Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-01 @ 12:04 AM
Study NCT ID:
NCT02098551
Status:
COMPLETED
Last Update Posted:
2015-12-08
First Post:
2011-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Skin Testing With Recombinant Bet v 1 and Hypoallergenic Recombinant Bet v 1 Fragments
Sponsor:
Stefan Woehrl
Organization:
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of this study is to use the major allergen 1 of birch-tree pollen (Bet v 1, Betula verrucosa, synonymous Betula pendula), to investigate the contribution of immunoglobulin E (IgE)- versus non-IgE-mediated mechanisms to chronic skin inflammation in atopic dermatitis patients.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: