NCT02343783

A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants

A Phase 0 Study Exploring the Use of Induced Skin Blisters in Adult Subjects With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Subjects.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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) \[breathing disorder in which there is a wheezing and difficulty breathing\].

Detailed description

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.

Conditions

• Dermatitis, Atopic
• Asthma
• Healthy

Interventions

Type	Name	Description
OTHER	Allergic Skin Reaction (ASR) Testing and Skin Blister Induction	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-01-22
• Last updated: 2015-10-06

Locations

7 sites across 2 countries: Belgium, Germany