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Regulatory T Cells (Tregs) in Polymorphic Light Eruption

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00555178
First Posted: November 8, 2007
Last Update Posted: May 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
  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:


Further study details as provided by Peter Wolf, MD, Medical University of Graz:

Primary Outcome Measures:
  • Treg level and function [ Time Frame: Prospective ]

Secondary Outcome Measures:
  • Blood and/or skin cytokine and chemokine levels, vitamin D status, and other immunoregulatory parameters (see above) [ Time Frame: prospective ]

Biospecimen Retention:   Samples With DNA
Blood

Estimated Enrollment: 92
Study Start Date: March 2008
Study Completion Date: December 2014
Primary Completion Date: December 2014 (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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555178


Locations
Austria
Medical University of Graz, Department of Dermatology
Graz, Austria, 8036
Medical University of Graz
Graz, Austria, A-8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Peter Wolf, MD Medical University of Graz
  More Information

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
First Submitted: November 7, 2007
First Posted: November 8, 2007
Last Update Posted: May 7, 2015
Last Verified: May 2015

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

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