Determination of Blomia Tropicalis Allergen Extract in Prick Test Units (NCT07195929) | Clinical Trial Compass
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Determination of Blomia Tropicalis Allergen Extract in Prick Test Units
Spain30 participantsStarted 2025-11
Plain-language summary
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).
Who can participate
Age range18 Years – 64 Years
SexALL
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Inclusion criteria
✓. 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
✓. A positive prick-test (mean wheal diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against complete extract or any molecular component to the allergenic source.
✓. The area of the wheal obtained with 10 mg/mL histamine dihydrochloride should be ≥ 7 mm², which corresponds to a mean wheal diameter ≥ 3 mm.
✓. The area of the wheal obtained with negative control should be \< 7 mm², which corresponds to a mean wheal diameter \< 3 mm.
✓. Women of childbearing age (i.e following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilization methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must present a negative urine pregnancy test at the time of enrollment in the trial, as well as a confirmed menstrual period.
Exclusion criteria
✕. 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.
✕. Subjects on treatment with ß-blockers.
✕. Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines) (See Section 5.2).
✕. 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).