed by a 30 minutes wash-outrecovery period
Vascular effects are continuously non-invasively and indirectly measured using tissue viability imaging TiVi cross-polarized diffuse reflectance spectroscopy and multi-exposure laser speckle contrast imaging MELSCI The optical measurement modalities are placed at a distance of approximately 30 cm above the skin surface so that the vascular responses can be measured in three electrode chambers simultaneously for the duration of the test 120 minutes
TiVi settings - 1 imageminute at 6000 x 4000 pixels MELSCI settings - 156 framessecond at 1024 x 1000 pixels
The substances are administrated by iontophoresis using a protocol with a current of 002 mA for 600 seconds at a total electrical charge of 12 mC Each drug is diluted using sterile water into five concentration 1 01 001 0001 and 00001 In the sixth chamber only sterile water will be administrated
An electrode chamber per concentration is attached to the skin of each subjects forearm and each concentration is administrated three times
Only one substance at a time will be administrated
The substances used are
Acetylcholine - vasodilator Miochol-E 10mgml Bausch and Lomb
Noradrenaline - vasoconstrictor Noradrenaline 10mgml Pfizer
Phenylephrine - vasoconstrictor Phenylephrine 10mgml Unimedic
Atropine - anticholinergic Atropine 10mgml Bausch and Lomb
Neostigmine - acetylcholineesterase inhibitor Neostigmine 10mgml Unimedic Pharma
Dilutor sterile water Sterile water 100 ml Braun
Iontophoresis protocol 002 mA x 600 seconds x 3 repetitions per drug concentration and localization Each iontophoretic pulse is preceded by a baseline registration and followed by a 30 minutes wash-outrecovery period
Vascular effects are continuously non-invasively and indirectly measured using tissue viability imaging TiVi cross-polarized diffuse reflectance spectroscopy and multi-exposure laser speckle contrast imaging MELSCI The optical measurement modalities are placed at a distance of approximately 30 cm above the skin surface so that the vascular responses can be measured in three electrode chambers simultaneously for the duration of the test 120 minutes
TiVi settings - 1 imageminute at 6000 x 4000 pixels MELSCI settings - 156 framessecond at 1024 x 1000 pixels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None