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

NCT06803953 | Completed

• 1 other identifier: HIP-001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cutoff value with highest accuracy based on longest wheal diameter after SPAT

  The cutoff value that corresponds to the highest F1 score of the accuracy of S.P.A.T. to detect sensitisation to both house dust mite and birch allergens by measuring the longest diameter of wheal size.

  15 minutes after SPAT

Secondary Outcomes (1)

• Accuracy of SPAT compared to conventional SPT

  15 minutes after SPAT

Other Outcomes (9)

• Intensity of allergy symptoms

  15 minutes after SPAT

• Intensity of allergy symptoms

  15 minutes after SPAT

• Longest wheal diameter measurement through S.P.A.T. web viewer compared to conventional ruler-based measurement

  15 minutes after SPAT

Study Arms (3)

HDM allergic patients

EXPERIMENTAL

HDM allergic patients receive a nasal allergen provocation test with house dust mite allergens (der p and der f) to confirm the clinical relevance of the allergy. All patients receive a conventional skin prick test on the one arm and an automated test on the other arm.

Device: Skin Prick Automated Test; Diagnostic Test: Skin Prick Manual Test; Diagnostic Test: Nasal Allergen Challenge

Birch pollen allergic patients

EXPERIMENTAL

Birch pollen allergic patients receive a nasal allergen provocation test with birch allergen (bet v) to confirm the clinical relevance of the allergy. All patients receive a conventional skin prick test on the one arm and an automated test on the other arm.

Device: Skin Prick Automated Test; Diagnostic Test: Skin Prick Manual Test; Diagnostic Test: Nasal Allergen Challenge

Non allergic patients

EXPERIMENTAL

Non allergic patients did not receive a nasal allergen provocation test. All patients receive a conventional skin prick test on the one arm and an automated test on the other 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

Birch pollen allergic patients; HDM allergic patients; Non allergic patients

Skin Prick Manual Test DIAGNOSTIC_TEST

skin prick test to detection sensitisation to aeroallergens

Birch pollen allergic patients; HDM allergic patients; Non allergic patients

Nasal Allergen Challenge DIAGNOSTIC_TEST

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

Birch pollen allergic patients; HDM allergic patients

Eligibility Criteria

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

You may qualify if:

• Provide informed consent signed by study patient and investigator;
• Subjects with Health Social Identification Number;
• Allergic subjects with rhinitis with or without asthma and with or without conjunctivitis symptoms with proof of sensitisation to an inhalant allergy, either house dust mite ( Dermatophagoides pteronyssinus) or birch pollen by a positive skin prick test (SPT) with a wheal diameter ≥3 mm as compared to negative control. The clinical response against the culprit allergen will be assessed by a positive nasal allergen provocation test. (patients must not have clinical symptoms corresponding to both sensitization).
• Non-allergic subjects with proof of lack of sensitisation to any of the above referred allergens by a negative conventional skin prick test less than 2 years.
• Normal lung function as judged by investigator with FEV 1 and FEV 1/FVC ≥ 70% of predicted
• Willing and able to comply with clinic visits and study-related procedures;
• Able to understand and complete study-related questionnaires.

You may not qualify if:

• Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment;
• Any skin abnormalities, which could negatively - in the opinion of the investigator - affect the test results, including large scars and tattoos on the forearm ;
• Patients with clinical symptoms corresponding to both sensitization to birch and house dust mite
• 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 (on the forearm) or systemic corticoids \< 7 days before the start of the study;
• Use of any monoclonal antibodies such as omalizumab, dupilumab, mepolizumab \< 6 months before the start of the study;
• Use of oral systemic corticosteroids within 4 weeks prior to screening
• Use of intramuscular systemic corticosteroids within 3 months prior to screening
• Use of allergen immunotherapy for the allergen tested (\<2 y) or another inhalant allergen;
• Pregnancy or breastfeeding;
• Incapacitated subjects;
• Subjects who do not speak the local language (French);
• Subjects who cannot read or write.

Sponsors & Collaborators

• Hippocreates: lead
• Alyatec: collaborator

Study Sites (1)

Alyatec

Strasbourg, 67000, France

Location

MeSH Terms

Conditions

Dust Mite Allergy

Condition Hierarchy (Ancestors)

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

Study Officials

• Alina Gherasim, MD

  Alyatec

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 31, 2025
• Study Start: September 17, 2024
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

FR (1)