nctId: NCT06363786 id: GOOSEBERRY briefTitle: Reducing Skin Surface pH During Skin Occlusion: Changes to Skin Microbiome and Skin Parameters overallStatus: NOT_YET_RECRUITING date: 2024-04-15 date: 2024-05-30 date: 2024-09-30 date: 2024-04-12 date: 2024-04-12 name: Essity Hygiene and Health AB class: INDUSTRY briefSummary: 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. conditions: Incontinence-associated Dermatitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP interventionModelDescription: 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 parameteres and skin mictrobiome is measured on day 3. primaryPurpose: BASIC_SCIENCE masking: NONE count: 20 type: ESTIMATED name: Test patches measure: Changes in skin microbiome as measured by molecular sequencing measure: Changes in skin microbiome diversity as measured by qPCR measure: Skin surface pH measure: Change in Trans Epidermal Water loss measure: Change in skin hydration measure: Change in Skin water profile measure: Presence of low pH formula on the skin sex: ALL minimumAge: 18 Years maximumAge: 80 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Essity Study Site city: Gothenburg zip: SE40503 country: Sweden name: Fredrik Agholme, PhD role: CONTACT phone: +46730323634 email: fredrik.agholme@essity.com name: Ulrika Husmark, PhD role: PRINCIPAL_INVESTIGATOR lat: 57.70716 lon: 11.96679 hasResults: False