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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05824637
- Acronym / sponsor ID
- 1794559
- Conditions
- Allergy to House Dust, Allergy Pollen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- HippocreatesIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Prick Test | Other | Device: Skin Prick Automated Test, Diagnostic Test: Skin Prick Manual TestStudy 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (18-65y) with presence or absence of self-reported symptoms of inhalant allergy will be included.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Prick Automated Testskin prick test to detection sensitisation to aeroallergens | Device | Skin Prick Test |
| Skin Prick Manual Testskin prick test to detection sensitisation to aeroallergens | Diagnostic test | Skin Prick Test |
Primary outcome
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.
4 secondary outcomes
Allergy symptoms assessed by visual analogue scale between patients with a positive versus negative test result.
Time frame: day of the diagnostic test
Time (seconds) required to run an automated versus a manual skin prick test.
Time frame: during the diagnostic test
Amount of allergen solution that is required to run an automated versus a manual skin prick test.
Time frame: 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.
Time frame: 15 minutes after the diagnostic test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hendrik Sebrechts, MD principal investigator
AZ Herentals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.