Randomized Evaluation of Ten Allergy Skin Prick Test Devices
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|ClinicalTrials.gov Identifier: NCT03509766|
Recruitment Status : Completed
First Posted : April 26, 2018
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Asthma Food Allergy Skin Testing||Device: Histamine skin testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Official Title:||Randomized Evaluation of Ten Allergy Skin Prick Test Devices|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2015|
Experimental: Skin testing
All subject both allergic and non-allergic will be tested. There is only one (1) arm.
Device: Histamine skin testing
skin testing using histamine
- Wheal Response [ Time Frame: 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 [ Time Frame: 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%.
- Skin Prick Techniques/Methodology Ratio [ Time Frame: 15 minutes ]Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03509766
|United States, Maryland|
|John Hopkins Asthma and Allergy Center|
|Baltimore, Maryland, United States, 21224|