Clinical trial NCT00133341: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Contact Dermatitis
Keywords: Allergic contact dermatitis,patch testing, dilution series
Lead sponsor: Mekos Laboratories AS
Sponsor class: INDUSTRY
First posted: 2005-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)
Secondary outcomes:
measure: Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Odense C
Study officials:
affiliation: Odense University Hospital
name: Klaus E Andersen, Prof.
role: PRINCIPAL_INVESTIGATOR
References: