Skip to content

Validation of the Clinical Value of Interstitial Fluid Biomarkers in Skin

Validation of the Clinical Value of Interstitial Fluid Biomarkers in Skin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1032230545
Enrollment
60
Registered
2024-01-09
Start date
2024-05-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 (cutaneousintersti

Sponsors

Nakamura Kenjiro
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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.

Design outcomes

Primary

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

Secondary

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

Contacts

Public ContactKasumi Matsui

I'cros Co., Ltd.

tp-ns-crprt001-01_ircos@iromgp.com+81-92-406-8278

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026