Comparison of the Influence of Different Skin Conditions on the Allergic Skin Reactivity to Epicutanous Allergen Exposure

NCT02074930 | Completed DMC

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

Brief Summary

It is an open-label physiological investigation of the allergic skin reactivity to epicutaneous allergen exposition in 20 allergic patients in two different skin conditions. The focus of the study is on the skin preparation/condition and not on the specific allergen or allergy, but for reasons of homogeneity a single allergic disease, birch pollen allergy was chosen as the basis for the testing. In order to evaluate the effects of the two different skin preparation techniques an intraindividual comparison of the skin reactivity in terms of the immediate phase I reaction to serial dilutions of birch pollen extracts was chosen. The serial dilution approach allows a dose dependent effect evaluation and comparison of the sensitivity. The differences will be explained mainly by the two different skin preparations allowing a quantitative comparison of these techniques.

Conditions

Birch Pollen Allergy

Outcome Measures

Primary Outcomes (1)

• Wheal Size (mm^2)

  The minimal protein concentration eliciting a wheal size of \>0mm\^2 will be compared between the two different skin preparation techniques with a Wilcoxon signed ranks test.

  The primary outcome will be assesed after 15min after allergen exposure

Secondary Outcomes (1)

• Wheal Size

  Wheal size will be assessed after 15 Minutes

Study Arms (1)

Single Arm

OTHER

Device: Microporation by P.L.E.A.S.E. Professional / Prick needle

Interventions

Microporation by P.L.E.A.S.E. Professional / Prick needle DEVICE

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent,
• years old (male or female),
• a positive clinical history for inhalant allergy presumably due to birch pollen,
• positive screening prick test (mean wheal diameter bigger or equal than 3mm) to birch pollen allergen solution,
• a mean wheal size of bigger or equal than 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,
• enrolment into a clinical trial within last 4 weeks,
• 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,
• known or suspected non-compliance, drug or alcohol abuse

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

University Hospital Zurich, Division of Dermatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

Study Officials

• Thomas Kündig, MD

  University Hospital Zurich, Division of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2014
• First Posted: February 28, 2014
• Study Start: February 1, 2014
• Primary Completion: April 1, 2014
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

CH (1)