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

Allergic Rhinitis Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03820154
• Other study ID #: CBauchert
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 30, 2019

Study information

• Verified date: January 2019
• Source: Prof. Dr. Claus Bachert BVBA
• Contact: Claus U Bachert, MD
• Phone: +32473310902
• Email: claus.bachert[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 75
• Est. completion date: July 30, 2019
• Est. primary completion date: March 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ß-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

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Conjunctivitis
• Allergic Rhinitis
• Conjunctivitis
• Conjunctivitis, Allergic
• Food Allergy
• Food Hypersensitivity
• Hypersensitivity
• Rhinitis
• Rhinitis, Allergic

Intervention

Diagnostic Test:
• Skin Prick Test
Skin Prick Testing with inhalant allergens
• Skin Prick Test TAPE
Skin Prick Testing with a Tape, integrating the allergens and needles

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dr. Claus Bachert BVBA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wheal diameters	Maximal wheal diameter in millimeter	15 min
Secondary	Visual Analogue Scale on Comfort	Visual Analogue Scale from 0-10 cm from "not at all unpleasant" to "very unpleasant"	30 min
Secondary	Patient' s preference	Patients are asked to select the test they would prefer	30 min