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.

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].

Study Overview

• Status: Completed
• Conditions: Healthy; Asthma; Dermatitis, Atopic
• Intervention / Treatment: Other: Allergic Skin Reaction (ASR) Testing and Skin Blister Induction

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium
  • Merksem, Belgium
• Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Hannover, Germany
  • Kiel, Germany
  • Mönchengladbach, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Hour 24 after the end of the blister induction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	4 and 24 Hours after the end of the blister induction

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: January 16, 2015
• First Submitted That Met QC Criteria: January 16, 2015
• First Posted (ESTIMATE): January 22, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 2, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Asthma; Healthy; Atopic Dermatitis; Skin Blisters; Adult Participants
• Additional Relevant MeSH Terms: Skin Diseases; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Genetic Diseases, Inborn; Pathological Conditions, Anatomical; Skin Diseases, Genetic; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Skin Diseases, Vesiculobullous; Skin Diseases, Eczematous; Asthma; Dermatitis; Eczema; Blister; Dermatitis, Atopic
• Other Study ID Numbers: CR106398; NOCOMPOUNDNAP0005 (OTHER: Janssen Research & Development, LLC)