Interventional Not yet recruiting
NCT06269315 on ClinicalTrials.gov
Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants
- Sponsor: Swiss Institute of Allergy and Asthma Research
- Collaborators: University Hospital, Zürich
- Enrollment: 50 (Estimated)
- Study start: 2024-04-01 (Estimated)
- Primary completion: 2024-12-31 (Estimated)
- Study completion: 2025-04-01 (Estimated)
- Allocation: N/a
- InterventionModel: Single Group
- InterventionModelDescription: 1. Skin Cleansing and Testing Patch Preparation: Prepare a test set of patch testing tapes, each containing a small amount of a different household cleaner, hand disinfectant, their ingredients, and control with proper dilution. The safety dose of the tested products and agents will be defined beforehand. Before exposure, selected areas of forearm skin will be cleaned and moistened. Electrical impedance will be measured by electrical impedance spectroscopy (EIS) to assess skin barrier integrity. 2. Patch Application: Apply the prepared patches on the skin of the forearm. Patches will be removed after 5 minutes of exposure. During the exposure period, subjects will be instructed not to touch, wash, or wet the exposed area to avoid interfering with the action of the testing reagents. 3. Patch Removal and Post-Exposure Monitoring: The patch will be gently removed from the skin. Exposed areas of skin will be evaluated by EIS at specific times up to 24 hours after the treatment.
- Masking: None
- PrimaryPurpose: Basic Science
Brief Summary
The goal of this clinical trial is to assess the effects of household detergents and hand disinfectants on human skin barrier integrity among healthy adult volunteers.
The main questions it aims to answer are:
* How does exposure to household detergents and hand disinfectants impact skin barrier function?
* Are there differences in skin barrier disruption between various types of cleaning agents and disinfectants?
Participants will:
Undergo patch testing with controlled amounts of household detergents and hand disinfectants on a small area of their skin.
Be monitored for adverse reactions during and after exposure. Have their skin barrier integrity assessed using electrical impedance spectroscopy at multiple time points post-exposure.
If there is a comparison group:
Researchers will compare the effects of different types of cleaning agents, hand disinfectants, and their ingredients on skin barrier integrity to determine variations in their impact.
Conditions
- Control Condition (PBS)
- Household Detergent Exposure
- Hand Disinfectant Exposure
- Surfactant Exposure
- Other Ingredients Exposure
Intervention / Treatment
- Other: Cleaning product exposure
Primary Outcome Measures
-
Skin barrier evaluation
(before the application (0), right after the removal (5 min), 1, 3, and 24 hours after the treatment)
We will measure skin barrier integrity by electrical impedance spectroscopy
Countries
Switzerland
Locations and Investigators
-
Swiss Institute of Allergy and Asthma Research, Davos, Switzerland
- Yasutaka Mitamura, MD PhD
- Cezmi A Akdis, MD professor
- Manru Li
- Marie-Charlotte Brueggen, MD PhD professor