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

NCT01628484 | Completed Phase 1

• 1 other identifier: SkinPrep
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Wheal size of the immediate reaction in mm2.

  15 minutes

Secondary Outcomes (1)

• Late phase response.

  3 days

Study Arms (1)

Skin Preparation Testing

OTHER

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; Other: Tape stripping; Other: Microneedle

Interventions

prick lancet OTHER

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.

Also known as: Prick Lancet; Worcestershire, UK; distr. by Stallergenes®.

Skin Preparation Testing

Tape stripping OTHER

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

Also known as: Tesafilm

Skin Preparation Testing

Microneedle OTHER

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.

Also known as: solid Microstructured Transdermal System (sMTS) by 3M®

Skin Preparation Testing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Interventions

PittCoVacc

Study Officials

• Thomas Kuendig, MD

  University Hospital Zurich, Division of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2012
• First Posted: June 26, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

CH (1)