Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate

February 24, 2006 updated by: Mekos Laboratories AS

Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate for "TRUE Test® Panel 3" - a Phase II, Dose-Response Study.

It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The TRUE Test standard panel consists of two tape strips, panel 1 with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. TRUE test panel 1 and 2 contain 23 of the most frequent contact allergens.With these 23 allergens, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in TRUE Test in order to detect more contact allergic reactions. Therefore goldnatriumthiosulphate, methyldibromoglutharonitrile and parthenolide are developed for inclusion in a third TRUE Test panel. This study is a dose-response study using 3 dilution series to detect the optimum concentration of the 3 allergens. A phase-III study will be performed afterwards to establish the efficacy and safety of the three allergens.

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Odense C
      • Odense, Odense C, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive MDBGN patch test within the latest 5 years or positive Parthenolide patch test within the latest 5 years or positive Goldnatriumthiosulphate patch test within the latest 5 years.
  • Age more or equal to 18 years.
  • Signed informed consent.

Exclusion Criteria:

  • Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
  • Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
  • Treatment with UV-light during the latest 3 weeks.
  • Widespread active dermatitis or dermatitis on test area.
  • Breast-feeding, pregnancy or insufficient contraception. If any doubt a negative urine-pregnancy test should be demonstrated or the patch test should be postponed one period.
  • Subjects not able to cooperate.
  • Participation in other clinical studies during the study period and 3 weeks prior to study start.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)

Secondary Outcome Measures

Outcome Measure
Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mekos Laboratories AS

Investigators

  • Principal Investigator: Klaus E Andersen, Prof., Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Study Completion

December 1, 2005

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (Estimate)

August 23, 2005

Study Record Updates

Last Update Posted (Estimate)

February 27, 2006

Last Update Submitted That Met QC Criteria

February 24, 2006

Last Verified

February 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEKOS 05 P379/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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