Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for representative common inhalant allergens to conventional SPT in terms of wheal reaction positivity and overall safety. Tests are performed in patients who have a medical history of relevant allergic rhinitis to any of the tested allergens.
An open-label, single site bridging study. Subjects with a history of in-halation allergies will be tested in parallel with the SPT Tape and with the conventional SPT procedure using one forearm each. In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is applied on the two forearms one time only. The following Soluprick® allergens and control solutions will be evaluated: Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus, D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the same location and order on both arms.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
75
Skin Prick Testing with inhalant allergens
Skin Prick Testing with a Tape, integrating the allergens and needles
Wheal diameters
Maximal wheal diameter in millimeter
Time frame: 15 min
Visual Analogue Scale on Comfort
Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"
Time frame: 30 min
Patient' s preference
Patients are asked to select the test they would prefer
Time frame: 30 min
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