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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00133341

Enrollment

Registered

2005-08-23

Start date

2005-04-30

Completion date

2005-12-31

Last updated

2006-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Contact Dermatitis

Keywords

Allergic contact dermatitis,patch testing, dilution series

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.

Interventions

DRUGGoldnatriomthiosulphate, MDBGN, parthenolide

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)	—

Secondary

Measure	Time frame
Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])	—

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026