AllergyNCT05284565

Comparative Study of Skin Prick Allergy Test Measurements Between Current Manual Procedure and Nexkin DSPT Device

A study testing Reading of the skin prick allergy test in people with Allergy, run by INNOPRICK SL at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Allergy
What is being tested?: Reading of the skin prick allergy test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 93 participants
Where: 1 siteSpain
Study dates: 20 May 2021to 27 Jul 2021
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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

Patients who are to be tested with a prick number greater than 40.
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.
Patients who have taken an antihistamine within the previous 3 days.
Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
Patients who suffer severe atopic dermatitis affecting the forearms.
Patients with dermographism.
Patients who are to undergo intradermal testing.
Pregnant women or women suspected of pregnancy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

Clinica Universidad de Navarra, Universidad de Navarra
Pamplona, Navarre, 31008

Other trials in Spain

About this study

Official title: Concordance Between the Electromedical Device Nexkin DSPT and the Manual Procedure in the Measurement of Papules in Allergy Skin Testing

Read the 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.

Conditions: Allergy
Being tested: Reading of the skin prick allergy test
Keywords: skin prick test, allergy, skin testing, SPT, 3D imaging, allergy testing, allergy test reading, automatic measurement
Medical subject headings: Hypersensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Reading of the skin prick allergy testDevice
A double reading of the forearm will be performed with the Nexkin DSPT device. Also, two healthcare professionals will perform, consecutively, the manual reading according to their usual practice. Nexkin DSPT device provides a semi-automatic wheal detection, presenting the user an initial set of potential wheals and information about them (as their measure).
Healthcare professional can then discard, add and/or confirm wheals by visual validation, and add/edit wheal information. The device automates the test reading process, digitises the results, and quantifies.

Study groups in NCT05284565
Study group	Role	What they receive
Results of reading	Other	All patients who were prick tested and accepted to participate in the study, were prospectively included in the study in only one arm. All of their tests were read by the device and the manual procedure. Receives: Device: Reading of the skin prick allergy test

What is being measured

The primary outcome is the main question the study is designed to answer.

Agreement in wheal size measures in allergy skin testing between the electro-medical device Nexkin DSPT and the manual measurement procedure
Fifteen minutes after the punctures have been performed, a double reading of the forearm shall be taken with the device. The first reading will be stored for later analysis, and the second reading will be used afterwards. The healthcare professional will then perform the manual reading and generate the manual result sheet as is standard practice.
The health professional visually examines the forearm and compares his observation with the identification presented by the device.
The result of the identifications made by the device as well as the interactions of the healthcare professional on the screen shall be recorded on the device.
Diameter measurements are measured in millimetres (mm) and area measurements are measured in square millimetres (mm2).
Measured: 5 minutes

Secondary outcomes (2)

Test-retest reliability of device reading.
15 minutes after the punctures have been performed, a double reading of the forearm shall be taken with the device. The first reading will be stored for later analysis, and the second reading will be used afterwards. The healthcare professional will then perform the manual reading and generate the manual result sheet as is standard practice.
The health professional visually examines the forearm and compares his observation with the identification presented by the device.
The result of the identifications made by the device as well as the interactions of the healthcare professional on the screen shall be recorded on the device.
Diameter measurements are measured in millimetres (mm) and area measurements are measured in square millimetres (mm2).
Measured: 5 minutes
Variability in measurements of histamine wheals made by different health professionals.
15 minutes after the punctures have been performed, a reading of the forearm will be performed by the device. Then, a first healthcare professional will perform the manual reading and generate the manual result sheet as in standard practice.
Immediately afterwards, the first professional will erase the contours of the wheals on the forearm of the patient. A second healthcare professional will perform the manual reading without knowing the reading performed by the first one, and will generate the manual result sheet as is done in routine practice.
The reading order of each test between the two healthcare professionals is randomised.
Diameter measurements are measured in millimetres (mm) and area measurements are measured in square millimetres (mm2).
Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202127 Jul 2021

