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

NCT05824637 | Completed

• 1 other identifier: 1794559
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergy to House Dust; Allergy Pollen

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.

  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.

  15 minutes after the diagnostic test

Study Arms (1)

Skin Prick Test

OTHER

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; Diagnostic Test: Skin Prick Manual Test

Interventions

Skin Prick Automated Test DEVICE

skin prick test to detection sensitisation to aeroallergens

Skin Prick Test

Skin Prick Manual Test DIAGNOSTIC_TEST

skin prick test to detection sensitisation to aeroallergens

Skin Prick Test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hippocreates: lead

Study Sites (1)

AZ Herentals

Herentals, 2200, Belgium

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Hendrik Sebrechts, MD

  AZ Herentals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: April 21, 2023
• Study Start: March 18, 2023
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)