NCT07117747

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Essity Hygiene and Health AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Healthy volunteers	All subject belong to the same arm and ther is no intervention

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-04-29
• Completion: 2025-07-22
• First posted: 2025-08-12
• Last updated: 2025-08-12

Locations

1 site across 1 country: Sweden