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| Tracking Information | |||||||||
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| First Received Date ICMJE | August 30, 2006 | ||||||||
| Last Updated Date | August 4, 2008 | ||||||||
| Start Date ICMJE | September 2006 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Identification of disease-specific potential diagnostic markers in plasma and PBMC. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00371163 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Molecular and Cellular Characterization of Spongiotic Dermatitis | ||||||||
| Official Title ICMJE | Molecular and Cellular Characterization of Spongiotic Dermatitis | ||||||||
| Brief Summary | Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous dermatitis. The information obtained will assist in development of diagnostic methods for differentiation of the types of spongiotic dermatitis. This study also has the potential to lead to the dissection of pathologic pathways involved in these diseases and development of novel therapeutic agents. |
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| Detailed Description | Spongiotic dermatitis is the histopathologic diagnosis commonly issued by dermatopathologists that encompasses atopic dermatitis, contact dermatitis, and other forms of eczematous dermatitis. Atopic dermatitis is a chronic, relapsing inflammatory disease characterized by pruritic, scaly, red, eczematous skin lesions, and a personal or family history of atopy. Patients affected by atopic dermatitis experience significant morbidity from extreme pruritus, recurrent cutaneous infections, and extensive and/or disfiguring skin lesions. Allergic contact dermatitis typically manifests as pruritus and vesicular or eczematous lesions associated with direct exposure to environmental haptenic allergens. The specific aims of this research are:
The information obtained will assist in development of diagnostic methods for differentiation of the types of spongiotic dermatitis. This study also has the potential to lead to the dissection of pathologic pathways involved in these diseases and development of novel therapeutic agents. |
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| Study Phase | Phase II, Phase III | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Procedure: microarray analyses. | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* 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 ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | December 2008 | ||||||||
| Estimated Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Subjects will be asked to discontinue topical medications at least to parts of the skin where biopsies will be taken, one week prior to biopsy. - Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 55 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00371163 | ||||||||
| Responsible Party | Fu-Tong Liu, University of California Davis | ||||||||
| Study ID Numbers ICMJE | 200614530-1 | ||||||||
| Study Sponsor ICMJE | University of California, Davis | ||||||||
| Collaborators ICMJE | Genentech | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of California, Davis | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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