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

Incontinence-associated Dermatitis Clinical Trial

Official title:

Mitigating the Impact of Absorbent Products on Skin Occlusion: Changes to Skin Microbiome and Skin Parameters Due to Reduction of Skin Surface pH in Healthy Participants

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363786
• Other study ID #: GOOSEBERRY
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: April 2024
• Source: Essity Hygiene and Health AB
• Contact: Fredrik Agholme, PhD
• Phone: 0730323634
• Email: fredrik.agholme[@]essity.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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 pathces. 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 approproate statistical tests on 5% level for varaibles. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: September 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dermatitis
• Incontinence-associated Dermatitis

Intervention

Other:
• Test patches
Patches (incontince product cut outs) with a low pH formula or control patches without formula.

Locations

Country	Name	City	State
Sweden	Essity Study Site	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Essity Hygiene and Health AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in skin microbiome as measured by molecular sequencing	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.	2 days
Primary	Changes in skin microbiome diversity as measured by qPCR	qPCR is employed to analyse and quantify specific microbial species or groups. Skin under the test and control patches are compared.	2 days
Primary	Skin surface pH	The change in skin surface pH under the test and control patches are compared.	2 days
Secondary	Change in Trans Epidermal Water loss	As measured by Dermalab instrument. Transepidermal water loss (TEWL) as measured under the test and control patches.	2 days
Secondary	Change in skin hydration	Skin hydration (SH) as measured with moisturemeter instrument under the test and control patches.	2 days
Secondary	Change in Skin water profile	As measured Confocal raman microspectometry. The water content of skin at different depths is measured and compared for the skin under test and control patches.	2 days
Secondary	Presence of low pH formula on the skin	The extent on formula transfer to the skin as measured with tape stripping.	2 days