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Evaluation of an Adjusted Cutoff Value for S.P.A.T (Skin Prick Automated Test) Device in Allergic Subjects

NCT06803953 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-01-31

No results posted yet for this study

Summary

Skin prick test (SPT) is a first line diagnostic test to detect type I hypersensitivity in patients suspected of an inhalant allergy. A novel S.P.A.T. or Skin Prick Automated Test device has been developed to enable more standardised allergy testing. In two independent studies, Gorris and colleagues previously showed that test results after S.P.A.T. are less variable and more consistent compared to conventional skin prick testing (Gorris et al. Allergy. 2023; Seys et al. Rhinology 2024). In these studies conducted in volunteers, a cutoff value of 4.5 mm has been proposed based on the 97.5 percentile level of glycerol control wheals.

The current study aims to determine a cutoff value corresponding to the highest accuracy to discriminate between sensitized-allergic and non sensitized, non allergic subjects for both house dust mite and birch allergens.

Conditions

  • House Dust Mite Allergy
  • Birch Pollen Allergy

Interventions

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

DIAGNOSTIC_TEST

Nasal Allergen Challenge

nasal allergen challenge with either house dust mite allergens or birch pollen allergens

Sponsors & Collaborators

  • Alyatec

    collaborator INDUSTRY

  • Hippocreates

    lead INDUSTRY

Principal Investigators

  • Alina Gherasim, MD · Alyatec

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2024-10-21
Completion
2024-10-21

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06803953 on ClinicalTrials.gov