NCT06803953

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

Definition of a Cut Off Value for S.P.A.T (Skin Prick Automated Test) Device Corresponding With Sensitisation to Both Birch and House Dust Mite Allergens, in Allergic Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Hippocreates · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2024-09-17
• Primary completion: 2024-10-21
• Completion: 2024-10-21
• First posted: 2025-01-31
• Last updated: 2025-01-31

Locations

1 site across 1 country: France