Birch Pollen AllergyNCT02074930
Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure
A study testing Microporation by P.L.E.A.S.E. Professional / Prick needle in people with Birch Pollen Allergy, run by University of Zurich at 1 site in Switzerland.
Trial summary
It is an open-label physiological investigation of the allergic skin reactivity to epicutaneous allergen exposition in 20 allergic patients in two different skin conditions. The focus of the study is on the skin preparation/condition and not on the specific allergen or allergy, but for reasons of homogeneity a single… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Birch Pollen Allergy
- What is being tested?
- Microporation by P.L.E.A.S.E. Professional / Prick needle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2014to Apr 2014
- Phase
- Interventional
- 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
- Written informed consent,
- 18-65 years old (male or female),
- a positive clinical history for inhalant allergy presumably due to birch pollen,
- positive screening prick test (mean wheal diameter bigger or equal than 3mm) to birch pollen allergen solution,
- a mean wheal size of bigger or equal than 7mm2 obtained in the screening prick test with histamine dihydrochloride (10mg/ml)
Who cannot join
- Impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent,
- enrolment into a clinical trial within last 4 weeks,
- pregnancy or nursing,
- positive skin reaction in the screening prick test to NaCl,
- currently suffering from allergy symptoms,
- history of systemic reactions to allergens,
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- severe diseases influencing the results of the present study by discretion of the investigator,
- immunotherapy with the allergen preparation during the past two years,
- skin lesions and excessive hair-growth in the skin test areas,
- treatment with prohibited concomitant medications with the exception of medications with local effects which will not influence the results of the skin prick tests,
- known or suspected non-compliance, drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Division of Dermatology
Zurich, Canton of Zurich, 8091
About this study
It is an open-label physiological investigation of the allergic skin reactivity to epicutaneous allergen exposition in 20 allergic patients in two different skin conditions. The focus of the study is on the skin preparation/condition and not on the specific allergen or allergy, but for reasons of homogeneity a single allergic disease, birch pollen allergy was chosen as the basis for the testing. In order to evaluate the effects of the two different skin preparation techniques an intraindividual comparison of the skin reactivity in terms of the immediate phase I reaction to serial dilutions of birch pollen extracts was chosen. The serial dilution approach allows a dose dependent effect evaluation and comparison of the sensitivity. The differences will be explained mainly by the two different skin preparations allowing a quantitative comparison of these techniques.
Read the detailed description
The Objective is the determination of the allergic skin reactivity to epicutaneoulsy applied birch pollen allergen extract after skin preparation (microporation by P.L.E.A.S.E. Professional) and standard skin prick test. By using the standard prick test the stratum corneum is overcome by a single puncture (1 mm).
Micropores induced by P.L.E.A.S.E. Professional penetrate the stratum corneum less deep but with a higher density (five pores). It is therefore suggested that a skin preparation with micropores by P.L.E.A.S.E. Professional previously to the allergen contact may lead to a higher sensitivity. Less allergen might still elicit a skin reaction which won?t be seen by a conventional prick skin test. Whereas skin prick test may lead to true-negative (patient shows no allergic reaction on prick skin test but is an allergy sufferer in clinic), IgE-determination may lead to false-positives (patient is determined as allergy sufferer but has no clinical symptoms). So the sensitivity with micropores skin preparation by P.L.E.A.S.E. Professional could be a good compromise. The preparation of the skin with P.L.E.A.S.E. Professional leads to a better understanding of the influence of different types of skin injury patterns on the allergic skin reactivity. Namely, how important is the role of the exposed area, the depth of injury and the keratinocyte activation.
This will be checked in a late phase reaction evaluation.
- Conditions
- Birch Pollen Allergy
- Being tested
- Microporation by P.L.E.A.S.E. Professional / Prick needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microporation by P.L.E.A.S.E. Professional / Prick needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Not described Receives: Device: Microporation by P.L.E.A.S.E. Professional / Prick needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wheal Size (mm^2)
The minimal protein concentration eliciting a wheal size of >0mm^2 will be compared between the two different skin preparation techniques with a Wilcoxon signed ranks test.
