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| Sponsored by: |
Medical University of Graz |
| Information provided by: | Medical University of Graz |
| ClinicalTrials.gov Identifier: | NCT00555178 |
Purpose
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.
| Condition |
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Polymorphic Light Eruption Psoriasis Atopic Eczema |
| MedlinePlus related topics: | Eczema Psoriasis Rashes |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | Regulatory T Cells (Tregs) in Polymorphic Light Eruption |
Blood
| Estimated Enrollment: | 92 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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1
Patients with polymorphic light eruption without medical photohardening treatment
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2
Patients with polymorphic light eruption treated with medical photohardening
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3
Patients with other disorders (including psoriasis) treated with phototherapy
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4
Normal healthy subjects
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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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Primary care clinic patients and community sample
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Peter Wolf, MD | +43 316 385 ext 3254 | peter.wolf@meduni-graz.at |
| Contact: Alexandra Gruber-Wackernagel, MD | +43 316 385 ext 3254 | alexandra.wackernagel@meduni-graz.at |
| Austria | |||||
| Medical University of Graz, Department of Dermatology | Recruiting | ||||
| Graz, Austria, 8036 | |||||
| Contact: Peter Wolf, MD +43 316 385 ext 3254 peter.wolf@meduni-graz.at | |||||
| Contact: Alexandra Gruber-Wackernagel, MD +43 316 385 ext 3254 alexandra.wackernagel@meduni-graz.at | |||||
| Principal Investigator: Peter Wolf, MD | |||||
| Sub-Investigator: Alexandra Gruber-Wackernagel, MD | |||||
| Sub-Investigator: Franz Legat, MD | |||||
| Sub-Investigator: Angelika Hofer, MD | |||||
| Medical University of Graz | Recruiting | ||||
| Graz, Austria, A-8036 | |||||
| Principal Investigator: Peter Wolf, MD | |||||
| Medical University of Graz |
| Principal Investigator: | Peter Wolf, MD | Medical University of Graz |
More Information
| Responsible Party: | Medical University of Graz, Austria ( Peter Wolf, MD, Principal Investigator ) |
| Study ID Numbers: | 18-116 ex 06/07 |
| First Received: | November 7, 2007 |
| Last Updated: | March 10, 2008 |
| ClinicalTrials.gov Identifier: | NCT00555178 |
| Health Authority: | Austria: Federal Ministry for Health and Women |
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