NCT00555178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2008

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 7, 2015

Status Verified

May 1, 2015

Enrollment Period

6.8 years

First QC Date

November 7, 2007

Last Update Submit

May 6, 2015

Conditions

Polymorphic Light EruptionPsoriasisAtopic Eczema

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
  • 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.

Sponsors & Collaborators

Study Sites (2)

Medical University of Graz, Department of Dermatology

Graz, 8036, Austria

Location

Medical University of Graz

Graz, A-8036, Austria

Location

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 1, 2008

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

May 7, 2015

Record last verified: 2015-05

Locations

AU(2)