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

Essity

Status

Completed

Conditions

Healthy

Treatments

Other: Healthy volunteers

Study type

Interventional

Funder types

Industry

Identifiers

NCT07117747

C3351

Details and patient eligibility

About

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.

Full description

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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