Allergy to House DustNCT05824637
Validation and Reproducibility of S.P.A.T. With Allergens
A study testing Skin Prick Automated Test and Skin Prick Manual Test in people with Allergy to House Dust and Allergy Pollen, run by Hippocreates at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergy to House Dust, Allergy Pollen
- What is being tested?
- Skin Prick Automated Test and Skin Prick Manual Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Mar 2023to 30 Jun 2023
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (18-65y) with presence or absence of self-reported symptoms of inhalant allergy will be included.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Allergy to House Dust, Allergy Pollen
- Being tested
- Skin Prick Automated Test, Skin Prick Manual Test
- Medical subject headings
- Rhinitis, Allergic, Seasonal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Prick Automated TestDevice
skin prick test to detection sensitisation to aeroallergens
Skin Prick Manual TestDiagnostic test
skin prick test to detection sensitisation to aeroallergens
| Study group | Role | What they receive |
|---|---|---|
| Skin Prick Test | Other | 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. Receives: Device: Skin Prick Automated Test; Diagnostic Test: Skin Prick Manual Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 minutes after the diagnostic test
Secondary outcomes (4)
Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.
Visual analogue scale (0: best - 10: worse)
Measured: day of the diagnostic test
Time (seconds) required to run an automated versus a manual skin prick test.
Measured: during the diagnostic test
Amount of allergen solution that is required to run an automated versus a manual skin prick test.
Measured: 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.
Visual analogue scale (0: best - 10: worse)
Measured: 15 minutes after the diagnostic test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start18 Mar 2023
- Primary completion30 Apr 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergy to House DustStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocreates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hendrik Sebrechts, MD, Principal investigator, AZ Herentals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824637
- Sponsor's protocol ID
- 1794559
- Status last verified
- Jul 2023
- First submitted
- 30 Jan 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No