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

Allergy Pollen Clinical Trial

Official title:

Validation and Reproducibility of Type I Hypersensitivity Reaction in the Diagnostic Process of the Skin Prick Test in Allergic and Non-allergic Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05824637
• Other study ID #: 1794559
• Status: Completed
• Phase: N/A
• Start date: March 18, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2023
• Source: Hippocreates
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: June 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Allergy Pollen
• Allergy to House Dust
• Hypersensitivity
• Rhinitis, Allergic, Seasonal

Intervention

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

Locations

Country	Name	City	State
Belgium	AZ Herentals	Herentals

Sponsors (1)

Lead Sponsor	Collaborator
Hippocreates

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.	Visual analogue scale (0: best - 10: worse)	day of the diagnostic test
Secondary	Time (seconds) required to run an automated versus a manual skin prick test.		during the diagnostic test
Secondary	Amount of allergen solution that is required to run an automated versus a manual skin prick test.		during the diagnostic test
Secondary	Level of discomfort experienced by the patient as assessed by visual analogue scale after an automated versus a manual skin prick test.	Visual analogue scale (0: best - 10: worse)	15 minutes after the diagnostic test