NCT05532566 Quercus Ilex and Quercus Robur Allergen Extracts Standardisation
| NCT ID | NCT05532566 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inmunotek S.L. |
| Condition | Allergic Reaction |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-01-24 |
| Primary Completion | 2025-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-01-24 with a primary completion date of 2025-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Javier Subiza, MD
PRINCIPAL INVESTIGATOR
Clinica Subiza, centro de asma y alergia
Frequently Asked Questions
Who can join the NCT05532566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Allergic Reaction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05532566 currently recruiting?
Yes, NCT05532566 is actively recruiting participants. Contact the research team at mcasanovas@inmunotek.com for enrollment information.
Where is the NCT05532566 trial being conducted?
This trial is being conducted at Madrid, Spain.
Who is sponsoring the NCT05532566 clinical trial?
NCT05532566 is sponsored by Inmunotek S.L.. The principal investigator is Javier Subiza, MD at Clinica Subiza, centro de asma y alergia. The trial plans to enroll 30 participants.