Randomized Evaluation of Ten Allergy Skin Prick Test Devices

Asthma Clinical Trial

Official title:

Randomized Evaluation of Ten Allergy Skin Prick Test Devices

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03509766
• Other study ID #: NA_00092406
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: September 2015

Study information

• Verified date: August 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Rhinitis
• Rhinitis, Allergic
• Skin Testing

Intervention

Device:
• Histamine skin testing
skin testing using histamine

Locations

Country	Name	City	State
United States	John Hopkins Asthma and Allergy Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Skin Prick Techniques/Methodology Ratio	Compare 1mg/ml versus 6mg/ml histamine base for Duotip II twist method. Maximum wheal diameter is measured for each concentration.	15 minutes