House Dust Mite AllergySPATprovocatioNCT06803953
Evaluation of an Adjusted Cutoff Value for S.P.A.T (Skin Prick Automated Test) Device in Allergic Subjects
A study testing Skin Prick Automated Test, Skin Prick Manual Test and Nasal Allergen Challenge in people with House Dust Mite Allergy and Birch Pollen Allergy, run by Hippocreates at 1 site in France.
Trial summary
Skin prick test (SPT) is a first line diagnostic test to detect type I hypersensitivity in patients suspected of an inhalant allergy. A novel S.P.A.T. or Skin Prick Automated Test device has been developed to enable more standardised allergy testing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- House Dust Mite Allergy, Birch Pollen Allergy
- What is being tested?
- Skin Prick Automated Test, Skin Prick Manual Test and Nasal Allergen Challenge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2024to 21 Oct 2024
- 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
- Provide informed consent signed by study patient and investigator;
- Subjects with Health Social Identification Number;
- Allergic subjects with rhinitis with or without asthma and with or without conjunctivitis symptoms with proof of sensitisation to an inhalant allergy, either house dust mite ( Dermatophagoides pteronyssinus) or birch pollen by a positive skin prick test (SPT) with a wheal diameter ≥3 mm as compared to negative control. The clinical response against the culprit allergen will be assessed by a positive nasal allergen provocation test. (patients must not have clinical symptoms corresponding to both sensitization).
- Non-allergic subjects with proof of lack of sensitisation to any of the above referred allergens by a negative conventional skin prick test less than 2 years.
- Normal lung function as judged by investigator with FEV 1 and FEV 1/FVC ≥ 70% of predicted
- Willing and able to comply with clinic visits and study-related procedures;
- Able to understand and complete study-related questionnaires.
Who cannot join
- Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment;
- Any skin abnormalities, which could negatively - in the opinion of the investigator - affect the test results, including large scars and tattoos on the forearm ;
- Patients with clinical symptoms corresponding to both sensitization to birch and house dust mite
- 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 (on the forearm) or systemic corticoids < 7 days before the start of the study;
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- Use of any monoclonal antibodies such as omalizumab, dupilumab, mepolizumab < 6 months before the start of the study;
- Use of oral systemic corticosteroids within 4 weeks prior to screening
- Use of intramuscular systemic corticosteroids within 3 months prior to screening
- Use of allergen immunotherapy for the allergen tested (<2 y) or another inhalant allergen;
- Pregnancy or breastfeeding;
- Women without highly effective contraception (hormonal contraception, intrauterine device, bilateral tubal occlusion/ligation, vasectomized partner, sexual abstinence) at least one month prior to inclusion and during the study;
- Incapacitated subjects;
- Subjects who do not speak the local language (French);
- Subjects who cannot read or write.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Definition of a Cut Off Value for S.P.A.T (Skin Prick Automated Test) Device Corresponding With Sensitisation to Both Birch and House Dust Mite Allergens, in Allergic Subjects
Skin prick test (SPT) is a first line diagnostic test to detect type I hypersensitivity in patients suspected of an inhalant allergy. A novel S.P.A.T. or Skin Prick Automated Test device has been developed to enable more standardised allergy testing. In two independent studies, Gorris and colleagues previously showed that test results after S.P.A.T. are less variable and more consistent compared to conventional skin prick testing (Gorris et al. Allergy. 2023; Seys et al. Rhinology 2024). In these studies conducted in volunteers, a cutoff value of 4.5 mm has been proposed based on the 97.5 percentile level of glycerol control wheals.
The current study aims to determine a cutoff value corresponding to the highest accuracy to discriminate between sensitized-allergic and non sensitized, non allergic subjects for both house dust mite and birch allergens.
- Conditions
- House Dust Mite Allergy, Birch Pollen Allergy
- Being tested
- Skin Prick Automated Test, Skin Prick Manual Test, Nasal Allergen Challenge
- Medical subject headings
- Dust Mite Allergy
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
Nasal Allergen ChallengeDiagnostic test
nasal allergen challenge with either house dust mite allergens or birch pollen allergens
| Study group | Role | What they receive |
|---|---|---|
| HDM allergic patients | Experimental | HDM allergic patients receive a nasal allergen provocation test with house dust mite allergens (der p and der f) to confirm the clinical relevance of the allergy.
All patients receive a conventional skin prick test on the one arm and an automated test on the other arm. Receives: Device: Skin Prick Automated Test; Diagnostic Test: Skin Prick Manual Test; Diagnostic Test: Nasal Allergen Challenge |
| Birch pollen allergic patients | Experimental | Birch pollen allergic patients receive a nasal allergen provocation test with birch allergen (bet v) to confirm the clinical relevance of the allergy.
All patients receive a conventional skin prick test on the one arm and an automated test on the other arm. Receives: Device: Skin Prick Automated Test; Diagnostic Test: Skin Prick Manual Test; Diagnostic Test: Nasal Allergen Challenge |
| Non allergic patients | Experimental | Non allergic patients did not receive a nasal allergen provocation test. All patients receive a conventional skin prick test on the one arm and an automated test on the other 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.
Cutoff value with highest accuracy based on longest wheal diameter after SPAT
The cutoff value that corresponds to the highest F1 score of the accuracy of S.P.A.T. to detect sensitisation to both house dust mite and birch allergens by measuring the longest diameter of wheal size.
Measured: 15 minutes after SPAT
Secondary outcomes (1)
Accuracy of SPAT compared to conventional SPT
The non-inferiority of the accuracy of S.P.A.T. compared to the conventional SPT to detect sensitisation for both house dust mite and birch allergens in allergic and non-allergic subjects will be evaluated by comparing the F1 score of SPT and SPAT, measuring the longest diameter of wheal size.
Measured: 15 minutes after SPAT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start17 Sep 2024
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for House Dust Mite AllergyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hippocreates
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Alyatec
- Responsible party
- Sponsor
- Investigators
- Alina Gherasim, MD, Principal investigator, Alyatec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803953
- Sponsor's protocol ID
- HIP-001
- Acronym
- SPATprovocatio
- Status last verified
- Jan 2025
- First submitted
- 3 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Definition of a Cut Off Value for S.P.A.T (Skin Prick Automated Test) Device Corresponding With Sensitisation to Both Birch and House Dust Mite Allergens, in Allergic Subjects
- ClinicalTrials.gov ID
- NCT06803953
- Acronym / sponsor ID
- SPATprovocatio / HIP-001
- Conditions
- House Dust Mite Allergy, Birch Pollen Allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- HippocreatesIndustry (pharma, biotech, devices)
- Collaborators
- Alyatec
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 31 Jan 2025 (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.
Skin prick test (SPT) is a first line diagnostic test to detect type I hypersensitivity in patients suspected of an inhalant allergy. A novel S.P.A.T. or Skin Prick Automated Test device has been developed to enable more standardised allergy testing. In two independent studies, Gorris and colleagues previously showed that test results after S.P.A.T. are less variable and more consistent compared to conventional skin prick testing (Gorris et al. Allergy. 2023; Seys et al. Rhinology 2024). In these studies conducted in volunteers, a cutoff value of 4.5 mm has been proposed based on the 97.5 percentile level of glycerol control wheals.
The current study aims to determine a cutoff value corresponding to the highest accuracy to discriminate between sensitized-allergic and non sensitized, non allergic subjects for both house dust mite and birch allergens.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HDM allergic patients | Experimental | Device: Skin Prick Automated Test, Diagnostic Test: Skin Prick Manual Test, Diagnostic Test: Nasal Allergen ChallengeHDM allergic patients receive a nasal allergen provocation test with house dust mite allergens (der p and der f) to confirm the clinical relevance of the allergy. All patients receive a conventional skin prick test on the one arm and an automated test on the other arm. |
| Birch pollen allergic patients | Experimental | Device: Skin Prick Automated Test, Diagnostic Test: Skin Prick Manual Test, Diagnostic Test: Nasal Allergen ChallengeBirch pollen allergic patients receive a nasal allergen provocation test with birch allergen (bet v) to confirm the clinical relevance of the allergy. All patients receive a conventional skin prick test on the one arm and an automated test on the other arm. |
| Non allergic patients | Experimental | Device: Skin Prick Automated Test, Diagnostic Test: Skin Prick Manual TestNon allergic patients did not receive a nasal allergen provocation test. All patients receive a conventional skin prick test on the one arm and an automated test on the other arm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide informed consent signed by study patient and investigator;
- Subjects with Health Social Identification Number;
- Allergic subjects with rhinitis with or without asthma and with or without conjunctivitis symptoms with proof of sensitisation to an inhalant allergy, either house dust mite ( Dermatophagoides pteronyssinus) or birch pollen by a positive skin prick test (SPT) with a wheal diameter ≥3 mm as compared to negative control. The clinical response against the culprit allergen will be assessed by a positive nasal allergen provocation test. (patients must not have clinical symptoms corresponding to both sensitization).
- Non-allergic subjects with proof of lack of sensitisation to any of the above referred allergens by a negative conventional skin prick test less than 2 years.
- Normal lung function as judged by investigator with FEV 1 and FEV 1/FVC ≥ 70% of predicted
Key exclusion criteria (15 listed)
- Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment;
- Any skin abnormalities, which could negatively - in the opinion of the investigator - affect the test results, including large scars and tattoos on the forearm ;
- Patients with clinical symptoms corresponding to both sensitization to birch and house dust mite
- 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;
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 | Birch pollen allergic patients, HDM allergic patients, Non allergic patients |
| Skin Prick Manual Testskin prick test to detection sensitisation to aeroallergens | Diagnostic test | Birch pollen allergic patients, HDM allergic patients, Non allergic patients |
| Nasal Allergen Challengenasal allergen challenge with either house dust mite allergens or birch pollen allergens | Diagnostic test | Birch pollen allergic patients, HDM allergic patients |
Primary outcome
Cutoff value with highest accuracy based on longest wheal diameter after SPAT
Time frame: 15 minutes after SPAT
The cutoff value that corresponds to the highest F1 score of the accuracy of S.P.A.T. to detect sensitisation to both house dust mite and birch allergens by measuring the longest diameter of wheal size.
1 secondary outcome
Accuracy of SPAT compared to conventional SPT
Time frame: 15 minutes after SPAT
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 31 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Alina Gherasim, MD principal investigator
Alyatec
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, Skin Prick Manual Test and Nasal Allergen Challenge in people with House Dust Mite Allergy and Birch Pollen Allergy, run by Hippocreates at 1 site in France.
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 7 inclusion and 15 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 31 Jan 2025. 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 France. 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?
Cutoff value with highest accuracy based on longest wheal diameter after SPAT (time frame: 15 minutes after SPAT). 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 31 Jan 2025; AzTrials last refreshed its copy on 26 Oct 2026.