- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02098551
Skin Testing With Recombinant Bet v 1 and Hypoallergenic Recombinant Bet v 1 Fragments
Skin Testing With Recombinant Bet v 1 and Hypoallergenic Recombinant Bet v 1 Fragments to Dissect the Contribution of IgE to Chronic Allergic Skin Inflammation
Study Overview
Detailed Description
In this study non-IgE-reactive recombinant Bet v 1 (rBet v 1) fragments (F1: aa 1-74; F2: aa 75-160) and the fully IgE-reactive recombinant Bet v 1 (aa 1-160)will be used for skin prick testing and atopy patch testing in birch pollen allergic patients with birch pollen induced exacerbation of atopic dermatitis. For control purposes birch pollen allergic patients without birch pollen-induced atopic eczema, persons with allergies other than to birch and non-allergic people will be tested.
The individuals will be subjected to in vivo skin prick and atopy patch testing with rBet v 1, rBet v 1 fragment 1, rBet v 1 fragment 2 and an equimolar mix of the rBet v 1 fragments. In parallel, the IgE reactivity, and in vitro T cell proliferation, and cytokine production will be studied. Those analyses should help to determine the relevance of IgE mediated mechanisms to chronic skin inflammation and T cell proliferation in AD patients.
A staining for the surface markers chemokine receptor (CCR4)+ and cutaneous lymphocyte antigen (CLA)+ which reportedly are enriched in inflamed skin will further allow to investigate whether patients with high numbers of T lymphocytes expressing CCR4 and CLA tend to exhibit stronger skin inflammation. Moreover, allergen-specific antibody and T cell responses will be analyzed 6-8 weeks after the epicutaneous allergen application.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Vienna, Austria, 1090
- Medical University of Vienna
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Different types of individuals will be recruited and divided in four groups. A total of 30 allergic and non-allergic persons will be included in this study:
patients with Birch pollen-related atopic dermatitis (AD), Birch pollen allergic patients without AD (group 2), allergic individuals without birch pollen allergy and non-allergic individuals.
Description
Inclusion Criteria:
- Age between 18 and 75 years
- They will be available to complete the study
Exclusion Criteria:
- Severe general maladies
- Severe skin inflammation in the test area
- Risk of non-controllable general reaction
- Pregnancy and breast-feeding
- Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies
- Contra-indication for adrenaline
- Patients under long-term treatment with systemic corticosteroids immunosuppressive drugs, tranquilizers or psychoactive drugs
- Positive IgE reaction on hypoallergenic Bet v 1 derivatives
- The subject is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug.
- The subject is at risk of non-compliance with the study procedures/restrictions
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Four (4)
Group 1: Birch pollen-related atopic dermatitis (AD) (n=15) Group 2: Birch pollen allergic patients without AD (n=5) Group 3: Allergic individuals without birch pollen allergy (n=5) Group 4: Non-allergic individuals (n=5) Patients will be tested by SPT and APT: SPT: Histamine, buffer, commercial birch pollen extract, rBet v 1, rBet v 1 fragment 1, rBet v 1 fragment 2, and equimolar rBet v 1 fragment mix (20 and 40 μg/ml) in duplets. APT: birch pollen extract, rBet v 1, rBet v 1 fragment 1, rBet v 1 fragment 2, equimolar mix of rBet v 1 fragments (160 μg/application); negative control with vaseline |
All patients will be tested by skin prick testing (SPT: Histamine, buffer, commercial birch pollen extract, rBet v 1 (20 and 40 μg/ml), rBet v 1 fragment 1 (20 and 40 μg/ml), rBet v 1 fragment 2 (20 and 40 μg/ml), equimolar rBet v 1 fragment mix (20 and 40 μg/ml) in duplets. Atopy patch testing (APT: birch pollen extract, rBet v 1:160 μg/application, rBet v 1 fragment 1: 160 μg/application, rBet v 1 fragment 2: 160 μg/ml, equimolar mix of rBet v 1 fragments: 160 μg/application; negative control with vaseline alone. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants with Positive Atopy Patch Testing Reactions of Each Grade on the European Task Force on Atopic Dermatitis Scale
Time Frame: 6 months
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Birch pollen extract (BPE), as well as rBet v 1 (160mg), rBet v 1 fragment 1 (160mg), rBet v 1 fragment 2 (160mg), and an equimolar rBet v 1 fragment mix (80mg of each rBet v 1 fragment), were applied for 48h in patch test chambers onto nonlesional skin on the backs of the subjects.
After 48h, patches were removed, and reactions were analyzed and photodocumented.
Grading of positive APT reactions (i.e., reactions of more than 4 mm in diameter) was done according the European Task Force on Atopic Dermatitis by a blinded investigator: -, negative result; ?, only erythema, questionable; +, erythema, infiltration; ++, erythema, few papules (<3); +++, erythema, papules from 4 to less than many; ++++, erythema, many or spreading papules; or +++++, erythema, vesicles.
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Rudolf Valenta, MD, Medical University of Vienna
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 147/2009
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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