- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02074930
Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZH
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Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Division of Dermatology
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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,
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single Arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
The primary outcome will be assesed after 15min after allergen exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Wheal Size
Time Frame: Wheal size will be assessed after 15 Minutes
|
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).
|
Wheal size will be assessed after 15 Minutes
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas Kündig, MD, University Hospital Zurich, Division of Dermatology
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LPrep
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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