NCT00555178

Completed

Regulatory T Cells (Tregs) in Polymorphic Light Eruption

Medical University of Graz Source

Other study identifiers

Sponsor study identifier

18-116 ex 06/07

Study Type

observational

Estimated enrollment

92

Locations

1 country

Sites

2

Timeline

Study Start

March 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2014

Actual (reported)

Study Completion

December 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Estimated enrollment: 92 participants
Study completion date: December 2014
Actual (reported)
Listed locations: 1 countries · 2 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 7, 2007
Actual (reported)
First Posted
November 8, 2007
Actual (reported)
Study Start
March 2008
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)
Study Completion
December 2014
Actual (reported)

Last Updated: May 7, 2015
Status Verified: May 2015
Last Update Submitted: May 6, 2015

Conditions

Atopic Eczema Polymorphic Light Eruption Psoriasis

Keywords

Polymorphic light eruptionRegulatory T cells (Tregs)Seasonal fluctuationUV radiationPhototherapy

Outcome Measures

Primary Outcomes (1)

Treg level and function
Prospective

Secondary Outcomes (1)

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

Study Arms (4)

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

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Primary care clinic patients and community sample

You may qualify if:

Age above 18 years

Sponsors & Collaborators

Medical University of Graz
Otherlead

Study Sites (2)

Medical University of Graz, Department of Dermatology

Graz, 8036, Austria

Medical University of Graz

Graz, A-8036, Austria

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

PsoriasisDermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

Peter Wolf, MD
Medical University of Graz
PRINCIPAL INVESTIGATOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor of Bioimmunotherapy

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 8, 2007

Study Start

March 2008

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2014

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Phase 2Completed

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Not ApplicableCompleted

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Not ApplicableUnknown

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Impact of the Severity of Pediatric Psoriasis on Childhood Body Mass Index

Completed

NCT01077882

Analysis of the Quality of Life, the Clinical Effectiveness and Cost-effectiveness of a Novel Educational Programme in Patients With Psoriasis and Atopic Dermatitis

Phase 4Completed

NCT00870285

Ustekinumab Plus UVB-311nm in Psoriasis

Not ApplicableCompleted

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

You may not qualify if:

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)
Pregnancy and breastfeeding
Ongoing or planned specific hyposensitization treatment (i.e. specific immunotherapy)

Contact the study team to confirm eligibility.

Actual (reported)

Study Completion

December 2014

Actual (reported)

Last Updated

May 7, 2015

Record last verified: 2015-05

Source record

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Source: ClinicalTrials.gov.

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Registry identifier: NCT00555178
Data provider: ClinicalTrials.gov
Source updated: 2015-05-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:14 UTC

Locations

AT(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (4)

1

2

3

4

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations