Allergic Rhinitis, Asthma, Food Allergy, Skin Testing
Conditions
Keywords
allergic, rhinitis, allergy, asthma, food allergy, skin testing, skin prick test
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.
Interventions
DEVICEHistamine skin testing
skin testing using histamine
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
Neither the subject nor the technician are masked as to which device is being placed. However, the investigator who reads the skin prick test results is blinded as to which device is which.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Skin Testing All subject both allergic and non-allergic will be tested. There is only one (1) arm.
Histamine skin testing: skin testing using histamine | 24 |
| Total | 24 |
Baseline characteristics
| Characteristic | Skin Testing |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Sex/Gender, Customized Female | 18 Participants |
| Sex/Gender, Customized Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 24 |
| other Total, other adverse events | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 |
Outcome results
Primary
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%.
Time frame: 15 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Skin Testing | Sensitivity | 95.8 percentage of tests true positive |
Primary
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.
Time frame: 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin Testing | Wheal Response | 6.8 mm | Standard Deviation 0.4 |
Secondary
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.
Time frame: 15 minutes
Population: All 24 subjects received DuoTip II with both 1mg/ml and 6mg/ml histamine. This 24 vs 24 SPT in 24 total subjects.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Skin Testing | Skin Prick Techniques/Methodology Ratio | 1 ratio | Standard Deviation 0.01 |