Status:
UNKNOWN
Diagnostic Equivalence of the Skin Prick Test Tape vs. Conventional Skin PrickTest
Lead Sponsor:
Prof. Dr. Claus Bachert BVBA
Conditions:
Allergic Rhinitis
Allergic Asthma
Eligibility:
All Genders
18-65 years
Phase:
NA
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 inha...
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....
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2019
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03820154
Start Date
March 1 2019
End Date
July 30 2019
Last Update
January 29 2019
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