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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skin testing | Experimental | All subject both allergic and non-allergic will be tested. There is only one (1) arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Histamine skin testing | Device | skin testing using histamine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John Hopkins Asthma and Allergy Center | Baltimore | Maryland | 21224 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Skin Testing | All subjects both allergic and non-allergic will be tested. There is only one (1) arm. Histamine skin testing: skin testing using histamine |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | mm | 15 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adverse Events | no adverse events or reactions were reported. Events were recorded during the procedure and for 30 days following the procedure. Both serious and and non life threatening adverse vents were recorded. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jody Tversky | Johns Hopkins School of Medicine | 410-550-5949 | jodytversky@jhmi.edu |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D001249 | Asthma |
| D005512 | Food Hypersensitivity |
| D012220 | Rhinitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D012882 | Skin Tests |
| ID | Term |
|---|---|
| D007159 | Immunologic Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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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.
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
|
| 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%. | Posted | Number | percentage of tests true positive | 15 minutes |
|
|
|
| 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. | All 24 subjects received DuoTip II with both 1mg/ml and 6mg/ml histamine. This 24 vs 24 SPT in 24 total subjects. | Posted | Mean | Standard Deviation | ratio | 15 minutes |
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| 0 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
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| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |