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

NCT03820154 | Unknown

• 1 other identifier: CBauchert
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Allergic Rhinitis; Allergic Asthma; Allergic Conjunctivitis; Food Allergy

Outcome Measures

Primary Outcomes (1)

• Wheal diameters

  Maximal wheal diameter in millimeter

  15 min

Secondary Outcomes (2)

• Visual Analogue Scale on Comfort

  30 min

• Patient' s preference

  30 min

Study Arms (2)

Skin Prick Test TAPE

ACTIVE COMPARATOR

The Skin Prick Test Tape is an innovative sterile "all-in" drug carrying 8 allergens and 2 control solutions including prick needles in one Tape for easy use and standardization. Single use. Reading of wheal reactions after 15 minutes, facilitated by stripes with the allergen names.

Diagnostic Test: Skin Prick Test TAPE

Skin Prick Test

ACTIVE COMPARATOR

The conventional SPT is the world-wide standard in allergy Type 1 diagnosis for inhalant and food allergens. Drops of allergens are applied to the forearm and, with the help of a lancet, brought into the skin. Reading of wheal reactions after 15 minutes.

Diagnostic Test: Skin Prick Test

Interventions

Skin Prick Test DIAGNOSTIC_TEST

Skin Prick Testing with inhalant allergens

Skin Prick Test

Skin Prick Test TAPE DIAGNOSTIC_TEST

Skin Prick Testing with a Tape, integrating the allergens and needles

Skin Prick Test TAPE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be included only, if
• they were informed about the nature, meaning, and scope of the study, and if they provided written consent to their participation
• they are at least 18 years of age,
• they have a history of allergic rhinitis due to grass and/or birch pollen, house dust mites, mugwort, cat and/or dog dander, and/or Alternaria since 2 years or more

You may not qualify if:

• Subjects may not be included, if
• they are impaired in understanding nature, meaning, and the scope of the study, or are incapable of giving written informed consent,
• they suffer from diseases, show other conditions, or take medications, which might impact the skin tests or might contradict the correct conduct and evaluation of the study. In particular this includes the following:
• acute allergy,
• history of systemic reactions or hypersensitivity to allergens, abuse of drugs or alcohol
• severe diseases,
• impaired reactivity of the skin (e.g. hyperkeratosis, ichthyosis, urticaria factitia) and acute chronic eczema in the skin test areas, skin infections,
• pregnancy or nursing,
• treatment with β-blockers,
• treatment with antihistamines or systemic glucocorticoids during the last 4 weeks, with astemizol during the last 12 weeks,
• treatment with tricyclic antidepressants benzodiazepines, and neuroleptic drugs which may have histamine-antagonistic effects during the last 2 weeks,
• participation in any other medication study at the study time

Sponsors & Collaborators

• Prof. Dr. Claus Bachert BVBA: lead

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis, Allergic; Food Hypersensitivity

Interventions

Patch Tests

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques

Study Officials

• Martin Wagenmann, MD

  University pf Düsseldorf, Germany

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claus U Bachert, MD

CONTACT

+32473310902; claus.bachert@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: Comparison of conventional Skin Prick Test vs. Tape SPT

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: January 29, 2019
• Study Start: March 1, 2019
• Primary Completion: March 31, 2019
• Study Completion: July 30, 2019
• Last Updated: January 29, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share