The Effects of Iontophoresed Vasoactive Drugs on Cutaneus Blood Flow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 subject's 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 0.02 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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Role of Acetylcholine in Blood Flow Regulation in Healthy Adults: Effects of Age and Exercise Training

NCT03972683

Vasoconstriction Vasodilation

WITHDRAWN EARLY_PHASE1

Physiologic Effect of Topical Nitroglycerin on Microcirculation Capacity in Patients With Circulatory Shock.

NCT05102734

Circulatory Shock Cardiovascular Shock

COMPLETED

The Haem and Nitrite Study - The Effects of Haemoglobin NO-blockade on Nitrite-induced Forearm Vessel Dilatation

NCT03077763

Healthy Volunteers

UNKNOWN PHASE1

Effects of Pyruvate in Patients With Cardiogenic Shock and Intra-aortic Balloon Counterpulsation

NCT00604331

Shock, Cardiogenic Heart Failure Acute Myocardial Infarction

COMPLETED PHASE2

Norepinephrine Administration Through a Midline Catheter in an Intermediate Care Unit

NCT06121115

Septic Shock Norepinephrine Adverse Reaction Hypotension and Shock

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 0.02 mA for 600 seconds, at a total electrical charge of 12 mC. Each drug is diluted using sterile water into five concentration (1%, 0.1%, 0.01%, 0.001% and 0.0001%). In the sixth chamber only sterile water will be administrated.

An electrode chamber per concentration is attached to the skin of each subject's 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, 10mg/ml, Bausch and Lomb)
* Noradrenaline - vasoconstrictor (Noradrenaline, 10mg/ml, Pfizer)
* Phenylephrine - vasoconstrictor (Phenylephrine, 10mg/ml, Unimedic)
* Atropine - anticholinergic (Atropine, 10mg/ml, Bausch and Lomb)
* Neostigmine - acetylcholineesterase inhibitor (Neostigmine, 10mg/ml, Unimedic Pharma)
* Dilutor: sterile water (Sterile water, 100 ml, Braun)

Iontophoresis protocol: 0.02 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-out/recovery 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 image/minute at 6000 x 4000 pixels MELSCI settings - 15.6 frames/second at 1024 x 1000 pixels

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Vascular Diseases

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Iontophoresis of vasoactive substances in 5 different concentrations. Each concentration is administrated 3 times to the same localisation.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vascular effects of iontophoresed vasoactive substances

Iontophoretically administered vasoactive substances in five concentrations (1%,0.1%,0.01%,0.001%, 0.0001%) dissolved in sterile water. Each concentration of the drug is separately administered using a electrical charge of 12 millicoulomb (mC) (600 seconds x 0.02 milliampere) for 3 repeated pulses (total electrical charge 36 mC). Each iontophoresis pulse is separated by a 30 minute wash-out period.

Vasoactive substances:

* Miochol-E (Acetylcholine),10 mg/ml, Bausch \& Lomb
* Methacholine chloride, 100 mg/ml, APL
* Norepinephrine, 1 mg/ml, Pfizer
* Phenylephrine, 10 mg/ml, Unimedic
* Atropine, 10 mg/ml, Bausch \& Lomb
* Neostigmine, 2.5 mg/ml, Unimedic Pharma
* Sterile water, 100 ml, Braun

Group Type EXPERIMENTAL

Acetylcholine

Intervention Type DRUG

Iontophoretic administration of 5 different concentrations of acetylcholine

Norepinephrine

Intervention Type DRUG

Iontophoretic administration of 5 different concentrations of norepinephrine

Phenylephrine

Intervention Type DRUG

Iontophoretic administration of 5 different concentrations of phenylephrine

Atropine

Intervention Type DRUG

Iontophoretic administration of 5 different concentrations of atropine

Neostigmine

Intervention Type DRUG

Iontophoretic administration of 5 different concentrations of neostigmine

Sterile water

Intervention Type DRUG

Iontophoretic administration of sterile water

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acetylcholine

Iontophoretic administration of 5 different concentrations of acetylcholine

Intervention Type DRUG

Norepinephrine

Iontophoretic administration of 5 different concentrations of norepinephrine

Intervention Type DRUG

Phenylephrine

Iontophoretic administration of 5 different concentrations of phenylephrine

Intervention Type DRUG

Atropine

Iontophoretic administration of 5 different concentrations of atropine

Intervention Type DRUG

Neostigmine

Iontophoretic administration of 5 different concentrations of neostigmine

Intervention Type DRUG

Sterile water

Iontophoretic administration of sterile water

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Miochol-E, 10mg/ml, Bausch and Lomb Norepinephrine, 1 mg/ml, Pfizer Phenylephrine, 10 mg/ml, Unimedic Atropine, 10 mg/ml, Bausch & Lomb Neostigmine, 2.5 mg/ml, Unimedic Pharma Sterile water, 100 ml, Braun

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Healthy
* No ongoing medication
* No skin disease or other skin afflictions
* Informed, voluntary participation

Exclusion Criteria

* Ongoing medication (contraceptives excluded)
* Hypertonia, skin disease or skin afflictions, cardiovascular disease, pregnancy
* Damaged skin, bruises, scar tissue or tattoos on the skin of the forearms
* Smoking (6 months prior to study onset, or more than 100 cigarettes in life)
* Snus (6 months prior to study onset)
* Use of nicotine products (gum, patch, et cetera) 6 months prior to study onset
* Blood pressure above 140/90
* Coffee, tea, alcohol or strenuous physical activity on the day of the study
* Not fasting for 2 hours prior onset of the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes