Exploring the Influence of Elevated CO2 on Allergic Skin

NCT06244524 | Unknown

• 1 other identifier: EICO2AS
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Affects of Elevated Indoor CO2

Outcome Measures

Primary Outcomes (2)

• Skin barrier evaluation

  We will measure skin barrier integrity by electrical impedance spectroscopy

  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

  After the electrical impedance measurment at 8 hours

Study Arms (2)

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.

Other: High indoor CO2 exposure

Interventions

High indoor CO2 exposure OTHER

The participants will stay and sleep for eight hours in a closed bedroom.

Non-ventilated bedroom

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

Study Officials

• Yasutaka Mitamura, MD PhD

  Swiss Institute of Allergy and Asthma Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasutaka Mitamura, MD PhD

CONTACT

+41 (0) 81 410 08 48; 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: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 6, 2024
• Study Start: March 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 6, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share