Clinical trial NCT05284565: Comparative Study of Skin Prick Allergy Test Measurements Between Current Manual Procedure and Nexkin DSPT Device
Official title: Concordance Between the Electromedical Device Nexkin DSPT and the Manual Procedure in the Measurement of Papules in Allergy Skin Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergy
Keywords: skin prick test
allergy
skin testing
SPT
3D imaging
allergy testing
allergy test reading
automatic measurement
Lead sponsor: INNOPRICK SL
Sponsor class: INDUSTRY
Collaborators: name: Clinica Universidad de Navarra, Universidad de Navarra
First posted: 2022-03-17
Enrollment: 93
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will prospectively include patients attending the Allergology Department, after signing an informed consent form and a data protection clause.
Primary purpose: DIAGNOSTIC

Brief summary: Clinical trial with the aim to evaluate the level of agreement in wheal size measures in allergy skin prick testing (SPT) between the electro-medical device Nexkin DSPT® and the manual measurement procedure used in the daily practice.

Detailed description: The purpose of the trial is to evaluate the concordance of measurements obtained by the Nexkin DSPT device versus the measurements obtained manually.

A prospective clinical trial study was conducted at Clínica Universidad de Navarra. SPT will be tested in the same way as during a routine visit, with the only difference being that the images of the arm required for the device to operate will be captured. Nexkin DSPT device is a non-invasive device, which does not perform the procedure of puncture and appearance of papules. The device is only used to read the test results. There is no risk to the patient or the healthcare professionals involved in capturing images with the device. Device does not provide a diagnosis and it is not a substitute for sound medical judgment.

The study will prospectively include patients attending the allergy consultation (sample size calculated in 93 patients) with positive (histamine) and negative (saline solution) controls. Fifteen minutes later, two consecutive readings with the device and two manual readings were performed by two different nurses. The area of the histamine wheals was measured automatically by Nexkin DSPT and after the manual procedure measured manually by planimetry.

Eligibility criteria: Inclusion Criteria:

1. Patient to be tested with aeroallergen and/or food battery prick tests.
2. Patient over 12 years of age.
3. Patient, or his/her representative, who has given consent to participate in the study.
4. Patient who has not taken an antihistamine for more than 3 days.
5. Women of childbearing age who, at the time of taking the clinical history, declare that they are not pregnant.

Exclusion Criteria:

1. Patients who are to be tested with a prick number greater than 40.
2. Patients who are to be tested with a prick number less than 40, but for whom it is necessary to place more than two rows of allergens in at least one of the arms.
3. Patients who have taken an antihistamine within the previous 3 days.
4. Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
5. Patients who suffer severe atopic dermatitis affecting the forearms.
6. Patients with dermographism.
7. Patients who are to undergo intradermal testing.
8. Pregnant women or women suspected of pregnancy.

Primary outcomes:
measure: Agreement in wheal size measures in allergy skin testing between the electro-medical device Nexkin DSPT and the manual measurement procedure
timeFrame: 5 minutes
Secondary outcomes:
measure: Test-retest reliability of device reading.
timeFrame: 5 minutes
measure: Variability in measurements of histamine wheals made by different health professionals.
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra, Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clinica Universidad de Navarra, Universidad de Navarra
name: Gabriel Gastaminza Lasarte, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Justo X, Diaz I, Gil JJ, Gastaminza G. Medical Device for Automated Prick Test Reading. IEEE J Biomed Health Inform. 2018 May;22(3):895-903. doi: 10.1109/JBHI.2017.2680840. Epub 2017 Mar 9.
citation: Justo X, Diaz I, Gil JJ, Gastaminza G. Prick test: evolution towards automated reading. Allergy. 2016 Aug;71(8):1095-102. doi: 10.1111/all.12921. Epub 2016 May 20.
citation: Morales-Palacios MP, Nunez-Cordoba JM, Tejero E, Matellanes O, Quan PL, Carvallo A, Sanchez-Fernandez S, Urtasun M, Larrea C, Iniguez MT, Gimenez R, Goikoetxea MJ, D'Amelio CM, Ferrer M, Gastaminza G. Reliability of a novel electro-medical device for wheal size measurement in allergy skin testing: An exploratory clinical trial. Allergy. 2023 Jan;78(1):299-301. doi: 10.1111/all.15474. Epub 2022 Aug 20. No abstract available.