Ireland
--:--IST
Recruiting Not applicable

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

NCT05532566 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2023-01-24
Last updated
2025-05-01

Condition(s) studied

Allergic ReactionAllergic Skin ReactionAllergy Pollen

Investigational drug(s) / intervention(s)

Allergenic extract

Allergenic extract: In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm.

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion Criteria: * Subjects must live in a geographical area where allergic problems caused by Quercus ilex and Quercus robur are relevant. * Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Quercus ilex and Quercus robur. * A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen. * The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2. * Age: Between 18 and 64 years old. * Subjects must be able to give informed consent. Exclusion Criteria: * Subjects should not be excluded in terms of low or high sensitivity to Quercus ilex and Quercus robur. * Subjects outside the age range. * Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Quercus ilex and Quercus robur extracts. * Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is contraindicated. * Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test. * Subjects under treatment with ß-blockers. * Subjects clinically unstable (acute asthma, febrile, etc.). * Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives). * Subjects with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed. * Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.). * States of the subject in which he/she cannot offer cooperation and severe psychiatric disorders. * Pregnant women or women at risk of pregnancy and lactating women.

Primary outcome measure(s)

  • Size of the induced papule on the skin — 15 minutes
    Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.
  • Adverse reactions — 30 minutes
    Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.).

Trial sites (1)

FacilityCityRegionStatus
Clínica Subiza, centro de asma y alergia Madrid Spain Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05532566 on ClinicalTrials.gov ↗ ← All trials in Spain