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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03820154
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Prof. Dr. Claus Bachert BVBA
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Martin Wagenmann, MD
Principal Investigator Affiliation University pf Düsseldorf, Germany
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Allergic Rhinitis, Allergic Asthma, Allergic Conjunctivitis, Food Allergy
Additional Details

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.

Arms & Interventions

Arms

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.

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.

Interventions

Diagnostic Test: - Skin Prick Test

Skin Prick Testing with inhalant allergens

Diagnostic Test: - Skin Prick Test TAPE

Skin Prick Testing with a Tape, integrating the allergens and needles

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Claus U Bachert, MD

claus.bachert@ugent.be

+32473310902

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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