Randomized Evaluation of Ten Allergy Skin Prick Test Devices
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 27, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
April 26, 2018
CompletedResults Posted
Study results publicly available
August 16, 2018
CompletedAugust 16, 2018
August 1, 2018
1.7 years
December 27, 2013
May 1, 2018
August 14, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Skin Prick Techniques/Methodology Ratio
15 minutes
Study Arms (1)
Skin testing
EXPERIMENTALAll subject both allergic and non-allergic will be tested. There is only one (1) arm.
Interventions
skin testing using histamine
Eligibility Criteria
You may qualify if:
- Adults aged 18-65 with or without allergic disease
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
John Hopkins Asthma and Allergy Center
Baltimore, Maryland, 21224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jody Tversky
- Organization
- Johns Hopkins School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- 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.
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 27, 2013
First Posted
April 26, 2018
Study Start
January 1, 2014
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
August 16, 2018
Results First Posted
August 16, 2018
Record last verified: 2018-08