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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Mekos Laboratories AS

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

Original Primary Outcome: Same as current

Current Secondary Outcome: Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])

Original Secondary Outcome: Vehicle (PVP or HPC)

Information By: Mekos Laboratories AS

Dates:
Date Received: August 22, 2005
Date Started: April 2005
Date Completion: December 2005
Last Updated: February 24, 2006
Last Verified: February 2006