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

Summary

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.

Conditions

• Birch Pollen Allergy

Interventions

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

Tape stripping

For the tape stripping in the skin preparation test conventional self adhesive tape by Tesafilm® is used.

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.

Sponsors & Collaborators

• University of Zurich

  lead OTHER

Principal Investigators

• Thomas Kuendig, MD · University Hospital Zurich, Division of Dermatology

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2012-09-30

Completion

2012-09-30

Countries

• Switzerland

Study Locations