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

NCT07117747 | Completed

• 1 other identifier: C3351
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Absorbing hygiene product; Skin sampling; Cytokines

Outcome Measures

Primary Outcomes (1)

• Cytokine detection

  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).

  1-2 months

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Single arm study

Other: Healthy volunteers

Interventions

Healthy volunteers OTHER

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

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Essity Hygiene and Health AB: lead

Study Sites (1)

Essity Study Site

Mölndal, Sweden

Location

Study Officials

• Warangkana Lohcharoenkal, PhD

  Essity Hygiene and Health AB

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: March 1, 2025
• Primary Completion: April 29, 2025
• Study Completion: July 22, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)