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CompletedNCT00133341Updated Feb 27, 2006

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

A Phase 2 interventional study of Goldnatriomthiosulphate, MDBGN, parthenolide in Allergic Contact Dermatitis, sponsored by Mekos Laboratories AS. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-02-27.

Sponsored by Mekos Laboratories AS · Phase 2, Interventional, and Diagnostic

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Allergic Contact Dermatitis

Keywords

  • Allergic contact dermatitis,patch testing, dilution series
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In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 60 is close to the median of 64 across 1,131 interventional studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Mekos Laboratories AS is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Double
Enrollment
60 participants

Interventions

  • DrugGoldnatriomthiosulphate, MDBGN, parthenolide
06

What researchers measure

Primary outcomes

  1. Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)

Secondary outcomes

  1. Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])

07

Study locations

1 site
  • Odense University Hospital
    Odense, Odense C 5000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00133341
Lead sponsor
Mekos Laboratories AS
First posted
Aug 23, 2005
Start date
Apr 2005
Completion
Dec 2005
Last update
Feb 27, 2006

Study contacts

Klaus E Andersen, Prof.
principal investigator · Odense University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2006. You cannot join it, but the record below documents what was studied.

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