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

Validation and Reproducibility of Type I Hypersensitivity Reaction in the Diagnostic Process of the Skin Prick Test in Allergic and Non-allergic Individuals

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.

Study Overview

• Status: Completed
• Conditions: Allergy Pollen; Allergy to House Dust
• Intervention / Treatment: Device: Skin Prick Automated Test; Diagnostic test: Skin Prick Manual Test

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Herentals, Belgium, 2200
    • AZ Herentals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Skin Prick Automated Test; skin prick test to detection sensitisation to aeroallergens; Diagnostic test: Skin Prick Manual Test; skin prick test to detection sensitisation to aeroallergens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.	Each of the allergens are pricked three times via manual and automated skin prick test. Three positive or negative test results are considered consistent whereas either one or two positive or negative test results are considered non-consistent resulting in an inconclusive test result.	15 minutes after the diagnostic test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.	Visual analogue scale (0: best - 10: worse)	day of the diagnostic test
Time (seconds) required to run an automated versus a manual skin prick test.		during the diagnostic test
Amount of allergen solution that is required to run an automated versus a manual skin prick test.		during the diagnostic test
Level of discomfort experienced by the patient as assessed by visual analogue scale after an automated versus a manual skin prick test.	Visual analogue scale (0: best - 10: worse)	15 minutes after the diagnostic test

Collaborators and Investigators

• Sponsor: Hippocreates
• Investigators: Principal Investigator: Hendrik Sebrechts, MD, AZ Herentals

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2023
• Primary Completion (Actual): April 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): April 21, 2023

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Nose Diseases; Rhinitis, Allergic; Rhinitis; Hypersensitivity; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: 1794559

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No