Evaluation of High Speed Laser Doppler Imaging Technology

Hay Fever Clinical Trial

— HSL-DI  

Official title:

Evaluation of High Speed Laser Doppler Imaging Technology to Quantify Skin Prick Tests in Allergic Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619331
• Other study ID #: HSL-DI
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: November 28, 2015
• Start date: February 2008
• Est. completion date: September 2011

Study information

• Verified date: November 2015
• Source: Centre Hospitalier Universitaire Vaudois
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Skin prick tests (SPT) are commonly used in daily allergological practice to assess skin reactivity to allergens. Multiple factors can contribute to non-optimal results of conventional wheal and flare measurement (CWFM) of SPT such as inaccurate measurements, observer-dependency and absence of traceability.

This study aims to evaluate the quantification of SPT by a novel High Speed Laser Doppler Imaging (HSL-DI) and to compare it with CWFM. First, SPT with birch and/or grass pollen extracts as well as positive and negative controls will be performed in 20 volunteers (11 atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and allergen concentration) of HSL-DI analysis based on two parameters ("area" and "flow" measurement). In a second step, fifty patients will be tested with birch and grass pollen extracts at optimal allergen concentration and time window. Analysis of SPT by HSL-DI and CWFM will be compared.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18 to 65 years

• history of allergic rhinitis to birch pollen and/or grass pollen.

Exclusion Criteria:

• any medical condition (including pregnancy) that could influence the study (viral or bacterial airway infection, active allergic rhinitis)

• uncontrolled asthma (peak expiratory "flow" <80% of volunteer's best personal value)

• treatment with antihistamine medication less than two weeks before enrolment or during the trial.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hay Fever

Intervention

Procedure:
• Allergy test reading
Reading of allergy skin tests (in response to allergen extracts or histamine or negative control) by HSL-DI versus direct observer evaluation (CWFM)

Locations

Country	Name	City	State
Switzerland	CHUV , Division of Immunology and Allergy	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin microcirculation flow changes over time (composite autcome)	Skin microcirculation flow changes will be evaluated at 2.5 min., 5 min., 7.5 min., 10 min., 12.5 min., 15 min., 17.5 min. and 20 min. as measured in a composite outcome 1) by HS-LDI based on parameter "area" corresponding to the total number of non-zero pixels in the flare area and parameter "flow" as measured according to a specific formula in arbitrary units, or 2) as measured by conventional wheal and flare measurement (CWFM, direct observer reading) in mm.	tests reading at 2.5 min., 5 min., 7.5 min., 10 min., 12.5 min., 15 min., 17.5 min. and 20 min.	No