Automated skin test reading of prick tests with the skin test scanner Nexkin DSPT®
Summary description of the study
In this research project, we want to investigate whether skin testing for clarifying, e.g., hay fever can also be evaluated automatically with a device with a high-resolution camera. We want to find out if this device allows for more accurate and faster evaluations than those performed by medical personnel. Prick tests are usually the examination of choice for clarifying respiratory and food allergies in order to prove allergies. Drops of allergy-triggering substances, such as pollen, are applied to the inner side of the forearm. Subsequently, each test site is superficially pierced with a tiny needle (lancet). After 15 minutes, the test can already be read. It is evaluated at which test sites a wheal and redness appear. In the last 20 years, little has changed in the execution. Both the application of the skin test and especially the subsequent evaluation and documentation are performed manually by medical personnel. An automatic reading with direct documentation in the digital clinic system would therefore be a significant simplification. We would like to find out what the advantages of an automated skin test reading device are. To this end, we also want to capture whether more accurate results and a faster evaluation are possible. We will only scan the forearm with the automated skin test reading device using a camera, which means an additional effort of about 3 minutes. No further consultations are necessary for this study.
(BASEC)
Intervention under investigation
The study will be conducted as part of a regular allergy clarification, provided that prick tests are performed. Immediately after the reading of the prick tests by the medical personnel, the forearm will be additionally placed under a device with a camera, which will then automatically re-evaluate the skin test. The reading process takes less than 30 seconds, the switch to the device and positioning the arm requires a maximum additional effort of 3 minutes. No further appointments for the study are planned.
(BASEC)
Disease under investigation
Skin testing for clarifying hay fever/aeroallergies and food allergies
(BASEC)
Routine allergy clarification with the performance of prick tests Minimum age 18 years No intake of antihistamines in the last 5 days (BASEC)
Exclusion criteria
Patients under anti-allergic medications. Patients with skin diseases, especially eczema in the arm area. Patients with more than 40 prick tests. (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Inselspital Bern
(BASEC)
Contact
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
08.08.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Sensitivity and specificity study of electromedical device Nexkin DSPT and manual measurement of hives in allergy skin prick tests (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
not available
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available