N/A
Completed N=24
Randomized Evaluation of Ten Allergy Skin Prick Test Devices
Source: ClinicalTrials.gov NCT03509766 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2018
Primary outcomePrimary: Wheal Response — 6.8 mm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wheal Response |
6.8 | — |
| PRIMARY Sensitivity |
95.8 | — |
| SECONDARY Skin Prick Techniques/Methodology Ratio |
1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03509766). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.