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

• ClinicalTrials.gov Identifier: NCT03820154
• Recruitment Status: Not yet recruiting
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Sponsor: Prof. Dr. Claus Bachert BVBA
• Information provided by (Responsible Party): Prof. Dr. Claus Bachert BVBA

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Allergic Rhinitis; Allergic Asthma; Allergic Conjunctivitis; Food Allergy	Diagnostic Test: Skin Prick Test; Diagnostic Test: Skin Prick Test TAPE	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Comparison of conventional Skin Prick Test vs. Tape SPT
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 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
• Estimated Study Start Date: March 1, 2019
• Estimated Primary Completion Date: March 31, 2019
• Estimated Study Completion Date: July 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Wheal diameters [ Time Frame: 15 min ]
   Maximal wheal diameter in millimeter

Secondary Outcome Measures :

1. Visual Analogue Scale on Comfort [ Time Frame: 30 min ]
   Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"
2. Patient' s preference [ Time Frame: 30 min ]
   Patients are asked to select the test they would prefer

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Claus U Bachert, MD; +32473310902; claus.bachert@ugent.be

Sponsors and Collaborators

Prof. Dr. Claus Bachert BVBA

Investigators

• Principal Investigator: Martin Wagenmann, MD; University pf Düsseldorf, Germany

More Information

• Responsible Party: Prof. Dr. Claus Bachert BVBA
• ClinicalTrials.gov Identifier: NCT03820154
• Other Study ID Numbers: CBauchert
• First Posted: January 29, 2019
• Last Update Posted: January 29, 2019
• Last Verified: January 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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