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

NCT ID: NCT02343783

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

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].

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Allergic Skin Reaction (ASR) Testing and Skin Blister Induction

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Antwerp, , Belgium

Merksem, , Belgium

Berlin, , Germany

Hamburg, , Germany

Hanover, , Germany

Kiel, , Germany

Mönchengladbach, , Germany

Countries

Belgium; Germany

Other Identifiers

NOCOMPOUNDNAP0005

Identifier Type: OTHER

Identifier Source: secondary_id

CR106398

Identifier Type: -

Identifier Source: org_study_id