Validation and Reproducibility of S.P.A.T. With Allergens

Hippocreates

Status: Completed

Conditions: Allergy to House Dust; Allergy Pollen

Treatments: Diagnostic Test: Skin Prick Manual Test; Device: Skin Prick Automated Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT05824637

1794559

Details and patient eligibility

About

To improve accuracy and take out human error opportunities, Hippo Dx developed S.P.A.T., an automated skin prick test. This study will provide a comparison between manual and automated skin prick test in allergic and non-allergic individuals with a panel of common inhalant allergens.

The primary endpoint is to compare the accuracy of S.P.A.T. to detect sensitization to common aeroallergens compared to a manual skin prick test (SPT).

It is a prospective monocentric study that will include 120 study participants.

Enrollment: 112 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Adults (18-65y) with presence or absence of self-reported symptoms of inhalant allergy will be included.

Exclusion criteria

• Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
• Use of antihistaminic medication < 7 days before the start of the study
• Use of tricyclic antidepressants (antihistamine activity) < 7 days before the start of the study
• Use of topical corticoids on the forearm < 7 days before the start of the study
• Use of Omalizumab < 6 months before the start of the study
• Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

Skin Prick Test

Other group

Description:

Study participants will receive a skin prick test by the skin prick automated test device on the right arm and manually by a health care provider on the left arm.

Treatment:

Device: Skin Prick Automated Test

Diagnostic Test: Skin Prick Manual Test