Essity Study Site
Gothenburg, SE40503, Sweden
NCT Number: NCT06363786
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Gothenburg, SE40503, Sweden
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patches (incontinence product cut outs) with a low pH formula or control patches without formula.
Time frame: 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.
Time frame: 2 days
qPCR is employed to analyse and quantify specific microbial species or groups. Skin under the test and control patches are compared.
Time frame: 2 days
The change in skin surface pH under the test and control patches are compared.
Time frame: 2 days
As measured by Dermalab instrument. Transepidermal water loss (TEWL) as measured under the test and control patches.
Time frame: 2 days
Skin hydration (SH) as measured with moisture meter instrument under the test and control patches.
Time frame: 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.
Time frame: 2 days
The extent on formula transfer to the skin as measured with tape stripping.
Essity Hygiene and Health AB
Industry
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
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