Control Condition (PBS)SBDDCPNCT06269315
Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants
A study testing Cleaning product exposure in people with Control Condition (PBS) and Household Detergent Exposure, run by Swiss Institute of Allergy and Asthma Research at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Control Condition (PBS), Household Detergent Exposure, Hand Disinfectant Exposure
- What is being tested?
- Cleaning product exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2024to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Institute of Allergy and Asthma Research
Davos, Kanton Graubünden, 7265
Yasutaka Mitamura, MD PhD, +41 (0) 81 410 08 48, yasutaka.mitamura@siaf.uzh.ch
Cezmi A Akdis, MD professor, +41 (0) 81 410 08 48, cezmi.akdis@siaf.uzh.ch
About this study
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:
Read more
- 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.
Read the detailed description
- Core Message: Understanding the effects of detergent and disinfectant exposure on skin barrier integrity is crucial for public health, particularly given their widespread use.
- Supporting Information: Studies suggest an association between cleaning agents and skin barrier disruption. Skin barrier function can be assessed using various methods, including electrical impedance spectroscopy (EIS).
- Key Points: Scientific Question: Investigate how household detergent, hand disinfectant, and their ingredients exposure affect skin barrier function. Proposed Intervention: Conduct controlled human skin exposure experiments with properly diluted household detergents, hand disinfectants, and their ingredients. Scientific Basis: Previous research indicates potential risks associated with cleaning agent exposure and validates EIS as a suitable assessment tool.
- Objectives: Hypothesis: Household detergent and hand disinfectant exposure damage skin barrier integrity. Primary Objective: Demonstrate the effect of cleaning agent exposure on skin barrier function.
- Study Population and Procedures: Inclusion criteria: Healthy adult volunteers aged 18-65. Exclusion criteria: Individuals with chronic skin conditions, allergies, or recent systemic therapy. Recruitment through ongoing processes and physician referrals. Informed consent emphasizing voluntary participation and the right to withdraw.
- Statistics and Methodology: Sample size: 50 participants. Intervention: Participants will be exposed to controlled amounts of household detergents, hand disinfectants, and their ingredients. Assessment methods: EIS for skin barrier integrity evaluation. Statistical methods: Analysis using appropriate tests to detect significant differences.
- Regulatory Aspects and Safety: Compliance with ethical guidelines and local regulations. Immediate reporting of adverse events and regular safety monitoring.
- Quality Control and Data Protection: Measures include personnel training, SOPs, and data security protocols. Data is handled with discretion and stored securely.
- Monitoring and Registration: Regular monitoring by research institutions (SIAF and UZH). This study will be registered with the Swiss National Clinical Trial Portal (SNCTP via BASEC) and ClinicalTrials.gov.
- Funding / Publication / Declaration of Interest:
Funding from Swiss National Foundation (Prof. Cezmi Akdis) and SciBase. Commitment to transparency, open science, and conflict-free reporting. Multicentre collaboration between SIAF and Department of Dermatology, UZH.
- Conditions
- Control Condition (PBS), Household Detergent Exposure, Hand Disinfectant Exposure, Surfactant Exposure, Other Ingredients Exposure
- Being tested
- Cleaning product exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleaning product exposureOther
Exposure of a small amount of a different household cleaner, hand disinfectant, their ingredients, and control with proper dilution on forearm of donors
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cleaning product exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin barrier evaluation
We will measure skin barrier integrity by electrical impedance spectroscopy
Measured: before the application (0), right after the removal (5 min), 1, 3, and 24 hours after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Control Condition (PBS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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 (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Institute of Allergy and Asthma Research
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269315
- Sponsor's protocol ID
- SBDDCP
- Acronym
- SBDDCP
- Status last verified
- Feb 2024
- First submitted
- 12 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skin Barrier Disruption Due to Daily Use of Cleaning Products and Hand Disinfectants
- ClinicalTrials.gov ID
- NCT06269315
- Acronym / sponsor ID
- SBDDCP / SBDDCP
- Conditions
- Control Condition (PBS), Household Detergent Exposure, Hand Disinfectant Exposure, Surfactant Exposure, Other Ingredients Exposure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Swiss Institute of Allergy and Asthma ResearchUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Core Message: Understanding the effects of detergent and disinfectant exposure on skin barrier integrity is crucial for public health, particularly given their widespread use.
- Supporting Information: Studies suggest an association between cleaning agents and skin barrier disruption. Skin barrier function can be assessed using various methods, including electrical impedance spectroscopy (EIS).
- Key Points: Scientific Question: Investigate how household detergent, hand disinfectant, and their ingredients exposure affect skin barrier function. Proposed Intervention: Conduct controlled human skin exposure experiments with properly diluted household detergents, hand disinfectants, and their ingredients. Scientific Basis: Previous research indicates potential risks associated with cleaning agent exposure and validates EIS as a suitable assessment tool.
- Objectives: Hypothesis: Household detergent and hand disinfectant exposure damage skin barrier integrity. Primary Objective: Demonstrate the effect of cleaning agent exposure on skin barrier function.
- Study Population and Procedures: Inclusion criteria: Healthy adult volunteers aged 18-65. Exclusion criteria: Individuals with chronic skin conditions, allergies, or recent systemic therapy. Recruitment through ongoing processes and physician referrals. Informed consent emphasizing voluntary participation and the right to withdraw.
- Statistics and Methodology: Sample size: 50 participants. Intervention: Participants will be exposed to controlled amounts of household detergents, hand disinfectants, and their ingredients. Assessment methods: EIS for skin barrier integrity evaluation. Statistical methods: Analysis using appropriate tests to detect significant differences.
- Regulatory Aspects and Safety: Compliance with ethical guidelines and local regulations. Immediate reporting of adverse events and regular safety monitoring.
- Quality Control and Data Protection: Measures include personnel training, SOPs, and data security protocols. Data is handled with discretion and stored securely.
- Monitoring and Registration: Regular monitoring by research institutions (SIAF and UZH). This study will be registered with the Swiss National Clinical Trial Portal (SNCTP via BASEC) and ClinicalTrials.gov.
- Funding / Publication / Declaration of Interest:
Funding from Swiss National Foundation (Prof. Cezmi Akdis) and SciBase. Commitment to transparency, open science, and conflict-free reporting. Multicentre collaboration between SIAF and Department of Dermatology, UZH.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exposure arm | Experimental | Other: Cleaning product exposurePrepared 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cleaning product exposureExposure of a small amount of a different household cleaner, hand disinfectant, their ingredients, and control with proper dilution on forearm of donors | Other | Exposure arm |
Primary outcome
Skin barrier evaluation
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleaning product exposure in people with Control Condition (PBS) and Household Detergent Exposure, run by Swiss Institute of Allergy and Asthma Research at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasutaka Mitamura, MD PhD (41 81 410 0848, yasutaka.mitamura@siaf.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin barrier evaluation (time frame: before the application (0), right after the removal (5 min), 1, 3, and 24 hours after the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.