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

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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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Essity Study Site

Mölndal, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healthy Volunteers

Other

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

Primary outcomes

Cytokine detection

Time frame: 1-2 months

the detection of cytokines obtained by the different extraction solvents and sampling methods. ELISA complemented with the Micro BCA Protein Assay were used to quantify the cytokine recovery (in pg/ug total soluble protein).

Sponsors and collaborators

Lead sponsor

Essity Hygiene and Health AB

Industry

Registry information

Official study title

Non-invasive Skin Sampling: Optimization of Sample Collection and Extraction. Enhancing Cytokine Recovery by the Modification of Extraction Solvents and the Use of Alternative Sampling Methods

Acronym: SPECIMEN

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Aug 12, 2025
Registry last updated: Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed