Randomized Evaluation of Ten Allergy Skin Prick Test Devices

Johns Hopkins University

Status: Completed

Conditions: Food Allergy; Asthma; Skin Testing; Allergic Rhinitis

Treatments: Device: Histamine skin testing

Study type: Interventional

Funder types: Other

Identifiers

NCT03509766

NA_00092406

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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24 participants in 1 patient group

Skin testing

Experimental group

Description:

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

Treatment:

Device: Histamine skin testing