Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest (SPTTapeD1)
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ClinicalTrials.gov Identifier: NCT03820154 |
Recruitment Status : Unknown
Verified January 2019 by Prof. Dr. Claus Bachert BVBA.
Recruitment status was: Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
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Condition or disease | Intervention/treatment | Phase |
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Allergic Rhinitis Allergic Asthma Allergic Conjunctivitis Food Allergy | Diagnostic Test: Skin Prick Test Diagnostic Test: Skin Prick Test TAPE | Not Applicable |
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 (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 |

Arm | Intervention/treatment |
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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.
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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.
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Diagnostic Test: Skin Prick Test
Skin Prick Testing with inhalant allergens |
- Wheal diameters [ Time Frame: 15 min ]Maximal wheal diameter in millimeter
- Visual Analogue Scale on Comfort [ Time Frame: 30 min ]Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"
- Patient' s preference [ Time Frame: 30 min ]Patients are asked to select the test they would prefer

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820154
Contact: Claus U Bachert, MD | +32473310902 | claus.bachert@ugent.be |
Principal Investigator: | Martin Wagenmann, MD | University pf Düsseldorf, Germany |
Responsible Party: | Prof. Dr. Claus Bachert BVBA |
ClinicalTrials.gov Identifier: | NCT03820154 |
Other Study ID Numbers: |
CBauchert |
First Posted: | January 29, 2019 Key Record Dates |
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 |
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 |