First posted17 Mar 2022
Study start20 May 2021
Primary completion27 Jul 2021
Study completion27 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for 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: Not applicable
Intervention model: Single group
Model description: The study will prospectively include patients attending the Allergology Department, after signing an informed consent form and a data protection clause.
Masking: None (open label)
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05284565
Sponsor's protocol ID: NEXKIN01
Status last verified: Apr 2023
First submitted: 25 Feb 2022
Last updated: 24 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 28362597
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.
PubMed 27100940
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.
PubMed 35950712

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Allergy trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Concordance Between the Electromedical Device Nexkin DSPT and the Manual Procedure in the Measurement of Papules in Allergy Skin Testing
ClinicalTrials.gov ID: NCT05284565
Acronym / sponsor ID: NEXKIN01
Conditions: Allergy
Keywords: skin prick test, allergy, skin testing, SPT, 3D imaging, allergy testing, allergy test reading, automatic measurement
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: INNOPRICK SLIndustry (pharma, biotech, devices)
Collaborators: Clinica Universidad de Navarra, Universidad de Navarra
Study start: 20 May 2021 (actual)
Primary completion: 27 Jul 2021 (actual)
Study completion: 27 Jul 2021 (actual)
First posted: 17 Mar 2022 (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.

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: The study will prospectively include patients attending the Allergology Department, after signing an informed consent form and a data protection clause.

Arm	Type	Receives
Results of reading	Other	Device: Reading of the skin prick allergy testAll patients who were prick tested and accepted to participate in the study, were prospectively included in the study in only one arm. All of their tests were read by the device and the manual procedure.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

Patients who are to be tested with a prick number greater than 40.
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.
Patients who have taken an antihistamine within the previous 3 days.
Patients who are being treated with antidepressants or other drugs with an antihistamine effect.
Patients who suffer severe atopic dermatitis affecting the forearms.

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
Reading of the skin prick allergy testA double reading of the forearm will be performed with the Nexkin DSPT device. Also, two healthcare professionals will perform, consecutively, the manual reading according to their usual practice. Nexkin DSPT device provides a semi-automatic wheal detection, presenting the user an initial set of potential wheals and information about them (as their measure). Healthcare professional can then discard, add and/or confirm wheals by visual validation, and add/edit wheal information. The device automates the test reading process, digitises the results, and quantifies.	Device	Results of reading

Primary outcome

Agreement in wheal size measures in allergy skin testing between the electro-medical device Nexkin DSPT and the manual measurement procedure
Time frame: 5 minutes
Fifteen minutes after the punctures have been performed, a double reading of the forearm shall be taken with the device. The first reading will be stored for later analysis, and the second reading will be used afterwards. The healthcare professional will then perform the manual reading and generate the manual result sheet as is standard practice. The health professional visually examines the forearm and compares his observation with the identification presented by the device. The result of the identifications made by the device as well as the interactions of the healthcare professional on the screen shall be recorded on the device. Diameter measurements are measured in millimetres (mm) and area measurements are measured in square millimetres (mm2).

2 secondary outcomes

Test-retest reliability of device reading.
Time frame: 5 minutes
Variability in measurements of histamine wheals made by different health professionals.
Time frame: 5 minutes

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 24 Apr 2023.
Background: PubMed 28362597Justo 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.
Background: PubMed 27100940Justo 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.
Background: PubMed 35950712Morales-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.
Individual participant dataSharing planned: No

Related trials for Allergy

RecruitingObservational study
Maximum Lysis on Thromboelastography as a Marker of Systemic Severity in Acute Allergic Reactions
Allergy, Allergic Reactions
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
RecruitingPhase 4
Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food Allergy
Food Allergy
Not yet recruiting
Performance of the Basophil Activation Test in the Diagnosis of IgE-mediated Cow's Milk Allergy in Infants and Evaluation of Hydrolysate Allergenicity.
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Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
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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.

Gabriel Gastaminza Lasarte, Dr. principal investigator

Clinica Universidad de Navarra, Universidad de Navarra

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Reading of the skin prick allergy test in people with Allergy, run by INNOPRICK SL at 1 site in Spain.

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 5 inclusion and 8 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 24 Apr 2023. 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 Spain. 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?

Agreement in wheal size measures in allergy skin testing between the electro-medical device Nexkin DSPT and the manual measurement procedure (time frame: 5 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05284565, which also lists 3 linked publications.

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 24 Apr 2023; AzTrials last refreshed its copy on 1 Nov 2026.