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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03820154
Recruitment Status : Not yet recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Claus Bachert BVBA

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.

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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

Information from the National Library of Medicine

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


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

Sponsors and Collaborators
Prof. Dr. Claus Bachert BVBA
Investigators
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Principal Investigator: Martin Wagenmann, MD University pf Düsseldorf, Germany
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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