Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

Recruiting now · Not applicable

Conditions studied: Allergic Reaction, Allergic Skin Reaction, Allergy Pollen

In brief

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).

Key facts

Study ID

NCT05532566

Run by

Inmunotek S.L.

People needed

30

Starts

2023-01-24

Expected to finish

2025-11-30

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Clínica Subiza, centro de asma y alergia — Madrid, Spain (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.