NCT03820154

Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest

A Bridging Study Investigating the Diagnostic Equivalence of the SPT Tape in Comparison With the Conventional SPT Using ALK SoluprickR Allergen Extracts in Patients With Inhalation Allergy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Prof. Dr. Claus Bachert BVBA · Individual
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Testing of a new ready-to-use Tape in comparison to the currently used skin prick test for the diagnosis of allergies. Assessment of clinical equivalence of the SPT Tape for representative common inhalant allergens to conventional SPT in terms of wheal reaction positivity and overall safety. Tests are performed in patients who have a medical history of relevant allergic rhinitis to any of the tested allergens.

Detailed description

An open-label, single site bridging study. Subjects with a history of in-halation allergies will be tested in parallel with the SPT Tape and with the conventional SPT procedure using one forearm each. In each patient, a panel of 8 allergens with the SPT Tape and with the conventional SPT is applied on the two forearms one time only. The following Soluprick® allergens and control solutions will be evaluated: Positive control, negative control, Phleum pratense, birch, Dermatophagoides pteronyssinus, D. farinae, dog dander, cat dander, mugwort, Alternaria sp. The allergens used for the SPT and the SPT Tape are identical Soluprick allergen solutions; allergens will be applied in the same location and order on both arms.

Conditions

• Allergic Rhinitis
• Allergic Asthma
• Allergic Conjunctivitis
• Food Allergy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Skin Prick Test	Skin Prick Testing with inhalant allergens
DIAGNOSTIC_TEST	Skin Prick Test TAPE	Skin Prick Testing with a Tape, integrating the allergens and needles

Timeline

• Start date: 2019-03-01
• Primary completion: 2019-03-31
• Completion: 2019-07-30
• First posted: 2019-01-29
• Last updated: 2019-01-29