Quercus Ilex and Quercus Robur Allergen Extracts Standardisation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorInmunotek S.L.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Allergenic extract
Other interventionIn 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Extract Q. ilex + extract Q. robur + positive control + negative controlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Size of the induced papule on the skin
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.
Time frame
15 minutes2
Adverse reactions
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.).
Time frame
30 minutesSponsors and contacts
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Source ClinicalTrials.gov