Clinical trial NCT02343783: A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dermatitis, Atopic
Asthma
Healthy
Keywords: Atopic Dermatitis
Asthma
Healthy
Skin Blisters
Adult Participants
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2015-01-22
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: 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
timeFrame: Hour 4 after the end of the blister induction
measure: Cell Concentration in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
timeFrame: Hour 24 after the end of the blister induction
measure: Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
timeFrame: Hour 4 after the end of the blister induction
measure: Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with D. Pteronyssinus (House Dust Mite), Alternaria alternata, or Aspergillus fumigatus Allergens
timeFrame: Hour 24 after the end of the blister induction
Secondary outcomes:
measure: Success Percentage of Repeated Skin Blister Induction and Blister Fluid Aspiration
timeFrame: Day 1 and 8
measure: Cell Concentration in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
timeFrame: 4 and 24 Hours after the end of the blister induction
measure: Levels of Inflammatory Mediators in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
timeFrame: 4 and 24 Hours after the end of the blister induction
Other outcomes:
Locations:
city: Antwerp
country: Belgium
city: Merksem
country: Belgium
city: Berlin
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Kiel
country: Germany
city: Mönchengladbach
country: Germany
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: