CompletedNot Applicable

Head-to-Head Comparison Study Between Different FDA Registered Allergy Skin Test Applicators

United States30 participantsStarted 2025-11-12

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

Exclusion 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).

What they're measuring

Pain Assessment Using Visual Analog Scale (VAS)

Timeframe: Immediately after device application (within 1 minute of skin test procedure)

Sensitivity (Histamine Positive Control Performance)

Timeframe: 15 minutes after device application

Specificity (Glycerin Negative Control Performance)

Timeframe: 15 minutes after device application

Trial details

NCT IDNCT07400718

SponsorQHSLab, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-30

View on ClinicalTrials.gov More Allergy trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

Exclusion 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).

What they're measuring

Pain Assessment Using Visual Analog Scale (VAS)

Timeframe: Immediately after device application (within 1 minute of skin test procedure)

Sensitivity (Histamine Positive Control Performance)

Timeframe: 15 minutes after device application

Specificity (Glycerin Negative Control Performance)

Timeframe: 15 minutes after device application