The purpose of this study is to characterize the cell (the basic building block of all living things) populations and inflammatory (pain and swelling) mediator responses in suction skin blister fluid after allergic skin reaction (ASR) \[rash\] induction with D. Pteronyssinus \[house dust mite (HDM)\], Alternaria alternata, or Aspergillus fumigatus allergens in participants with atopic dermatitis (AD) \[Skin rash, Eczema\] or allergic asthma (AA) \[breathing disorder in which there is a wheezing and difficulty breathing\].
This is an interventional (a treatment given during the course of a research study) and multicenter (when more than one hospital or medical school team work on a medical research study) study. The study will consist of 3 Phases: Screening Phase (Up to 4 weeks), Data Collection Phase (9 days) and, Follow-up Phase (7 days). The maximum study duration for each participant will not exceed 43 days. Primarily, the cell populations and inflammatory mediator responses in suction skin blister fluid after allergic skin reaction (ASR) will be assessed. Participants' safety will be monitored throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
Participants will not receive any intervention in this study. Healthy participants will be enrolled in order to allow for training on the overall skin blister induction and fluid aspiration process. The cell populations and inflammatory mediator responses in suction skin blister fluid after allergic skin reaction (ASR) in participants with atopic dermatitis (AD) or allergic asthma (AA) will be observed.
Unnamed facility
Antwerp, Belgium
Unnamed facility
Merksem, Belgium
Unnamed facility
Berlin, Germany
Unnamed facility
Hamburg, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Kiel, Germany
Unnamed facility
Mönchengladbach, Germany
Cell Concentration in Suction Skin Blister Fluid After Allergic Skin Reaction (ASR) Induction with D. Pteronyssinus (House Dust Mite [HDM]), Alternaria alternata, or Aspergillus fumigatus Allergens
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and messenger RNA (mRNA) analysis.
Time frame: Hour 4 after the end of the blister induction
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Time frame: Hour 24 after the end of the blister induction
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.
Time frame: Hour 4 after the end of the blister induction
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.
Time frame: Hour 24 after the end of the blister induction
Success Percentage of Repeated Skin Blister Induction and Blister Fluid Aspiration
Success percentage for blister induction will be defined as number of blisters formed with recovery of at least 200 microliter (μL) of blister fluid, divided by the total blisters induced.
Time frame: Day 1 and 8
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Time frame: 4 and 24 Hours after the end of the blister induction
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
The remaining fluid from aspirated skin blister fluid after separated and processed for cell population analysis will be assessed for inflammatory mediator responses. Inflammatory cytokines and other soluble mediators in blister fluid will be measured by immunoassay.
Time frame: 4 and 24 Hours after the end of the blister induction
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