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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin Prick Test TAPE | Active Comparator | The Skin Prick Test Tape is an innovative sterile "all-in" drug carrying 8 allergens and 2 control solutions including prick needles in one Tape for easy use and standardization. Single use. Reading of wheal reactions after 15 minutes, facilitated by stripes with the allergen names. |
|
| Skin Prick Test | Active Comparator | The conventional SPT is the world-wide standard in allergy Type 1 diagnosis for inhalant and food allergens. Drops of allergens are applied to the forearm and, with the help of a lancet, brought into the skin. Reading of wheal reactions after 15 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin Prick Test | Diagnostic Test | Skin Prick Testing with inhalant allergens |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Wheal diameters | Maximal wheal diameter in millimeter | 15 min |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale on Comfort | Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant" | 30 min |
| Patient' s preference | Patients are asked to select the test they would prefer |
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Inclusion Criteria:
Subjects will be included only, if
Exclusion Criteria:
Subjects may not be included, if
they are impaired in understanding nature, meaning, and the scope of the study, or are incapable of giving written informed consent,
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claus U Bachert, MD | Contact | +32473310902 | claus.bachert@ugent.be |
| Name | Affiliation | Role |
|---|---|---|
| Martin Wagenmann, MD | University pf Düsseldorf, Germany | Principal Investigator |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D003233 | Conjunctivitis, Allergic |
| D005512 | Food Hypersensitivity |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D010328 | Patch Tests |
| ID | Term |
|---|---|
| D012882 | Skin Tests |
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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Comparison of conventional Skin Prick Test vs. Tape SPT
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| Skin Prick Test TAPE |
| Diagnostic Test |
Skin Prick Testing with a Tape, integrating the allergens and needles |
|
| 30 min |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |