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

NCT02343783 | Completed Early Phase 1

• 2 other identifiers: CR106398NOCOMPOUNDNAP0005
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 7

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

Conditions

Dermatitis, Atopic; Asthma; Healthy

Keywords

Atopic Dermatitis; Asthma; Healthy; Skin Blisters; Adult Participants

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Success Percentage of Repeated Skin Blister Induction and Blister Fluid Aspiration

  Day 1 and 8

• 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

• 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

Study Arms (1)

Healthy + Atopic Dermatitis + Allergic Asthmatic Participants

EXPERIMENTAL

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

Interventions

Allergic Skin Reaction (ASR) Testing and Skin Blister Induction OTHER

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.

Healthy + Atopic Dermatitis + Allergic Asthmatic Participants

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (7)

Unknown Facility

Antwerp, Belgium

Location

Unknown Facility

Merksem, Belgium

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Hamburg, Germany

Location

Unknown Facility

Hanover, Germany

Location

Unknown Facility

Kiel, Germany

Location

Unknown Facility

Mönchengladbach, Germany

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Asthma; Blister

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Skin Diseases, Vesiculobullous; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 22, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

BE (2); DE (5)