Validation and Reproducibility of Type I Hypersensitivity Reaction in the Diagnostic Process of the Skin Prick Test in Allergic and Non-allergic Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hippocreates
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Skin Prick Test
Study participants will receive a skin prick test by the skin prick automated test device on the right arm and manually by a health care provider on the left arm.
Intervention: Skin Prick Manual Test (Diagnostic Test)
Skin Prick Test
Study participants will receive a skin prick test by the skin prick automated test device on the right arm and manually by a health care provider on the left arm.
Intervention: Skin Prick Automated Test (Device)
Outcomes
Primary Outcomes
Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.
Time Frame: 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 Outcomes
- Amount of allergen solution that is required to run an automated versus a manual skin prick test.(during the diagnostic test)
- Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.(day of the diagnostic test)
- Time (seconds) 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)