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RecruitingNot ApplicableNCT05532566

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

Quercus Ilex and Quercus Robur Allergen Extracts. Determination of the in Vivo Allergenic Potency in Histamine Equivalent Units (HEP).

Sponsor

Inmunotek S.L.

Enrollment

30 participants

Start Date

Jan 24, 2023

Study Type

INTERVENTIONAL

Conditions

Allergic ReactionAllergic Skin ReactionAllergy Pollen

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

Min Age: 18 YearsMax Age: 64 Years

Inclusion Criteria6

  • 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 Criteria12

  • 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.

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Interventions

OTHERAllergenic 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.

Locations(1)

Clínica Subiza, centro de asma y alergia

Madrid, Spain

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NCT05532566