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

Not Applicable

Completed

• Conditions: Allergy to House Dust; Allergy Pollen
• Interventions: Device: Skin Prick Automated Test; Diagnostic Test: Skin Prick Manual Test

• Registration Number: NCT05824637
• Lead Sponsor: Hippocreates

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-30
• Study Start: 2023-03-18
• Study First Submitted QC: 2023-04-20
• Study First Posted: 2023-04-21
• Primary Completion: 2023-04-30
• Study Completion: 2023-06-30
• Status Verified: 2023-07
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Skin Prick Test	Skin Prick Manual 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.
Skin Prick Test	Skin Prick Automated 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.

Primary Outcome Measures

Name	Time	Method
Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.	15 minutes after the diagnostic 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AZ Herentals; 🇧🇪 Herentals, Belgium