Skip to main content
OpenTrials
Completed

NCT Number: NCT00133341

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Contact Dermatitis Dermatitis Dermatitis, Allergic Contact Dermatitis, Contact Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Odense University Hospital

Odense, Odense C, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Goldnatriomthiosulphate, MDBGN, parthenolide

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Mekos Laboratories AS

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Study completion
2005
First posted
Aug 23, 2005
Registry last updated
Feb 27, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.