Non-invasive Sampling Method for Skin Test: Optimization of Sample Collection and Extraction

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-07-22

Brief Summary

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When absorbent hygiene products-such as panty liners, sanitary pads, incontinence products, or wound care items-are used over extended periods, they can sometimes have negative effects on the skin. The aim of the current study is to investigate the best way to measure the amount of cytokines on the skin through a non-invasive method.

Cytokines are small proteins that act as signaling molecules in the immune system and regulate inflammation and the body's response to infections. Because inflammatory markers often appear in very low concentrations in skin surface samples, it is essential to optimize both collection and extraction methods to overcome this limitation.

The researchers want to evaluate different sampling and extraction techniques to measure the skin's inflammatory response. The effectiveness assessment involves determining how well these methods can detect and analyze inflammatory markers. This includes ensuring the sampling methods are non-invasive yet sensitive enough to detect subtle changes in skin inflammation. Furthermore, the extraction methods must efficiently isolate relevant biomarkers to provide reliable data on the skin's response to the products.

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Detailed Description

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The aim of this project was to refine a non-invasive skin sampling technique, enhancing cytokine recovery by optimizing both the sample collection method (tape stripping or swabbing) and the cytokine extraction solvent (including buffer type, detergent, and detergent concentration). The analytes of interest were the following five cytokines: IL-1α, IL-1RA, IL-6, IL-8, and TNF-α, which are signaling molecules in the immune system and important inflammatory biomarkers. ELISA was used for quantitative analysis.

Tape stripping and swabbing are two non-invasive skin sampling methods. For tape stripping, sample collection and extraction have been performed using D-Squame tape and an extraction buffer reported in relevant publications. Expanding the list of detectable cytokines allows for more accurate evaluations of skin condition.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Samples are taken from the forearms of healthy individuals at two visits and the amount of cytokines that can be retrieved from the samples re extracted using various methods in order to optimize the protocol.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Single arm study

Group Type EXPERIMENTAL

Healthy volunteers

Intervention Type OTHER

All subject belong to the same arm and ther is no intervention

Interventions

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Healthy volunteers

All subject belong to the same arm and ther is no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Sex: men/women
* Age: \>18 years
* Subjects with full legal competence
* Subjects who have provided a signed informed consent and willing to come to the scheduled visit at the test site

Exclusion Criteria

* Subjects that have participated in any skin test that could cause damage to the skin barrier during the last 2 weeks
* Subjects that have participated in any skin test that could cause damage to the skin barrier during the last 2 weeks
* Subjects with known sensitivity or allergy to adhesives and nylon
* Have immunodeficiency, taking any anti-inflammatory medication or having any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator
* Subjects with hairy forearms
* Subjects with active skin diseases on the forearms

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes