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

This study has been completed.
Sponsor:
Information provided by:
Mekos Laboratories AS
ClinicalTrials.gov Identifier:
NCT00133341
First received: August 22, 2005
Last updated: February 24, 2006
Last verified: February 2006
  Purpose

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
Endpoint Classification: Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00133341

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00133341     History of Changes
Other Study ID Numbers: MEKOS 05 P379/1
Study First Received: August 22, 2005
Last Updated: February 24, 2006
Health Authority: Denmark: Danish Medicines Agency
Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Allergic Contact
Dermatitis, Contact
Hypersensitivity
Hypersensitivity, Delayed
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Parthenolide
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014