Allergic Asthma, Allergic Conjunctivitis, Allergic Rhinitis, Food Allergy
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTSkin Prick Test
Skin Prick Testing with inhalant allergens
DIAGNOSTIC_TESTSkin Prick Test TAPE
Skin Prick Testing with a Tape, integrating the allergens and needles
Sponsors
Prof. Dr. Claus Bachert BVBA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Comparison of conventional Skin Prick Test vs. Tape SPT
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects will be included only, if 1. they were informed about the nature, meaning, and scope of the study, and if they provided written consent to their participation 2. they are at least 18 years of age, 3. they have a history of allergic rhinitis due to grass and/or birch pollen, house dust mites, mugwort, cat and/or dog dander, and/or Alternaria since 2 years or more
Exclusion criteria
* Subjects may not be included, if 1. they are impaired in understanding nature, meaning, and the scope of the study, or are incapable of giving written informed consent, 2. they suffer from diseases, show other conditions, or take medications, which might impact the skin tests or might contradict the correct conduct and evaluation of the study. In particular this includes the following: 1. acute allergy, 2. history of systemic reactions or hypersensitivity to allergens, abuse of drugs or alcohol 3. severe diseases, 4. impaired reactivity of the skin (e.g. hyperkeratosis, ichthyosis, urticaria factitia) and acute chronic eczema in the skin test areas, skin infections, 5. pregnancy or nursing, 6. treatment with β-blockers, 7. treatment with antihistamines or systemic glucocorticoids during the last 4 weeks, with astemizol during the last 12 weeks, 8. treatment with tricyclic antidepressants benzodiazepines, and neuroleptic drugs which may have histamine-antagonistic effects during the last 2 weeks, 9. participation in any other medication study at the study time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wheal diameters | 15 min | Maximal wheal diameter in millimeter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale on Comfort | 30 min | Visual Analogue Scale from 0-10 cm from not at all unpleasant to very unpleasant |
| Patient' s preference | 30 min | Patients are asked to select the test they would prefer |
Contacts
Primary ContactClaus U Bachert, MD
Outcome results
None listed