Randomized Evaluation of Ten Allergy Skin Prick Test Devices

Study Overview
=================
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.

Official Title
-----------------
Randomized Evaluation of Ten Allergy Skin Prick Test Devices

Conditions
-----------------
Allergic Rhinitis, Asthma, Food Allergy, Skin Testing

Intervention / Treatment
-----------------
* Device: Histamine skin testing


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin testing<br>All subject both allergic and non-allergic will be tested. There is only one (1) arm. | Device: Histamine skin testing<br>* skin testing using histamine<br>* Other names: skin prick test device;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheal Response | 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. | 15 minutes | 
| Sensitivity | 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%. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin Prick Techniques/Methodology Ratio | Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration. | 15 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergic, rhinitis, allergy, asthma, food allergy, skin testing, skin prick test