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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-18

Study Completion Date

2023-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Allergy to House Dust Allergy Pollen

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Skin Prick Test

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.

Group Type OTHER

Skin Prick Automated Test

Intervention Type DEVICE

skin prick test to detection sensitisation to aeroallergens

Skin Prick Manual Test

Intervention Type DIAGNOSTIC_TEST

skin prick test to detection sensitisation to aeroallergens

Interventions

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Skin Prick Automated Test

skin prick test to detection sensitisation to aeroallergens

Intervention Type DEVICE

Skin Prick Manual Test

skin prick test to detection sensitisation to aeroallergens

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes