Clinical trial NCT06363786: Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence-associated Dermatitis
Lead sponsor: Essity Hygiene and Health AB
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Healthy volunteers get patches carrying a low pH or control formula applied to the forearms. The patches are carried over two days and the skin parameters and skin microbiome is measured on day 3.
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Changes in skin microbiome as measured by molecular sequencing
timeFrame: 2 days
measure: Changes in skin microbiome diversity as measured by qPCR
timeFrame: 2 days
measure: Skin surface pH
timeFrame: 2 days
Secondary outcomes:
measure: Change in Trans Epidermal Water loss
timeFrame: 2 days
measure: Change in skin hydration
timeFrame: 2 days
measure: Change in Skin water profile
timeFrame: 2 days
measure: Presence of low pH formula on the skin
timeFrame: 2 days
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Essity Study Site
Study officials:
affiliation: Essity Hygiene and Health AB
name: Ulrika Husmark, PhD
role: PRINCIPAL_INVESTIGATOR
References: