Dermatitis, AtopicEarly Phase 1NCT02343783
A Study to Evaluate Use of Induced Skin Blisters in Adult Participants With Atopic Dermatitis, Allergic Asthma and Atopic Healthy Participants
A Early Phase 1 study testing Allergic Skin Reaction (ASR) Testing and Skin Blister Induction in people with Dermatitis, Atopic and Asthma, run by Janssen Research & Development, LLC at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatitis, Atopic, Asthma, Healthy
- What is being tested?
- Allergic Skin Reaction (ASR) Testing and Skin Blister Induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Jan 2015to Sep 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
Germany5 sites
Study site
Berlin
Study site
Hamburg
Study site
Hanover
Study site
Kiel
Study site
Mönchengladbach
About this study
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.
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].
Read the 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
- Being tested
- Allergic Skin Reaction (ASR) Testing and Skin Blister Induction
- Keywords
- Atopic Dermatitis, Asthma, Healthy, Skin Blisters, Adult Participants
- Medical subject headings
- Dermatitis, Atopic, Asthma, Blister
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergic Skin Reaction (ASR) Testing and Skin Blister InductionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Allergic Skin Reaction (ASR) Testing and Skin Blister Induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Hour 24 after the end of the blister induction
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 4 and 24 Hours after the end of the blister induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatitis, AtopicStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343783
- Sponsor's protocol ID
- CR106398
- Other IDs
- NOCOMPOUNDNAP0005
- Status last verified
- Oct 2015
- First submitted
- 16 Jan 2015
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02343783
- Acronym / sponsor ID
- CR106398
- Conditions
- Dermatitis, Atopic, Asthma, Healthy
- Keywords
- Atopic Dermatitis, Asthma, Healthy, Skin Blisters, Adult Participants
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy + Atopic Dermatitis + Allergic Asthmatic Participants | Experimental | Other: Allergic Skin Reaction (ASR) Testing and Skin Blister InductionHealthy 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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- 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
- 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
Key exclusion criteria (8 listed)
- 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
- 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
- Participant has evidence of any other skin condition that would interfere with assessment of Atopic Dermatitis (AD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergic Skin Reaction (ASR) Testing and Skin Blister InductionParticipants 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. | Other | Healthy + Atopic Dermatitis + Allergic Asthmatic Participants |
Primary outcome
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Success Percentage of Repeated Skin Blister Induction and Blister Fluid Aspiration
Time frame: Day 1 and 8
Cell Concentration in Suction Skin Blister Fluid After ASR Induction with Non-protease Allergens
Time frame: 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
Time frame: 4 and 24 Hours after the end of the blister induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Allergic Skin Reaction (ASR) Testing and Skin Blister Induction in people with Dermatitis, Atopic and Asthma, run by Janssen Research & Development, LLC at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Hour 4 after the end of the blister induction). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.