Last updated: April 18, 2023
Sponsor: Medical University of Warsaw
Overall Status: Active - Recruiting
Phase
N/A
Condition
Atopic Dermatitis
Allergy (Peanut)
Hives (Urticaria)
Treatment
N/AClinical Study ID
NCT05662800
RG 2/2021
Ages 4-36 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- moderate or severe eczema and/or egg allergy,
- at least one complementary food already introduced,
- signed informed consent. Assessment of eczema severity: Eczema severity will be assessed based on the objectiveSCORing Atopic Dermatitis (SCORAD), use of topical steroids, calcineurin inhibitors orsystemic treatment as well as history of hospital admission. Definition of egg allergy: Participants with a documented IgE-mediated egg allergy will beidentified by a convincing history of a reaction in the presence of a positive skin pricktest (SPT) (wheal diameter of 3 mm or greater with egg white extract) or an SPT ≥ 5mm withno history of a reaction.
Exclusion
Exclusion Criteria:
- inability to withdraw antihistamines for at least 5 days prior to testing,
- use of prohibited medication such as beta-blockers, angiotensin-converting-enzymeinhibitors (ACE-I) and biological treatments affecting the immunological response,
- uncontrolled asthma or eczema which does not warrant readiness for a food challengewithin the study time frame,
- chronic urticaria,
- chronic systemic diseases.
Study Design
Total Participants: 240
Study Start date:
April 17, 2023
Estimated Completion Date:
April 30, 2025
Study Description
Connect with a study center
Department of Pediatric Pneumonology and Allergy, Medical University of Warsaw
Warsaw, Masovian 02-091
PolandActive - Recruiting
Department of Pediatrics, Allergology and Gastroenterology, Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University
Bydgoszcz, 85-067
PolandActive - Recruiting
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