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

Allergic Contact Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133341
• Other study ID #: MEKOS 05 P379/1
• Status: Completed
• Phase: Phase 2
• First received: August 22, 2005
• Last updated: February 24, 2006
• Start date: April 2005
• Est. completion date: December 2005

Study information

• Verified date: February 2006
• Source: Mekos Laboratories AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergic Contact Dermatitis
• Dermatitis
• Dermatitis, Allergic Contact
• Dermatitis, Contact

Intervention

Drug:
• Goldnatriomthiosulphate, MDBGN, parthenolide

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense	Odense C

Sponsors (1)

Lead Sponsor	Collaborator
Mekos Laboratories AS

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
Secondary	Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])

External Links

•   Sponsor's homepage