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Trial record 22 of 84669 for:    testing

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

Tracking Information
First Submitted Date  ICMJE December 27, 2013
First Posted Date  ICMJE April 26, 2018
Results First Submitted Date  ICMJE May 1, 2018
Results First Posted Date  ICMJE August 16, 2018
Last Update Posted Date August 16, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
  • 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%.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Determine the analytical sensitivity of ten allergy skin test devices [ Time Frame: 20 minutes ]
    A. Compare W/F response among devices using 1mm precision
  • Determine the analytical sensitivity of ten allergy skin test devices [ Time Frame: 20 minutes ]
    This will be done defining positive result threshold for each test device
  • Determine the analytical sensitivity of ten allergy skin test devices [ Time Frame: 20 minutes ]
    Report false positive and false negative rates using histamine and control
Change History Complete list of historical versions of study NCT03509766 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
  • Compare and contrast skin prick techniques and methodology [ Time Frame: 20 minutes ]
    Compare 4-lean technique versus manufacturer recommended method
  • Compare and contrast skin prick techniques and methodology [ Time Frame: 20 minutes ]
    Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method
  • Compare and contrast skin prick techniques and methodology [ Time Frame: 20 minutes ]
    Determine optimum skin testing site region on the upper arm vs. lower arm
  • Compare and contrast skin prick techniques and methodology [ Time Frame: 20 minutes ]
    Evaluate reproducibility of digital image versus direct measurement of wheal and flare
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: April 17, 2018)
  • Evaluate subjective performance of each skin prick device [ Time Frame: 20 minutes ]
    Determine pain scores using validated visual analogue scale (scale ranges 1-10, 10 being the most severe pain and 1 being no pain) B. Report technical ease of use and patient preference in an un-blinded fashion
  • Evaluate subjective performance of each skin prick device [ Time Frame: 20 minutes ]
    Report technical ease of use and patient preference in an un-blinded fashion
 
Descriptive Information
Brief Title  ICMJE Randomized Evaluation of Ten Allergy Skin Prick Test Devices
Official Title  ICMJE Randomized Evaluation of Ten Allergy Skin Prick Test Devices
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Allergic Rhinitis
  • Asthma
  • Food Allergy
  • Skin Testing
Intervention  ICMJE Device: Histamine skin testing
skin testing using histamine
Other Names:
  • skin test device
  • skin prick test device
Study Arms  ICMJE Experimental: Skin testing
All subject both allergic and non-allergic will be tested. There is only one (1) arm.
Intervention: Device: Histamine skin testing
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 17, 2018)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03509766
Other Study ID Numbers  ICMJE NA_00092406
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Johns Hopkins University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP