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

Sponsor

Janssen Research & Development, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT02343783

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

6.6

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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].

Condition or Disease	Intervention/Treatment	Phase
Dermatitis, Atopic Asthma Healthy	Other: Allergic Skin Reaction (ASR) Testing and Skin Blister Induction	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy + Atopic Dermatitis + Allergic Asthmatic Participants Healthy participants will be enrolled in order to allow for training on the overall skin blister induction and fluid aspiration process. Participants with atopic dermatitis (AD) or allergic asthma (AA) will be observed for the use of induced skin blisters after allergic skin reaction (ASR).	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.

Arm

Intervention/Treatment

Experimental: Healthy + Atopic Dermatitis + Allergic Asthmatic Participants

Healthy participants will be enrolled in order to allow for training on the overall skin blister induction and fluid aspiration process. Participants with atopic dermatitis (AD) or allergic asthma (AA) will be observed for the use of induced skin blisters after allergic skin reaction (ASR).

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.

Outcome Measures

Primary Outcome Measures

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 [Hour 4 after the end of the blister induction]
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and messenger RNA (mRNA) analysis.
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens [Hour 24 after the end of the blister induction]
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens [Hour 4 after the end of the blister induction]
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.
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens [Hour 24 after the end of the blister induction]
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.

Secondary Outcome Measures

Success Percentage of Repeated Skin Blister Induction and Blister Fluid Aspiration [Day 1 and 8]
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.
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens [4 and 24 Hours after the end of the blister induction]
Cells in the aspirated skin blister fluid will be separated and processed for cell population analysis by flow cytometry and mRNA analysis.
Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens [4 and 24 Hours after the end of the blister induction]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Participant must have signed an informed consent document prior to any study related procedures indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Participant must be willing/able to adhere to the study visit schedule and other requirements, prohibitions and restrictions specified in this protocol

For participants with Asthma:

Participant must have a physician documented diagnosis of asthma for at least 12 months before Screening
Participant must have an Asthma Control Questionnaire 6 (ACQ6) less than (<) 1.5 at Screening

For participants with Atopic Dermatitis:

Participant must have a physician documented diagnosis of atopic dermatitis for at least 12 months before Screening based on UK refinement of the Hanifin and Rajka's diagnostic criteria
Participant must have atopic dermatitis with and Investigators Global Assessment (IGA) score of 2 to 4 at Screening

Exclusion Criteria:

Participant has taken any prohibited or restricted medications as noted below under Prestudy and Concomitant Therapy
Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 6 weeks or 5 half-lives (whichever is longer) before the Screening visit

For participants with Asthma:

Participant has a history of life-threatening asthma, defined as a history of respiratory arrest or requiring intubation for asthma
Participant had been admitted to a hospital for asthma in the 1 year before Screening

For participants with Atopic Dermatitis:

Participant has evidence of any other skin condition that would interfere with assessment of Atopic Dermatitis (AD)
Participant has active AD related infection or has had an active AD infection within 2 weeks of Screening (participants with evidence of colonization on skin swab testing but with no infection are allowed)