Randomized Evaluation of Ten Allergy Skin Prick Test Devices

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergic Rhinitis Asthma Food Allergy Skin Testing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

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.

Study Groups

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Skin testing

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

Group Type EXPERIMENTAL

Histamine skin testing

Intervention Type DEVICE

skin testing using histamine

Interventions

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Histamine skin testing

skin testing using histamine

Intervention Type DEVICE

Other Intervention Names

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skin test device skin prick test device

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes