Back to resultsDiagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest (SPTTapeD1)
Primary Purpose
Allergic Rhinitis, Allergic Asthma, Allergic Conjunctivitis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Skin Prick Test
Skin Prick Test TAPE
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Skin Prick Test TAPE
Skin Prick Test
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Wheal diameters
Maximal wheal diameter in millimeter
Secondary Outcome Measures
Visual Analogue Scale on Comfort
Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"
Patient' s preference
Patients are asked to select the test they would prefer
Full Information
NCT ID
NCT03820154
First Posted
September 23, 2018
Last Updated
January 26, 2019
Sponsor
Prof. Dr. Claus Bachert BVBA
1. Study Identification
Unique Protocol Identification Number
NCT03820154
Brief Title
Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest
Acronym
SPTTapeD1
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Anticipated)
Primary Completion Date
March 31, 2019 (Anticipated)
Study Completion Date
July 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prof. Dr. Claus Bachert BVBA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis, Allergic Asthma, Allergic Conjunctivitis, Food Allergy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparison of conventional Skin Prick Test vs. Tape SPT
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Skin Prick Test TAPE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Skin Prick Test
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Skin Prick Test
Intervention Description
Skin Prick Testing with inhalant allergens
Intervention Type
Diagnostic Test
Intervention Name(s)
Skin Prick Test TAPE
Intervention Description
Skin Prick Testing with a Tape, integrating the allergens and needles
Primary Outcome Measure Information:
Title
Wheal diameters
Description
Maximal wheal diameter in millimeter
Time Frame
15 min
Secondary Outcome Measure Information:
Title
Visual Analogue Scale on Comfort
Description
Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"
Time Frame
30 min
Title
Patient' s preference
Description
Patients are asked to select the test they would prefer
Time Frame
30 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claus U Bachert, MD
Phone
+32473310902
Email
claus.bachert@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Wagenmann, MD
Organizational Affiliation
University pf Düsseldorf, Germany
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest
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