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Regulatory T Cells (Tregs) in Polymorphic Light Eruption

Regulatory T Cells (Tregs) in Polymorphic Light Eruption

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00555178
Enrollment
92
Registered
2007-11-08
Start date
2008-03-31
Completion date
2014-12-31
Last updated
2015-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Eczema, Polymorphic Light Eruption, Psoriasis

Keywords

Polymorphic light eruption, Regulatory T cells (Tregs), Seasonal fluctuation, UV radiation, Phototherapy

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 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.

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.

Interventions

None listed

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frame
Treg level and functionProspective

Secondary

MeasureTime frame
Blood and/or skin cytokine and chemokine levels, vitamin D status, and other immunoregulatory parameters (see above)prospective

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026