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Tracking Information | |||||||||||||||||||||||||
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First Received Date † | March 3, 2008 | ||||||||||||||||||||||||
Last Updated Date | November 20, 2008 | ||||||||||||||||||||||||
Start Date † | April 2008 | ||||||||||||||||||||||||
Current Primary Outcome Measures † |
The performance of each allergen will be evaluated based on: Calculating concordance/discordance between T.R.U.E. Test Panel 3.2 allergens and their corresponding petrolatum or aqueous-based allergens and calculated sensitivity and specificity. [ Time Frame: End of Study ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
Original Primary Outcome Measures † | Same as current | ||||||||||||||||||||||||
Change History | Complete list of historical versions of study NCT00640614 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||
Current Secondary Outcome Measures † |
Evaluations will be based on: Frequency and characterization of late and/or persistent reactions, tape-induced irritation, incomplete panel adhesion, and subject-reported sensations of itching or burning and the frequency of adverse events. [ Time Frame: End of study ] [ Designated as safety issue: No ] | ||||||||||||||||||||||||
Original Secondary Outcome Measures † | Same as current | ||||||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||||||
Brief Title † | Clinical Evaluation of T.R.U.E. TEST® : Safety and Efficacy | ||||||||||||||||||||||||
Official Title † | Clinical Evaluation of T.R.U.E. TEST® Panel 3.2 Allergens: Gold Sodium Thiosulfate, Hydrocortisone-17-Butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse Blue 106, and Bronopol | ||||||||||||||||||||||||
Brief Summary | We propose an open, prospective, multi-center Phase III study to evaluate the diagnostic performance and safety of seven new T.R.U.E. Test allergens: Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Bacitracin, Parthenolide, Methyldibromoglutaronitrile, Disperse blue 106, and Bronopol.Allergen performance and safety will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. |
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Detailed Description | Primary endpoint: The performance (efficacy) of each allergen will be evaluated in adult patients with suspected contact dermatitis, and in adult patients with a known or suspected sensitization to at least one of the seven allergens. Performance will be based on:
Secondary endpoint: To evaluate the safety of seven T.R.U.E. Test Panels 3.2 allergens (Gold sodium thiosulfate, Hydrocortisone-17-butyrate, Methyldibromoglutaronitrile, Bacitracin, Parthenolide, Disperse blue 106 and Bronopol) in adult subjects with suspected contact dermatitis ("consecutives"), and/or in adult subjects with a clinical history of contact dermatitis and a current or previous positive patch test to one (or more) of these 7 allergens ("sensitives"). Evaluations will be based on:
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Study Phase | Phase III | ||||||||||||||||||||||||
Study Type † | Interventional | ||||||||||||||||||||||||
Study Design † | Diagnostic, Open Label, Single Group Assignment, Safety/Efficacy Study | ||||||||||||||||||||||||
Condition † | Contact Dermatitis | ||||||||||||||||||||||||
Intervention † | Biological: T.R.U.E. TEST® Skin Patch Test: Dose Response Allergens | ||||||||||||||||||||||||
Study Arms / Comparison Groups |
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Publications * | |||||||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||||||||||||||
Recruitment Status † | Recruiting | ||||||||||||||||||||||||
Enrollment † | 205 | ||||||||||||||||||||||||
Estimated Completion Date | October 2009 | ||||||||||||||||||||||||
Estimated Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||||||||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||||||||||||||
Ages | 18 Years and older | ||||||||||||||||||||||||
Accepts Healthy Volunteers | Yes | ||||||||||||||||||||||||
Contacts †† |
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Location Countries † | United States, Canada, Denmark | ||||||||||||||||||||||||
Expanded Access Status | |||||||||||||||||||||||||
Administrative Information | |||||||||||||||||||||||||
NCT ID † | NCT00640614 | ||||||||||||||||||||||||
Responsible Party | Kim M. Sullivan/ Study Coordinator, Allerderm | ||||||||||||||||||||||||
Secondary IDs †† | BB-IND#: 13546, Eudra CT#: 2008-000168-18, WIRB Pr. No.: 20080089 | ||||||||||||||||||||||||
Study Sponsor † | Allerderm | ||||||||||||||||||||||||
Collaborators †† | |||||||||||||||||||||||||
Investigators † |
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Information Provided By | Allerderm | ||||||||||||||||||||||||
Verification Date | November 2008 | ||||||||||||||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |