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Validation of the Clinical Value of Interstitial Fluid Biomarkers in Skin

Validation of the Clinical Value of Interstitial Fluid Biomarkers in Skin

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Patient group (individuals with abnormal biomarker values specific to thyroid, cardiovascular, or respiratory diseases) and healthy adult group.

Subjects were selected based on evaluation in accordance with the inclusion and exclusion criteria of the study. Skin interstitial fluid collection was conducted for 4 cases in the healthy adult group and 8 cases in the patient group.

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Skin interstitial fluid was collected from both the healthy adult group and the patient group, and biomarker analysis was conducted, allowing identifying differences in the measured values.

Data were obtained on the biomarker concentrations in skin interstitial fluid for both the healthy adult group and the patient group, as well as in the differences between biomarker levels in skin interstitial fluid and blood.

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https://jrct.mhlw.go.jp/latest-detail/jRCT1032230545

Nakamura Kenjiro

Tenjin Sogo Clinic

1-22-20-701 Imaizumi, Chuo-ku, Fukuoka, Fukuoka Ken, Japan

tsc@smile.ocn.ne.jp

Matsui Kasumi

I'cros Co., Ltd.

1-1-1 Akurosufukuoka, Tenjin, Fukuoka Shi Chuo Ku, Fukuoka Ken, Japan

+81-92-406-8278

tp-ns-crprt001-01_ircos@iromgp.com

Complete

Jan. 09, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

diagnostic purpose

(1)Thyroid, circulatory, or respiratory disease such as who expected to show abnormal BM values specific to each of the disease mentioned or healthy adults.
(2)Patients who are at least 18 years old and less than 70 years old at the time of consent.
(3)(Healthy adult group only) Body Mass Index between 18.5 and 25.0.
(4)Patients who can obtain document consent with their own will before any study related procedure.

(1) Those who are unable to undergo blood tests.
(2) Persons with obvious skin abnormalities (abnormal pigmentation, swelling, wounds, etc.) at the site of interstitial fluid collection
(3) Patients who have received an injectable medication or vaccination within 1 week.
(4) (Healthy adult group only) Those who are allergic to inhaled allergens (pollen, house dust, etc.)
(5) (Healthy adult group only) Those with allergies to food, drugs, metals, etc., and have confirmed exposure to the relevant allergens within 1 week.
(6) (Healthy adult group only) Those who have suffered a traumatic injury or received invasive treatment within 1 week.
(7) (Healthy adult group only) Persons who have contracted an infectious disease within 3 weeks
(8) Persons with hypersensitivity to raw materials (aluminum alloy and polypropylene) used in the research equipment.
(9) Other persons who are judged to be ineligible by the principal investigators or research assistants.

Both

Persons expected to show abnormal BM (thyroid, circulatory, or respiratory disease),healthy adults.

Blisters formed on the bilateral forearms or thighs using the Negative Pressure Cutaneous Suction System [NP-4] are punctured with a syringe and needle to collect the fluid contents (cutaneousinterstitial fluid) and the BMs measured.

The difference between the skin interstitial fluid BMs collected from patients with each disease with the skin interstitial fluid BMs collected from healthy adults.

The difference between skin interstitial fluid BM measurements and blood BM measurements

+81-3-5213-0028

Nov. 21, 2023

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