Determination of Blomia Tropicalis Allergen Extract in Prick Test Units
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorInmunotek S.L.
About this trial
The primary objective is to assess the concentration of Blomia tropicalis allergenic extract that induces a wheal of size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution, in order to be used as in-house reference preparation (IHRP).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female or male aged 18 to 64 years, both included.
Subjects who have signed and dated the informed consent form.
Subjects must reside in a geographical area where allergic problems caused by Blomia tropicalis are relevant.
Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Blomia tropicalis
Disqualifiers
Subjects outside the age range.
Subjects who have previously received immunotherapy within the last 5 years for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Blomia tropicalis extract.
Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.
Subjects who have previously exhibited a severe adverse reaction during diagnostic skin prick tests.
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 the allergenic extract, in addition to the positive control (histamine) and the negative control, will be applied. The application will be duplicated on the subject's anterior forearm, with a distance of approximately 4 cm between each application to avoid overlapping reactions and false-positives results.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Extract B. tropicalis + 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 minutesSecondary outcomes
1
Adverse reactions
The secondary outcome is to assess the safety and tolerability of Blomia tropicalis extract. Mild side reactions such as pruritus, erythema, local oedema may occur during the diagnostic skin test by prick test. There is a risk, albeit rare and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock) (28) (urticaria, asthma, anaphylactic shock, etc.).
Time frame
30 minutesSponsors and contacts
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Source ClinicalTrials.gov
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