NCT00133341

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: Mekos Laboratories AS · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Allergic Contact Dermatitis

Interventions

Type	Name	Description
DRUG	Goldnatriomthiosulphate, MDBGN, parthenolide

Timeline

• Start date: 2005-04-01
• Completion: 2005-12-01
• First posted: 2005-08-23
• Last updated: 2006-02-27

Locations

1 site across 1 country: Denmark