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Regulatory T Cells (Tregs) in Polymorphic Light Eruption
This study is currently recruiting participants.
Study NCT00555178   Information provided by Medical University of Graz
First Received: November 7, 2007   Last Updated: September 29, 2009   History of Changes

November 7, 2007
September 29, 2009
March 2008
September 2010   (final data collection date for primary outcome measure)
Treg level and function [ Time Frame: Prospective ] [ Designated as safety issue: No ]
Treg level and function [ Time Frame: Prospective ]
Complete list of historical versions of study NCT00555178 on ClinicalTrials.gov Archive Site
Blood cytokine levels [ Time Frame: prospective ] [ Designated as safety issue: No ]
Blood cytokine levels [ Time Frame: prospective ]
 
Regulatory T Cells (Tregs) in Polymorphic Light Eruption
Regulatory T Cells (Tregs) in Polymorphic Light Eruption

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.

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.

 
Observational
Cohort, Prospective
  • Polymorphic Light Eruption
  • Psoriasis
  • Atopic Eczema
 
  • Patients with polymorphic light eruption without medical photohardening treatment
  • Patients with polymorphic light eruption treated with medical photohardening
  • Patients with other disorders (including psoriasis) treated with phototherapy
  • Normal healthy subjects
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
92
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age above 18 years
  • Patients with confirmed PLE diagnosis either by typical anamnesis and/or typical histology of lesions and/or positive phototesting results (group 1 and 2); healthy subjects (group 3); patients with phototherapy-responsive disease (including psoriasis, atopic dermatitis, and other conditions (group 4).
  • Good general health status

Exclusion Criteria:

  • Presence or history of malignant skin tumors
  • Dysplastic melanocytic nevus syndrome
  • Certain photosensitive disorders (including porphyria, chronic actinic dermatitis, Xeroderma pigmentosum, basal cell nevus syndrome)
  • Autoimmune disease (lupus erythematodes, scleroderma, dermatomyositis)
  • Systemic treatment with steroids and/or other immunosuppressive drugs within the last 6 months
  • Antinuclear antibodies (ds-DNA, Ro, La)
  • First-degree relatives of PLE patients (exclusion criterion for group 3 and 4
  • Pregnancy and breastfeeding
  • Ongoing or planned specific hyposensitization treatment (i.e. specific immunotherapy)
Both
18 Years and older
Yes
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
 
NCT00555178
Peter Wolf, MD, Principal Investigator, Medical University of Graz, Austria
18-116 ex 06/07
Medical University of Graz
 
Principal Investigator: Peter Wolf, MD Medical University of Graz
Medical University of Graz
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP