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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06363786
Other study ID # GOOSEBERRY
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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