Back to resultsValidation and Reproducibility of S.P.A.T. With Allergens
Primary Purpose
Allergy to House Dust, Allergy Pollen
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Skin Prick Automated Test
Skin Prick Manual Test
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergy to House Dust
Eligibility Criteria
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)
Sites / Locations
- AZ Herentals
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Skin Prick Test
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.
Visual analogue scale (0: best - 10: worse)
Time (seconds) required to run an automated versus a manual skin prick test.
Amount of allergen solution that is required to run an automated versus a manual skin prick test.
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05824637
Brief Title
Validation and Reproducibility of S.P.A.T. With Allergens
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 18, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hippocreates
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy to House Dust, Allergy Pollen
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Skin Prick Test
Arm Type
Other
Arm Description
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 Type
Device
Intervention Name(s)
Skin Prick Automated Test
Intervention Description
skin prick test to detection sensitisation to aeroallergens
Intervention Type
Diagnostic Test
Intervention Name(s)
Skin Prick Manual Test
Intervention Description
skin prick test to detection sensitisation to aeroallergens
Primary Outcome Measure Information:
Title
Within-test agreement (% of patients with consistent results) of wheal positivity per allergen between manual and automated test.
Description
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.
Time Frame
15 minutes after the diagnostic test
Secondary Outcome Measure Information:
Title
Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.
Description
Visual analogue scale (0: best - 10: worse)
Time Frame
day of the diagnostic test
Title
Time (seconds) required to run an automated versus a manual skin prick test.
Time Frame
during the diagnostic test
Title
Amount of allergen solution that is required to run an automated versus a manual skin prick test.
Time Frame
during the diagnostic test
Title
Level of discomfort experienced by the patient as assessed by visual analogue scale after an automated versus a manual skin prick test.
Description
Visual analogue scale (0: best - 10: worse)
Time Frame
15 minutes after the diagnostic test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik Sebrechts, MD
Organizational Affiliation
AZ Herentals
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Herentals
City
Herentals
ZIP/Postal Code
2200
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Validation and Reproducibility of S.P.A.T. With Allergens
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