Healthy
Conditions
Keywords
Absorbing hygiene product, Skin sampling, Cytokines
Brief 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.
Interventions
OTHERHealthy volunteers
All subject belong to the same arm and ther is no intervention
Sponsors
Essity Hygiene and Health AB
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cytokine detection | 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). |
Countries
Sweden
Outcome results
None listed