Physiological Study to Determine the Allergic Skin Activity After Different Skin Preparation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01628484
First received: June 22, 2012
Last updated: November 6, 2012
Last verified: November 2012
  Purpose

The objectives of this monocentric investigator initiated exploratory clinical trial is to optimize allergen delivery across the epidermal barrier. The cornified outer epidermal layers represent the main barrier towards entry into the viable epidermal layers. In the latter we aim to target the allergen for uptake by professional antigen presenting cells, called Langerhans cells. At the same time as little allergen as possible should be delivered to the dermis. The latter contains a high density of sensitized mast cells eliciting local reactions and also a high density of blood vessels which could lead to systemic distribution of allergen and therefore to systemic allergic reactions.

In birch pollen allergic individuals we will compare different methods of preparing the skin before application of the allergen. We will subsequently apply titrated allergen doses to the prepared skin areas to determine at which dose we start observing mast cell degranulation manifesting as hives.

This will allow for determination of the maximal tolerated allergen dose for each skin preparation method.

The skin preparation methods compared will be:

  • Single pricking with prick lancet (Entaco LTD., Redditch, Worcestershire, UK, distributed by Stallergenes®).
  • Tape stripping with conventional adhesive Tape (Tesa-film®).
  • Microchanneling with Micro Needle Patch (Micro Skin System, 3M®). The methods are strongly connected to routine diagnostics of allergies with low risk associated.

The clinical trial protocol has been submitted to the local Ethics Committee.

This comparison of skin preparation methods and the determination of the maximal tolerated allergen dose will help us to further improve epicutaneous allergen immunotherapy, which has the potential to make allergen specific immunotherapy not only considerably shorter and safer, but also more convenient for patients. Skin preparation by microneedle patches is significantly less painful than conventional injection and can be self administered. This should help improve the acceptance of allergen specific immunotherapy, as well as treatment compliance.


Condition Intervention Phase
Birch Pollen Allergy
Other: prick lancet
Other: Tape stripping
Other: Microneedle
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutaneous Allergen Exposure

Resource links provided by NLM:


Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Wheal size of the immediate reaction in mm2. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Late phase response. [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    Evaluation of late phase reaction (eczema development).


Enrollment: 20
Study Start Date: July 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Skin Preparation Testing
The methodology of this study is an intra-individual comparison. Each study participant is treated with three skin preparation techniques (pricking, tape stripping, microneedle array)on both volar forearms.
Other: prick lancet
For the pricking skin preparation, sterile prick lancets for 1mm point skin testing will be used. They are used for allergy diagnostics in daily routine.
Other Name: Prick Lancet; Worcestershire, UK; distr. by Stallergenes®.
Other: Tape stripping
For the tape stripping in the skin preparation test conventional self adhesive tape by Tesafilm® is used.
Other Name: Tesafilm
Other: Microneedle
To induce a large number of microchannels with a maximal depth of 150µm into the cornea layer a small patch of 351 tiny needles is used, which is on the market in the US and is intended for preparing the skin for transdermal application of topical dermatology products.
Other Name: solid Microstructured Transdermal System (sMTS) by 3M®

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Written informed consent
  • 18-65 years old (male and female)
  • A positive clinical history for inhalant allergy presumably due to birch pollen
  • Positive screening prick test (mean wheal diameter = 3mm) to birch pollen allergen solution
  • A mean wheal size of = 7mm2 obtained in the screening prick test with histamine dihydrochloride (10mg/ml)

Exclusion criteria:

  • Impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent
  • Participation in another clinical trial within the last 30 days and during the present study
  • Pregnancy or nursing
  • Positive skin reaction in the screening prick test to NaCl
  • Currently suffering from allergy symptoms
  • History of systemic reactions to allergens
  • Severe diseases influencing the results of the present study by discretion of the investigator
  • Immunotherapy with the allergen preparation during the past two years
  • Skin lesions and excessive hair-growth in the skin test areas
  • Treatment with prohibited concomitant medications, with the exception of medications with local effects which will not influence the results of the skin prick tests
  • Alcohol or drug abuse
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01628484

Locations
Switzerland
University Hospital Zurich, Division of Dermatology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Thomas Kuendig, MD University Hospital Zurich, Division of Dermatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01628484     History of Changes
Other Study ID Numbers: SkinPrep
Study First Received: June 22, 2012
Last Updated: November 6, 2012
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014