Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants

NCT06269315 | Not Yet Recruiting

• 1 other identifier: SBDDCP
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Skin barrier evaluation

  We will measure skin barrier integrity by electrical impedance spectroscopy

  before the application (0), right after the removal (5 min), 1, 3, and 24 hours after the treatment

Study Arms (1)

Exposure arm

EXPERIMENTAL

Prepared test products, such as household cleaner, hand disinfectant, their ingredients, and control on patch testing tapes will be posted on the selected areas of forearm skin.

Other: Cleaning product exposure

Interventions

Cleaning product exposure OTHER

Exposure of a small amount of a different household cleaner, hand disinfectant, their ingredients, and control with proper dilution on forearm of donors

Exposure arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The study population will consist of healthy adult volunteers; 1. age between18 and 65 years, 2. Generally healthy and able to provide written informed consent. The choice of healthy adult volunteers without pre-existing skin conditions on site or allergies against tested products is justified.

You may not qualify if:

• Severe dermatitis, eczema, psoriasis, or other chronic skin conditions.
• History of hypersensitivity or allergies to tested product ingredients.
• Current or recent systemic therapy for a skin condition in the past six months.
• Pregnant or breastfeeding individuals.
• Use of investigational drugs or participation in another trial in the last 30 days.
• History of skin cancer or malignancies in the study area.
• Significant sunburn, open wounds, or active skin infections in the study area.
• Any medical condition that, per the investigator, might compromise safety or confound results.
• Inability to follow study instructions or attend required clinic visits.
• Gender Balance: To ensure gender balance, efforts will be made to recruit an equal number of male and female participants.

Sponsors & Collaborators

• Swiss Institute of Allergy and Asthma Research: lead
• University Hospital, Zürich: collaborator

Study Sites (1)

Swiss Institute of Allergy and Asthma Research

Davos, Kanton Graubünden, 7265, Switzerland

Location

Central Study Contacts

Yasutaka Mitamura, MD PhD

CONTACT

41 81 410 0848; yasutaka.mitamura@siaf.uzh.ch

Cezmi A Akdis, MD professor

CONTACT

+41 (0) 81 410 08 48; cezmi.akdis@siaf.uzh.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 21, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 1, 2025
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)