Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators
Completed · Not applicable
Conditions studied: Allergy, Hypersensitivity, Immediate, Ig-E Mediated Food
In brief
This clinical study, titled "Head-to-Head Comparison Study between Different FDA Registered Allergy Skin Test Applicators," aims to compare the reliability and clinical performance of three skin prick test (SPT) devices: Allertest™ Multiple Skin Test Applicator, Lincoln Multi-Test II, and Greer Skintestor OMNI Applicator. The primary objective is to evaluate the consistency and accuracy of these devices in allergy testing.
Key facts
- Study ID
- NCT07400718
- Run by
- QHSLab, Inc.
- People needed
- 30
- Starts
- 2025-11-12
- Expected to finish
- 2026-01-30
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients will be entered into this study only if they meet all of the following criteria:
- Written and signed informed consent obtained before starting any protocol-specific procedures.
- Subjects willing to withhold antihistamines, Leukotriene antagonists and H2 antagonists for at least 1 week before testing to avoid masking the histamine reactions on the skin.
- Male or female between 18 to 60 65 years, inclusive.
- Ability to comply with the study procedures and visit schedule.
You may not qualify if…
- Patients will NOT be entered into this study if they meet any of the following criteria:
- Anaphylactic reaction (constitutional) after the previous skin test with the same allergen
- Acute fever
- Systemic disease with acute manifestation or decompensation
- Abnormal skin condition in the area to be tested (such as eczema sunburn condition after sunbathing)
- Pregnancy
- Presence of dermatographism, severe atopic dermatitis, or use of tricyclic antidepressants.
- Current use of beta-blockers
- Known hypersensitivity to any component of the test solutions (histamine or glycerin).
- Participation in another clinical study within 30 days before enrollment. Participation in another clinical study within 30 days before enrollment.
Where it is running
- QHS Health center — Miami, Florida, United States
Full record on ClinicalTrials.gov
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