Ignite Creation Date:
2025-12-24 @ 4:26 PM
Ignite Modification Date:
2026-01-04 @ 10:43 PM
Study NCT ID:
NCT03509766
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2013-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Evaluation of Ten Allergy Skin Prick Test Devices
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Randomized Evaluation of Ten Allergy Skin Prick Test Devices
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
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:
None
Brief Summary:
The goal of this study is to compare ten current and readily available FDA approved allergy skin prick devices to determine the most sensitive and specific product and methods used for the diagnosis of allergic disease. The primary outcome will be to determine the analytical sensitivity and specificity of all ten skin prick devices by measuring wheal and flare response to histamine and control diluent in 1mm increments. Secondary outcomes include comparison of skin prick technique, optimum histamine concentration, patient comfort, reproducibility, and the comparability of high-resolution digital images.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: