Perfusie gerelateerde stoornissen N.A.
Conditions
Interventions
To induce local vasoconstriction and vasodilatation, brimonidine cream and
capsaicin cream will be applied on the forearm of the volunteers.
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Healthy volunteers, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, - Body mass index (BMI) between 18 and 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
Exclusion criteria
Exclusion criteria: - History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder. - Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg. - Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary supplements within 21 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day). Other exceptions will only be made if the rationale is discussed and clearly documented between the Investigator and the sponsor. - Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study. - Smokers as defined by any of the following criteria:Reported smoking of cigarettes within 12 months prior to screening; occasionally a cigarette is allowed, but not within 24 hours of the measurements. - Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Feasibility and applicability is achieved as the researchers were able to produce hyperspectral images, which were available to analysis without too much noise caused by an unstandardized measurements. 2) Reproducibility is measured by repeating the measurements on two different days in the same study population. Therefore, the following parameters will be evaluated by LSCI: - Basal blood flow - Blood blow upon occlusion-reperfusion brachial artery - Blood flow after applying capsaicin-based cream and brimonidine | — |
Secondary
| Measure | Time frame |
|---|---|
| Hyperspectral measures of: 1. basal blood flow / oximetry 2. blood flow /oximetry upon occlusion-reperfusion brachial artery 3. Blood flow / oximetry after applying capsaicin-based cream 4. Blood flow/ oximetry after applying brimonidine The endpoint of the study is if a selection of spectral bands, specific for tissue perfusion and oxygenation, which will be selected after data processing of above mentioned measurements, could be achieved. | — |
Countries
Netherlands
Outcome results
None listed