Back to resultsClinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate
Primary Purpose
Allergic Contact Dermatitis
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Goldnatriomthiosulphate, MDBGN, parthenolide
Sponsored by
About this trial
This is an interventional diagnostic trial for Allergic Contact Dermatitis focused on measuring Allergic contact dermatitis,patch testing, dilution series
Eligibility Criteria
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.
Sites / Locations
- Odense University Hospital
Outcomes
Primary Outcome Measures
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
Secondary Outcome Measures
Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])
Full Information
NCT ID
NCT00133341
First Posted
August 22, 2005
Last Updated
February 24, 2006
Sponsor
Mekos Laboratories AS
1. Study Identification
Unique Protocol Identification Number
NCT00133341
Brief Title
Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate
Official Title
Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate for "TRUE Test® Panel 3" - a Phase II, Dose-Response Study.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mekos Laboratories AS
4. Oversight
5. Study Description
Brief Summary
It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Contact Dermatitis
Keywords
Allergic contact dermatitis,patch testing, dilution series
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Goldnatriomthiosulphate, MDBGN, parthenolide
Primary Outcome Measure Information:
Title
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
Secondary Outcome Measure Information:
Title
Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus E Andersen, Prof.
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense
State/Province
Odense C
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://www.mekos.dk
Description
Sponsor's homepage
Learn more about this trial
Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate
We'll reach out to this number within 24 hrs