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

This study has been completed.
Information provided by:
Mekos Laboratories AS Identifier:
First received: August 22, 2005
Last updated: February 24, 2006
Last verified: February 2006
It is the purpose of this study to determine the concentration of 3 allergens (goldnatriumthiosulphate, methyldibromoglutharonitrile [MDBGN], parthenolide) for diagnosing allergic contact dermatitis.

Condition Intervention Phase
Allergic Contact Dermatitis
Drug: Goldnatriomthiosulphate, MDBGN, parthenolide
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate for ”TRUE Test® Panel 3” – a Phase II, Dose-Response Study.

Resource links provided by NLM:

Further study details as provided by Mekos Laboratories AS:

Primary Outcome Measures:
  • Skin reaction from the 3 patch tests. (Allergic or irritant reaction, grade)

Secondary Outcome Measures:
  • Vehicle (polyvinylpyrrolidone [PVP] or hydroxypropylcellulose [HPC])

Estimated Enrollment: 60
Study Start Date: April 2005
Estimated Study Completion Date: December 2005
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.
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Please refer to this study by its identifier: NCT00133341

Odense University Hospital
Odense, Odense C, Denmark, 5000
Sponsors and Collaborators
Mekos Laboratories AS
Principal Investigator: Klaus E Andersen, Prof. Odense University Hospital
  More Information

Additional Information: Identifier: NCT00133341     History of Changes
Other Study ID Numbers: MEKOS 05 P379/1
Study First Received: August 22, 2005
Last Updated: February 24, 2006

Keywords provided by Mekos Laboratories AS:
Allergic contact dermatitis,patch testing, dilution series

Additional relevant MeSH terms:
Dermatitis, Allergic Contact
Dermatitis, Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents processed this record on May 24, 2017