Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate - Full Text View

Sponsored by:	Mekos Laboratories AS
Information provided by:	Mekos Laboratories AS
ClinicalTrials.gov Identifier:	NCT00133341

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 II

U.S. FDA Resources

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

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

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

Locations

Denmark, Odense C
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

Sponsor's homepage This link exits the ClinicalTrials.gov site

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

Keywords provided by Mekos Laboratories AS:

Allergic contact dermatitis,patch testing, dilution series

Study placed in the following topic categories:

Hypersensitivity
Hypersensitivity, Delayed
Parthenolide
Skin Diseases

Dermatitis, Allergic Contact
Skin Diseases, Eczematous
Dermatitis, Contact
Dermatitis

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs

Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009