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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
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Asthma Food Allergy Skin Testing Device: Histamine skin testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
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.
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
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
Other Names:
  • skin test device
  • skin prick test device




Primary Outcome Measures :
  1. 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.

  2. 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%.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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United States, Maryland
John Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03509766     History of Changes
Other Study ID Numbers: NA_00092406
First Posted: April 26, 2018    Key Record Dates
Results First Posted: August 16, 2018
Last Update Posted: August 16, 2018
Last Verified: August 2018

Keywords provided by Johns Hopkins University:
allergic
rhinitis
allergy
asthma
food allergy
skin testing
skin prick test

Additional relevant MeSH terms:
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Rhinitis
Hypersensitivity
Rhinitis, Allergic
Food Hypersensitivity
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Immune System Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs