Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Randomized Evaluation of Ten Allergy Skin Prick Test Devices

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Investigator);   Primary Purpose: Diagnostic
Conditions Allergic Rhinitis
Asthma
Food Allergy
Skin Testing
Intervention Device: Histamine skin testing
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Skin Testing
Hide Arm/Group Description

All subjects both allergic and non-allergic will be tested. There is only one (1) arm.

Histamine skin testing: skin testing using histamine

Period Title: Overall Study
Started 24
Completed 24
Not Completed 0
Arm/Group Title Skin Testing
Hide Arm/Group Description

All subject both allergic and non-allergic will be tested. There is only one (1) arm.

Histamine skin testing: skin testing using histamine

Overall Number of Baseline Participants 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
<=18 years
0
   0.0%
Between 18 and 65 years
24
 100.0%
>=65 years
0
   0.0%
Sex/Gender, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants
Male
6
  25.0%
Female
18
  75.0%
1.Primary Outcome
Title Wheal Response
Hide Description 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.
Time Frame 15 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Skin Testing
Hide Arm/Group Description:

All subjects both allergic and non-allergic will be tested. There is only one (1) arm.

Histamine skin testing: skin testing using histamine

Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: mm
6.8  (0.4)
2.Primary Outcome
Title Sensitivity
Hide Description 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%.
Time Frame 15 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Skin Testing
Hide Arm/Group Description:

All subjects both allergic and non-allergic will be tested. There is only one (1) arm.

Histamine skin testing: skin testing using histamine

Overall Number of Participants Analyzed 24
Measure Type: Number
Unit of Measure: percentage of tests true positive
95.8
3.Secondary Outcome
Title Skin Prick Techniques/Methodology Ratio
Hide Description Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.
Time Frame 15 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
All 24 subjects received DuoTip II with both 1mg/ml and 6mg/ml histamine. This 24 vs 24 SPT in 24 total subjects.
Arm/Group Title 1 Versus 6mg
Hide Arm/Group Description:
1 versus 6mg histamine
Overall Number of Participants Analyzed 24
Mean (Standard Deviation)
Unit of Measure: ratio
1  (.01)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adverse Events
Hide Arm/Group Description 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.
All-Cause Mortality
Adverse Events
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Adverse Events
Affected / at Risk (%)
Total   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Adverse Events
Affected / at Risk (%)
Total   0/24 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Jody Tversky
Organization: Johns Hopkins School of Medicine
Phone: 410-550-5949
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03509766     History of Changes
Other Study ID Numbers: NA_00092406
First Submitted: December 27, 2013
First Posted: April 26, 2018
Results First Submitted: May 1, 2018
Results First Posted: August 16, 2018
Last Update Posted: August 16, 2018