Reducing Skin Surface PH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters

Not Applicable

Completed

• Conditions: Incontinence-associated Dermatitis
• Interventions: Other: Test patches

• Registration Number: NCT06363786
• Lead Sponsor: Essity Hygiene and Health AB

Brief Summary

The main aim of this exploratory research study is to investigate how exposure to a material with low pH affects the skin microbiome and skin parameters. This investigation involves an experimental setup in which application of test patches with lowered pH levels or control patches without lowered pH are used. The test patches are applied on healthy adult volunteers. About 20 subjects are planned for the study. The skin microbiome preservation and diversity will be addressed employing Molecular Sequencing and quantitative polymerase chain reaction (qPCR). In addition, skin pH, composition and hydration will be measured with various methods, e.g., AquaFlux, Moisture Meter, TEWL and Confocal Raman spectroscopy. The study will span three consecutive days in total. Each participant will be provided with four patches on each forearm: two patches will be applied to each dorsal forearm and two on each volar forearm. The first day will be for study inclusion and application of patches. In day two the patches will be changed and on day three measurements for pH, TEWL, skin hydration, Raman and tape stripping will be conducted and sampling for Molecular Sequencing and qPCR measurements will be done. There is no formal hypothesis in the study but our idea is that utilizing patches with a lower pH could maintain the diversity and richness of the natural skin microbiome while retaining and even enhancing key skin barrier parameters. A descriptive analysis will be conducted for all measurements with appropriate statistical tests on 5% level for variables. In addition to descriptive data analysis statistics, Clinical Microbiomics and Bio-Me Microbiome Profiling will employ various statistical methods, such as paired Mann-Whitney U tests. The Benjamini-Hochberg (BH) method to control the false discovery rate (FDR) will be employed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-12
• Study Start: 2024-04-15
• Primary Completion: 2024-05-30
• Study Completion: 2024-08-30
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Signed Informed Consent Form
2. Male and female ≥18 and ≤80 years.
3. Willingness and ability to comply with study procedures, visit schedules, and requirements.
4. Intact skin on the forearms without any signs of irritation.
5. Agree not to shower or use cosmetic products on the arms the day before visit 1 and during the study period.
6. Agree not to engage in intense physical activity throughout the study period.

Exclusion Criteria

1. Have any known allergies or intolerances to one or several components of the absorbing incontinence/menstrual products.
2. Have any known allergies or intolerances to one or several ingredients in cosmetic products.
3. Have an ongoing skin irritation/infection on the forearms.
4. Have any skin conditions such as psoriasis and eczema.
5. Have any tattoos on the forearms.
6. Suffer from excessive sweating, hyperhidrosis.
7. Have immunodeficiency or any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
8. Have an alcohol and/or drug dependency.
9. Have had active sunbathing on arms latest 2 weeks prior to study.
10. Have used tanning or bleaching products on arms at least 1 month before the study starts.
11. Have performed hair removal on the arms 1 month prior to the study.
12. Are pregnant or nursing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test patches	Test patches	Application of test patches. Each subject wear both low pH formula patches (intervention) and control patches without formula.

Primary Outcome Measures

Name	Time	Method
Changes in skin microbiome diversity as measured by qPCR	2 days	qPCR is employed to analyse and quantify specific microbial species or groups. Skin under the test and control patches are compared.
Changes in skin microbiome as measured by molecular sequencing	2 days	Molecular sequencing is used to provide taxonomic insight and overview of microbial diversity on the skin. Skin under the test and control patches are compared.
Skin surface pH	2 days	The change in skin surface pH under the test and control patches are compared.

Secondary Outcome Measures

Name	Time	Method
Change in Skin water profile	2 days	As measured Confocal raman microspectrometry. The water content of skin at different depths is measured and compared for the skin under test and control patches.
Change in Trans Epidermal Water loss	2 days	As measured by Dermalab instrument. Transepidermal water loss (TEWL) as measured under the test and control patches.
Change in skin hydration	2 days	Skin hydration (SH) as measured with moisture meter instrument under the test and control patches.
Presence of low pH formula on the skin	2 days	The extent on formula transfer to the skin as measured with tape stripping.

Trial Locations

Locations (1)

Essity Study Site; 🇸🇪 Gothenburg, Sweden