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NCT Number: NCT06743737

Digital Device Reading Skin Prick Test

Skin prick tests (SPTs), or intraepidermal tests, are the first diagnostic approach for people with a suspected allergy. SPTs are very simple, safe and quick. They are cheap tests and are very useful as a screening test for allergy, especially in diseases like bronchial asthma, rhinoconjunctivitis, food/drug allergy and anaphylaxis. Together with the clinical history, SPTs allow to draw conclusions on allergies based on the sensitization pattern.

Nevertheless, the technique itself has evolved very little and continues to be performed entirely manually. This has a few drawbacks that limit the utility of the tests, in many cases limiting them to a purely qualitative assessment.

In comparison to standard practice (manual measurement), the digital skin test reading device Nexkin DSPT can provide the following benefits for project participants: Automates and digitizes the test reading, provides test results in digital format, reduces variability and subjectivity and greater consistency of diagnosis, reduces manual tasks allowing health professionals providing quantitative instead of qualitative results and avoiding potential human errors and allows a faster workflow, resulting in shorter patient visits.

The aim of this study is to validate the clinical utility of the electromedical skin test reading device Nexkin DSPT regarding its use in allergology clinics for the reading of skin prick allergy tests. The overall purpose of the study is to determine the sensitivity and specificity of skin prick tests (SPT) performed using the current practice of the fully manual SPT procedure and those performed using the Nexkin SPT DSPT (digital) procedure and to compare the sensitivity and specificity of both methods.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inselspital, Bern University Hospital, University of Bern

Bern, 3010, Switzerland

Location status: Recruiting

Location contact

Lukas Jörg

CONTACT

[email protected]

+41 31 632 22 69

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who will undergo skin prick tests with panels of aeroallergens and/or foods.

Over 18 years of age. The patient or their representative has given consent to participate in the study.

The patient must not have taken an antihistamine in the last 5 days.

Exclusion criteria

Patients who are evaluated by more than 40 prick tests. Patients who have taken an antihistamine within the previous 5 days. Patients who are being treated with antidepressants or other drugs with an antihistamine effect.

Patients who suffer severe atopic dermatitis with forearm involvement. Patients with dermographism. Patients who are evaluated by intradermal testing. Pregnant women or women suspected to be pregnant. Vulnerable patients

Treatment and study plan

Digital skin test reading device

Device

The device to be studied measures optically the size of the wheals from skin tests (SPT) performed for the diagnosis of allergen sensitization.

Primary outcomes

  1. Measurement of the histamine (positive control) wheal by healthcare professional

    Time frame: At enrollment

  2. Measurement of the NaCl (negative control) wheal by healthcare professional

    Time frame: At enrollment

  3. Measurement of the histamine (positive control) wheal by digital device

    Time frame: At enrollment

  4. Measurement of the NaCl (negative control) wheal by digital device

    Time frame: At enrollment

Secondary outcomes

  1. Measure of the time involved in the complete reading and recording of the results

    Time frame: At enrollment

    Minutes and seconds of procedure (testing & recording of results) will be recorded for both the manual procedure and the procedure using the digital device

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • sitem-insel AG Bern

Registry information

Official study title

Sensitivity and Specificity Study of Electromedical Device Nexkin DSPT and Manual Measurement of Hives in Allergy Skin Prick Tests

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.