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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05824637
Other study ID # 1794559
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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