Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest (SPTTapeD1)

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

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.

Study Overview

• Status: Unknown
• Conditions: Allergic Rhinitis; Allergic Conjunctivitis; Food Allergy; Allergic Asthma
• Intervention / Treatment: Diagnostic test: Skin Prick Test TAPE; Diagnostic test: Skin Prick Test

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.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects will be included only, if

  1. they were informed about the nature, meaning, and scope of the study, and if they provided written consent to their participation
  2. they are at least 18 years of age,
  3. 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

Exclusion Criteria:

• Subjects may not be included, if

  1. they are impaired in understanding nature, meaning, and the scope of the study, or are incapable of giving written informed consent,

  2. 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:

     1. acute allergy,
     2. history of systemic reactions or hypersensitivity to allergens, abuse of drugs or alcohol
     3. severe diseases,
     4. impaired reactivity of the skin (e.g. hyperkeratosis, ichthyosis, urticaria factitia) and acute chronic eczema in the skin test areas, skin infections,
     5. pregnancy or nursing,
     6. treatment with β-blockers,
     7. treatment with antihistamines or systemic glucocorticoids during the last 4 weeks, with astemizol during the last 12 weeks,
     8. treatment with tricyclic antidepressants benzodiazepines, and neuroleptic drugs which may have histamine-antagonistic effects during the last 2 weeks,
     9. participation in any other medication study at the study time

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Skin Prick Test TAPE; 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 Testing with a Tape, integrating the allergens and needles
Active Comparator: Skin Prick Test; 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; Skin Prick Testing with inhalant allergens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wheal diameters	Maximal wheal diameter in millimeter	15 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale on Comfort	Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"	30 min
Patient' s preference	Patients are asked to select the test they would prefer	30 min

Collaborators and Investigators

• Sponsor: Prof. Dr. Claus Bachert BVBA
• Investigators: Principal Investigator: Martin Wagenmann, MD, University pf Düsseldorf, Germany

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2019
• Primary Completion (Anticipated): March 31, 2019
• Study Completion (Anticipated): July 30, 2019

Study Registration Dates

• First Submitted: September 23, 2018
• First Submitted That Met QC Criteria: January 26, 2019
• First Posted (Actual): January 29, 2019

Study Record Updates

• Last Update Posted (Actual): January 29, 2019
• Last Update Submitted That Met QC Criteria: January 26, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Nose Diseases; Conjunctival Diseases; Hypersensitivity; Rhinitis; Rhinitis, Allergic; Conjunctivitis; Conjunctivitis, Allergic; Food Hypersensitivity
• Other Study ID Numbers: CBauchert

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No