Status:
COMPLETED
Comparative Study of Skin Prick Allergy Test Measurements Between Current Manual Procedure and Nexkin DSPT Device
Lead Sponsor:
INNOPRICK SL
Collaborating Sponsors:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Allergy
Eligibility:
All Genders
12+ years
Phase:
NA
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 pro...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2021
Estimated Enrollment :
93 Patients enrolled
Trial Details
Trial ID
NCT05284565
Start Date
May 20 2021
End Date
July 27 2021
Last Update
April 24 2023
Active Locations (1)
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1
Clinica Universidad de Navarra, Universidad de Navarra
Pamplona, Navarre, Spain, 31008