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Regulatory T Cells (Tregs) in Polymorphic Light Eruption

This study is currently recruiting participants.
Verified February 2013 by Medical University of Graz
Sponsor:
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00555178
First received: November 7, 2007
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  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 and related parameters 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
Polymorphic Light Eruption
Psoriasis
Atopic Eczema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulatory T Cells (Tregs) in Polymorphic Light Eruption

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Treg level and function [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood and/or skin cytokine and chemokine levels, vitamin D status, and other immunoregulatory parameters (see above) [ Time Frame: prospective ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood


Estimated Enrollment: 92
Study Start Date: March 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with polymorphic light eruption without medical photohardening treatment
2
Patients with polymorphic light eruption treated with medical photohardening
3
Patients with other disorders (including psoriasis) treated with phototherapy
4
Normal healthy subjects

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, memory T cells, neutrophils, mast cells, Langerhans cells, cytokine and chemokine profiles, vitamin D levels in the blood and/or skin will be studied in 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). In addition, optional skin biopsies will be taken to study the parameters listed above. 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
Study Population

Primary care clinic patients and community sample

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00555178

Contacts
Contact: Peter Wolf, MD +43 316 385 ext 13254 peter.wolf@medunigraz.at
Contact: Alexandra Gruber-Wackernagel, MD +43 316 385 ext 13254 alexandra.wackernagel@medunigraz.at

Locations
Austria
Medical University of Graz, Department of Dermatology Recruiting
Graz, Austria, 8036
Contact: Peter Wolf, MD     +43 316 385 ext 13254     peter.wolf@medunigraz.at    
Contact: Alexandra Gruber-Wackernagel, MD     +43 316 385 ext 13254     alexandra.wackernagel@medunigraz.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            
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Peter Wolf, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Peter Wolf, MD, Professor of Bioimmunotherapy, Medical University of Graz
ClinicalTrials.gov Identifier: NCT00555178     History of Changes
Other Study ID Numbers: 18-116 ex 06/07
Study First Received: November 7, 2007
Last Updated: February 12, 2013
Health Authority: Austria: Federal Ministry for Health and Women

Keywords provided by Medical University of Graz:
Polymorphic light eruption
Regulatory T cells (Tregs)
Seasonal fluctuation
UV radiation
Phototherapy

Additional relevant MeSH terms:
Dermatitis, Contact
Dermatitis, Atopic
Eczema
Exanthema
Psoriasis
Skin Diseases, Genetic
Genetic Diseases, Inborn
 Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Diseases, Papulosquamous

ClinicalTrials.gov processed this record on May 16, 2013