Ignite Creation Date:
2024-05-06 @ 12:43 PM
Last Modification Date:
2024-10-26 @ 1:02 PM
Study NCT ID:
NCT03820154
Status:
UNKNOWN
Last Update Posted:
2019-01-29
First Post:
2018-09-23
Brief Title:
Diagnostic Equivalence of the Skin Prick Test Tape vs Conventional Skin PrickTest
Sponsor:
Prof Dr Claus Bachert BVBA
Organization:
Prof Dr Claus Bachert BVBA
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPTTapeD1
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None