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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 7, 2007 | ||||||||
| Last Updated Date | September 29, 2009 | ||||||||
| Start Date ICMJE | March 2008 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Treg level and function [ Time Frame: Prospective ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Treg level and function [ Time Frame: Prospective ] | ||||||||
| Change History | Complete list of historical versions of study NCT00555178 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Blood cytokine levels [ Time Frame: prospective ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Blood cytokine levels [ Time Frame: prospective ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Regulatory T Cells (Tregs) in Polymorphic Light Eruption | ||||||||
| Official Title ICMJE | Regulatory T Cells (Tregs) in Polymorphic Light Eruption | ||||||||
| Brief Summary | Polymorphic light eruption (PLE) is a photodermatosis with an extremely high prevalence, particularly among young women (up to 20%). The disease is characterized through itchy skin lesions on sun-exposed body sites occurring after sun exposure mostly in spring and early summer. Its etiopathogenesis is unknown but resistance to UV-induced immunosuppression with subsequent immune reactions against skin photoneoantigens has been suggested. Regulatory T cells (CD4+CD25+FoxP3+) (Tregs), a subset of T helper cells, are crucial for the induction of immunosuppression. We will test the hypothesis that PLE patients show pathogenic fluctuating Treg levels and function over the seasons of the year, possibly being responsible for lack of immune modulation and autoimmunity in PLE. Natural or medical photohardening may normalize Treg deficiency in PLE and lead to clinical adaption in summer. Better insight into the pathogenesis of PLE may give clues to develop new therapeutic strategies. |
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| Detailed Description | PLE patients will be recruited through the Photodermatology Unit of the Department of Dermatology, Medical University of Graz, Graz, Austria. Eligible patients will be identified through diagnosis-related computer-assisted search in the electronic patient chart system of the Unit. The diagnosis of PLE will be verified by patient's history, clinical symptoms, histologic findings, laboratory studies and/or phototesting procedures. The levels and function of Tregs as well as cytokine profiles in the blood will be studied in the PLE patients compared to control groups. Volunteers of four groups will be enrolled in this study: i) patients with PLE undergoing preventive medical UV photohardening in spring; ii) PLE patients not undergoing preventive UV photohardening; iii) healthy control subjects; and iv) patients with other diseases (including psoriasis, atopic dermatitis, and other conditions) undergoing therapeutic phototherapy. Blood will be taken by venous puncture (mainly of a cubital vein) from the individual study participants at four defined time points during the year: (i) spring (March to April) (before medical photohardening in PLE patients); (ii) spring/early summer (April to June) (immediately after medical photohardening of PLE patients); (iii) late summer (August to September); and (iv) late fall (November to December). At these time points, Treg levels and function as well as cytokine mRNA and protein levels in the blood will be determined by FACS, proliferation assays, real-time PCR, and ELISA, respectively. The statistical power analysis (alpha 0.05; power 0.8; assumed difference in Treg level/function of 30% among groups; based on the data by Myara et al., 2005) revealed that 23 patients (21+2 expected drop-outs) need to be enrolled per patient group. All patients of the non-PLE groups will be sex- and age (plus/minus 5 years)-matched to the PLE subjects. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups |
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| 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 | 92 | ||||||||
| Estimated Completion Date | September 2010 | ||||||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Austria | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00555178 | ||||||||
| Responsible Party | Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria | ||||||||
| Study ID Numbers ICMJE | 18-116 ex 06/07 | ||||||||
| Study Sponsor ICMJE | Medical University of Graz | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Medical University of Graz | ||||||||
| Verification Date | September 2009 | ||||||||
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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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