Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest (SPTTapeD1)
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|ClinicalTrials.gov Identifier: NCT03820154|
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Allergic Asthma Allergic Conjunctivitis Food Allergy||Diagnostic Test: Skin Prick Test Diagnostic Test: Skin Prick Test TAPE||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Comparison of conventional Skin Prick Test vs. Tape SPT|
|Masking:||None (Open Label)|
|Official Title:||A Bridging Study Investigating the Diagnostic Equivalence of the SPT Tape in Comparison With the Conventional SPT Using ALK SoluprickR Allergen Extracts in Patients With Inhalation Allergy|
|Estimated Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||July 30, 2019|
Active Comparator: Skin Prick Test TAPE
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.
Diagnostic Test: Skin Prick Test TAPE
Skin Prick Testing with a Tape, integrating the allergens and needles
Active Comparator: Skin Prick Test
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.
Diagnostic Test: Skin Prick Test
Skin Prick Testing with inhalant allergens
- Wheal diameters [ Time Frame: 15 min ]Maximal wheal diameter in millimeter
- Visual Analogue Scale on Comfort [ Time Frame: 30 min ]Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"
- Patient' s preference [ Time Frame: 30 min ]Patients are asked to select the test they would prefer
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820154
|Contact: Claus U Bachert, MDemail@example.com|
|Principal Investigator:||Martin Wagenmann, MD||University pf Düsseldorf, Germany|