Allergy to House Dust, Allergy Pollen
Conditions
Brief 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.
Interventions
skin prick test to detection sensitisation to aeroallergens
DIAGNOSTIC_TESTSkin Prick Manual Test
skin prick test to detection sensitisation to aeroallergens
Sponsors
Hippocreates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test. | 15 minutes after the diagnostic 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result. | day of the diagnostic test | Visual analogue scale (0: best - 10: worse) |
| Time (seconds) required to run an automated versus a manual skin prick test. | during the diagnostic test | — |
| Amount of allergen solution that is required to run an automated versus a manual skin prick test. | during the diagnostic test | — |
| Level of discomfort experienced by the patient as assessed by visual analogue scale after an automated versus a manual skin prick test. | 15 minutes after the diagnostic test | Visual analogue scale (0: best - 10: worse) |
Countries
Belgium
Outcome results
None listed