Actively Recruiting

Phase Not Applicable
Age: 18Years - 64Years
All Genders
NCT05532566

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

Led by Inmunotek S.L. · Updated on 2025-05-01

30

Participants Needed

1

Research Sites

148 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

CONDITIONS

Official Title

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

Who Can Participate

Age: 18Years - 64Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must live in an area where allergies from Quercus ilex and Quercus robur are common.
  • Have a positive history of inhalant allergy symptoms like rhinitis, rhinoconjunctivitis, or asthma due to these allergens.
  • Show a positive skin prick test with a papule diameter of at least 3 mm for the allergen and/or have specific IgE against it.
  • Have a mean papule area of at least 7 mm2 from histamine dichlorhydrate at 10 mg/mL.
  • Be between 18 and 64 years old.
  • Be able to provide informed consent.
Not Eligible

You will not qualify if you...

  • Subjects outside the age range of 18 to 64 years.
  • Those who have had immunotherapy in the last 5 years for asthma or allergic rhinoconjunctivitis that might affect testing.
  • Subjects with severe allergy symptoms where stopping systemic antihistamines is unsafe.
  • Those who had severe reactions to previous skin prick tests.
  • Subjects currently on beta-blocker treatment.
  • Those who are clinically unstable, such as having acute asthma or fever.
  • Subjects with active skin conditions like urticaria, severe dermographism, atopic dermatitis, sunburn, eczema, or psoriasis on the test site.
  • Those with active herpes simplex or varicella zoster infections at the test site.
  • Subjects with conditions where adrenaline use is unsafe, like hyperthyroidism, high blood pressure, or heart disease.
  • Individuals unable to cooperate or with severe psychiatric disorders.
  • Pregnant, breastfeeding, or women at risk of pregnancy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Clínica Subiza, centro de asma y alergia

Madrid, Spain

Actively Recruiting

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Research Team

M

Miguel Casanovas, MD

CONTACT

R

Raquel Caballero, BSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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