Randomized Evaluation of Ten Allergy Skin Prick Test Devices

Not Applicable

Completed

• Conditions: Allergic Rhinitis; Asthma; Food Allergy; Skin Testing
• Interventions: Device: Histamine skin testing

• Registration Number: NCT03509766
• Lead Sponsor: Johns Hopkins University

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

Not available

Study Timeline

• Study First Submitted: 2013-12-27
• Study Start: 2014-01
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-26
• Results First Submitted: 2018-05-01
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-14
• Last Update Submitted: 2018-08-14
• Results First Posted: 2018-08-16
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Adults aged 18-65 with or without allergic disease

Exclusion Criteria

• severe concurrent illness
• uncontrolled asthma
• extensive eczema
• urticaria
• dermatographism
• pregnancy
• those taking antihistamines within the previous 10 days
• topical steroids
• immunomodulatory drugs
• long term use of oral steroids

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin testing	Histamine skin testing	All subject both allergic and non-allergic will be tested. There is only one (1) arm.

Primary Outcome Measures

Name	Time	Method
Wheal Response	15 minutes	Compare Wheal response among devices using 1mm precision. SPT test will be read at 15 min time point. The maximum wheal diameter will be recorded for each of ten skin prick devices. 3mm (and 2mm above negative control) qualify as a positive test.
Sensitivity	15 minutes	Sensitivity is calculated by dividing the true positive wheals divided by true positives plus false negatives and multiplying by 100. For example one false negative out of 24 tests equals a sensitivity of 95.8%.

Secondary Outcome Measures

Name	Time	Method
Skin Prick Techniques/Methodology Ratio	15 minutes	Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.

Trial Locations

Locations (1)

John Hopkins Asthma and Allergy Center; 🇺🇸 Baltimore, Maryland, United States