Evaluation of an Adjusted Cutoff Value for S.P.A.T (Skin Prick Automated Test) Device in Allergic… (NCT06803953) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of an Adjusted Cutoff Value for S.P.A.T (Skin Prick Automated Test) Device in Allergic Subjects
France75 participantsStarted 2024-09-17
Plain-language 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. 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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 da…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cutoff value with highest accuracy based on longest wheal diameter after SPAT