Measured: The primary outcome will be assesed after 15min after allergen exposure
Secondary outcomes (1)
Wheal Size
The wheal sizes at 10 HEP, 1 HEP, 0.1 HEP and 0.01 HEP/ml will be compared between the two skin preparation techniques (either with a paired-samples t-test if normally distributed or with a Wilcoxon signed ranks test).
Measured: Wheal size will be assessed after 15 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birch Pollen AllergyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Kündig, MD, Principal investigator, University Hospital Zurich, Division of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074930
- Sponsor's protocol ID
- LPrep
- Status last verified
- Apr 2014
- First submitted
- 17 Feb 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure
- ClinicalTrials.gov ID
- NCT02074930
- Acronym / sponsor ID
- LPrep
- Conditions
- Birch Pollen Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- First posted
- 28 Feb 2014 (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.
It is an open-label physiological investigation of the allergic skin reactivity to epicutaneous allergen exposition in 20 allergic patients in two different skin conditions. The focus of the study is on the skin preparation/condition and not on the specific allergen or allergy, but for reasons of homogeneity a single allergic disease, birch pollen allergy was chosen as the basis for the testing. In order to evaluate the effects of the two different skin preparation techniques an intraindividual comparison of the skin reactivity in terms of the immediate phase I reaction to serial dilutions of birch pollen extracts was chosen. The serial dilution approach allows a dose dependent effect evaluation and comparison of the sensitivity. The differences will be explained mainly by the two different skin preparations allowing a quantitative comparison of these techniques.
Detailed description
The Objective is the determination of the allergic skin reactivity to epicutaneoulsy applied birch pollen allergen extract after skin preparation (microporation by P.L.E.A.S.E. Professional) and standard skin prick test. By using the standard prick test the stratum corneum is overcome by a single puncture (1 mm).
Micropores induced by P.L.E.A.S.E. Professional penetrate the stratum corneum less deep but with a higher density (five pores). It is therefore suggested that a skin preparation with micropores by P.L.E.A.S.E. Professional previously to the allergen contact may lead to a higher sensitivity. Less allergen might still elicit a skin reaction which won?t be seen by a conventional prick skin test. Whereas skin prick test may lead to true-negative (patient shows no allergic reaction on prick skin test but is an allergy sufferer in clinic), IgE-determination may lead to false-positives (patient is determined as allergy sufferer but has no clinical symptoms). So the sensitivity with micropores skin preparation by P.L.E.A.S.E. Professional could be a good compromise. The preparation of the skin with P.L.E.A.S.E. Professional leads to a better understanding of the influence of different types of skin injury patterns on the allergic skin reactivity. Namely, how important is the role of the exposed area, the depth of injury and the keratinocyte activation.
This will be checked in a late phase reaction evaluation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Device: Microporation by P.L.E.A.S.E. Professional / Prick needle |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written informed consent,
- 18-65 years old (male or female),
- a positive clinical history for inhalant allergy presumably due to birch pollen,
- positive screening prick test (mean wheal diameter bigger or equal than 3mm) to birch pollen allergen solution,
- a mean wheal size of bigger or equal than 7mm2 obtained in the screening prick test with histamine dihydrochloride (10mg/ml)
Key exclusion criteria (11 listed)
- Impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent,
- enrolment into a clinical trial within last 4 weeks,
- pregnancy or nursing,
- positive skin reaction in the screening prick test to NaCl,
- currently suffering from allergy symptoms,
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 |
|---|---|---|
| Microporation by P.L.E.A.S.E. Professional / Prick needle | Device | Single Arm |
Primary outcome
Wheal Size (mm^2)
Time frame: The primary outcome will be assesed after 15min after allergen exposure
The minimal protein concentration eliciting a wheal size of >0mm^2 will be compared between the two different skin preparation techniques with a Wilcoxon signed ranks test.
1 secondary outcome
Wheal Size
Time frame: Wheal size will be assessed after 15 Minutes
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 15 Apr 2014.
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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.
Thomas Kündig, MD principal investigator
University Hospital Zurich, Division of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microporation by P.L.E.A.S.E. Professional / Prick needle in people with Birch Pollen Allergy, run by University of Zurich at 1 site in Switzerland.
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 5 inclusion and 11 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 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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.
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?
Wheal Size (mm^2) (time frame: The primary outcome will be assesed after 15min after allergen exposure). 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 15 Apr 2014.