Affects of Elevated Indoor CO2EICO2ASNCT06244524
Exploring the Influence of Elevated CO2 on Allergic Skin
A study testing High indoor CO2 exposure in people with Affects of Elevated Indoor CO2, run by Swiss Institute of Allergy and Asthma Research.
Trial summary
The goal of this clinical trial is to investigate the impact of elevated indoor CO2 levels on skin barrier function and inflammation in healthy adults. The main questions it aims to answer are: How do increased indoor CO2 levels contribute to type 2 inflammation and barrier dysfunction in human skin? What is the… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Affects of Elevated Indoor CO2
- What is being tested?
- High indoor CO2 exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Mar 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
No sites are listed yet.
About this study
Official title: Exploring the Influence of Elevated Indoor CO2 Levels on Allergic Skin Disorders
The goal of this clinical trial is to investigate the impact of elevated indoor CO2 levels on skin barrier function and inflammation in healthy adults. The main questions it aims to answer are:
How do increased indoor CO2 levels contribute to type 2 inflammation and barrier dysfunction in human skin? What is the demonstrable impact of high CO2 exposure on the human skin barrier and transcriptome? Participants will be exposed to controlled levels of CO2 in either well-ventilated or non-ventilated (closed) bedrooms.
Read more
We will evaluate epithelial barrier function by electrical impedance spectroscopy (EIS), collect skin biopsy samples, and investigate the change induced by high indoor CO2 exposure. Healthy adults meeting the inclusion criteria will be included and those with chronic skin conditions, allergies, or recent systemic therapy will be excluded.
Researchers will compare participants exposed to elevated CO2 levels in closed bedrooms with those in well-ventilated bedrooms to determine if skin barrier integrity and transcriptome variations are observed.
Read the detailed description
- Core Message: Elevated indoor CO2 levels in closed rooms may contribute to skin barrier dysfunction and inflammation. Understanding the impact of increasing CO2 on the skin is essential to public health.
- Supporting Information: Atopic dermatitis (AD) affects a significant population, and indoor CO2 levels are rising in the bedroom. Preliminary studies demonstrate the association between CO2 exposure and skin barrier dysfunction. Skin barrier functions can be assessed by electrical impedance spectroscopy (EIS) in vivo.
- Key Points: Scientific Question: Investigate how increased indoor CO2 levels contribute to type 2 inflammation and barrier dysfunction in human skin. Proposed Intervention: Controlled human skin CO2 exposure experiments in well-ventilated vs. non-ventilated (closed) bedrooms. Scientific Basis: Preliminary studies have shown that elevated CO2 levels in closed spaces and validate EIS as a reliable assessment tool for skin barrier integrity assessment.
- Objectives: Hypothesis: Elevated indoor CO2 affects skin homeostasis and barrier function. Primary Objective: Demonstrate the impact of high CO2 exposure on the human skin barrier and transcriptome.
- Study Population and Procedures: Inclusion criteria: Healthy adults aged 18-65. Exclusion criteria: Individuals with chronic skin conditions, allergies, or recent systemic therapy. Recruitment through ongoing processes and physician referrals. Informed consent emphasizes voluntary participation and the right to withdraw.
- Statistics and Methodology: Sample size: 50 participants to detect meaningful differences. Intervention: Participants will be randomly assigned to well-ventilated or non-ventilated (closed) bedrooms groups. The researcher will evaluate epithelial barrier by electrical impedance spectroscopy at 0h (before the exposure) and 8h (after the exposure). After exposure, the skin biopsy will be collected from the epithelial barrier measurement site. Statistical methods: Mann-Whitney U test and t-test for data analysis.
- Regulatory Aspects and Safety: Compliance with Declaration of Helsinki, ICH-GCP, and local regulations. Immediate reporting of Adverse Events (AEs). Annual safety reports and notification of safety measures.
- Quality Control and Data Protection: Measures include personnel training, SOPs, double data entry, and regular reviews. Data is handled with discretion, identified by unique participant numbers, and stored securely for 10 years.
- Monitoring and Registration: SIAF and UZH will conduct monitoring; participants visit these sites for assessments. 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 Pathway Global Grant (Sanofi) and SciBase. Commitment to transparency, open science, and conflict-free reporting. Multicentre collaboration between SIAF and Swiss Dermatology Clinic.
- Conditions
- Affects of Elevated Indoor CO2
- Being tested
- High indoor CO2 exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High indoor CO2 exposureOther
The participants will stay and sleep for eight hours in a closed bedroom.
| Study group | Role | What they receive |
|---|---|---|
| Well-ventilated bedroom | No intervention | The participants will stay and sleep for eight hours in a well-ventilated bedroom. |
| Non-ventilated bedroom | Experimental | The participants will stay and sleep for eight hours in a closed bedroom. Receives: Other: High indoor CO2 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 (0 hour) and after 8 hours of sleep in ventilated or closed bedroom.
Skin biopsy collection
We will collect skin biopsy from the forearm that we measure electrical impedance
Measured: After the electrical impedance measurment at 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study startMar 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Affects of Elevated Indoor CO2Studies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The recruited healthy donors will be randomly distributed into ventilated or closed bedrooms. We will assess the epithelial barrier function on their forearm by electrical impedance spectroscopy before and after 8 hours of sleep in each bedroom. The level of CO2 in the bedrooms will be monitored. In addition, the skin biopsy samples will be collected from fore arm.
- 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
- Responsible party
- Sponsor
- Investigators
- Yasutaka Mitamura, MD PhD, Principal investigator, Swiss Institute of Allergy and Asthma Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244524
- Sponsor's protocol ID
- EICO2AS
- Acronym
- EICO2AS
- Status last verified
- Jan 2024
- First submitted
- 29 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- 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 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Influence of Elevated Indoor CO2 Levels on Allergic Skin Disorders
- ClinicalTrials.gov ID
- NCT06244524
- Acronym / sponsor ID
- EICO2AS / EICO2AS
- Conditions
- Affects of Elevated Indoor CO2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Swiss Institute of Allergy and Asthma ResearchUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 6 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 investigate the impact of elevated indoor CO2 levels on skin barrier function and inflammation in healthy adults. The main questions it aims to answer are:
How do increased indoor CO2 levels contribute to type 2 inflammation and barrier dysfunction in human skin? What is the demonstrable impact of high CO2 exposure on the human skin barrier and transcriptome? Participants will be exposed to controlled levels of CO2 in either well-ventilated or non-ventilated (closed) bedrooms.
We will evaluate epithelial barrier function by electrical impedance spectroscopy (EIS), collect skin biopsy samples, and investigate the change induced by high indoor CO2 exposure. Healthy adults meeting the inclusion criteria will be included and those with chronic skin conditions, allergies, or recent systemic therapy will be excluded.
Researchers will compare participants exposed to elevated CO2 levels in closed bedrooms with those in well-ventilated bedrooms to determine if skin barrier integrity and transcriptome variations are observed.
Detailed description
- Core Message: Elevated indoor CO2 levels in closed rooms may contribute to skin barrier dysfunction and inflammation. Understanding the impact of increasing CO2 on the skin is essential to public health.
- Supporting Information: Atopic dermatitis (AD) affects a significant population, and indoor CO2 levels are rising in the bedroom. Preliminary studies demonstrate the association between CO2 exposure and skin barrier dysfunction. Skin barrier functions can be assessed by electrical impedance spectroscopy (EIS) in vivo.
- Key Points: Scientific Question: Investigate how increased indoor CO2 levels contribute to type 2 inflammation and barrier dysfunction in human skin. Proposed Intervention: Controlled human skin CO2 exposure experiments in well-ventilated vs. non-ventilated (closed) bedrooms. Scientific Basis: Preliminary studies have shown that elevated CO2 levels in closed spaces and validate EIS as a reliable assessment tool for skin barrier integrity assessment.
- Objectives: Hypothesis: Elevated indoor CO2 affects skin homeostasis and barrier function. Primary Objective: Demonstrate the impact of high CO2 exposure on the human skin barrier and transcriptome.
- Study Population and Procedures: Inclusion criteria: Healthy adults aged 18-65. Exclusion criteria: Individuals with chronic skin conditions, allergies, or recent systemic therapy. Recruitment through ongoing processes and physician referrals. Informed consent emphasizes voluntary participation and the right to withdraw.
- Statistics and Methodology: Sample size: 50 participants to detect meaningful differences. Intervention: Participants will be randomly assigned to well-ventilated or non-ventilated (closed) bedrooms groups. The researcher will evaluate epithelial barrier by electrical impedance spectroscopy at 0h (before the exposure) and 8h (after the exposure). After exposure, the skin biopsy will be collected from the epithelial barrier measurement site. Statistical methods: Mann-Whitney U test and t-test for data analysis.
- Regulatory Aspects and Safety: Compliance with Declaration of Helsinki, ICH-GCP, and local regulations. Immediate reporting of Adverse Events (AEs). Annual safety reports and notification of safety measures.
- Quality Control and Data Protection: Measures include personnel training, SOPs, double data entry, and regular reviews. Data is handled with discretion, identified by unique participant numbers, and stored securely for 10 years.
- Monitoring and Registration: SIAF and UZH will conduct monitoring; participants visit these sites for assessments. 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 Pathway Global Grant (Sanofi) and SciBase. Commitment to transparency, open science, and conflict-free reporting. Multicentre collaboration between SIAF and Swiss Dermatology Clinic.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The recruited healthy donors will be randomly distributed into ventilated or closed bedrooms. We will assess the epithelial barrier function on their forearm by electrical impedance spectroscopy before and after 8 hours of sleep in each bedroom. The level of CO2 in the bedrooms will be monitored. In addition, the skin biopsy samples will be collected from fore arm.
| Arm | Type | Receives |
|---|---|---|
| Well-ventilated bedroom | No intervention | –The participants will stay and sleep for eight hours in a well-ventilated bedroom. |
| Non-ventilated bedroom | Experimental | Other: High indoor CO2 exposureThe participants will stay and sleep for eight hours in a closed bedroom. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 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 |
|---|---|---|
| High indoor CO2 exposureThe participants will stay and sleep for eight hours in a closed bedroom. | Other | Non-ventilated bedroom |
Primary outcome
Skin barrier evaluation
Time frame: before (0 hour) and after 8 hours of sleep in ventilated or closed bedroom.
We will measure skin barrier integrity by electrical impedance spectroscopy
Skin biopsy collection
Time frame: After the electrical impedance measurment at 8 hours
We will collect skin biopsy from the forearm that we measure electrical impedance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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.
Yasutaka Mitamura, MD PhD principal investigator
Swiss Institute of Allergy and Asthma Research
Questions about this trial
What is this clinical trial studying?
A study testing High indoor CO2 exposure in people with Affects of Elevated Indoor CO2, run by Swiss Institute of Allergy and Asthma Research.
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 2 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 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 (0) 81 410 08 48, 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 (0 hour) and after 8 hours of sleep in ventilated or closed bedroom.). The study lists 2 primary outcomes in all. 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 6 Feb 2024.