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

NCT ID: NCT06363786

Last Updated: 2025-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2024-08-30

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.

Conditions

Incontinence-associated Dermatitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Test patches

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

Group Type: EXPERIMENTAL

Test patches

Intervention Type: OTHER

Patches (incontinence product cut outs) with a low pH formula or control patches without formula.

Interventions

Test patches

Patches (incontinence product cut outs) with a low pH formula or control patches without formula.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Essity Hygiene and Health AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ulrika Husmark, PhD

Role: PRINCIPAL_INVESTIGATOR

Essity Hygiene and Health AB

Locations

Essity Study Site

Gothenburg, , Sweden

Countries

Sweden

Other Identifiers

GOOSEBERRY

Identifier Type: -

Identifier Source: org_study_id