Polymorphic Light EruptionNCT00555178
Regulatory T Cells (Tregs) in Polymorphic Light Eruption
An observational study of Polymorphic Light Eruption and Psoriasis, run by Medical University of Graz at 2 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Polymorphic Light Eruption, Psoriasis, Atopic Eczema
- How many people
- 92 participants
- Where
- 2 sitesAustria
- Study dates
- Mar 2008to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic patients and community sample
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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)
Trial locations and contacts
2 sites in 1 country.
Austria2 sites
Medical University of Graz, Department of Dermatology
Graz, 8036
Medical University of Graz
Graz, A-8036
About this study
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.
Read the 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.
- Conditions
- Polymorphic Light Eruption, Psoriasis, Atopic Eczema
- Keywords
- Polymorphic light eruption, Regulatory T cells (Tregs), Seasonal fluctuation, UV radiation, Phototherapy
- Medical subject headings
- Psoriasis, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treg level and function
Measured: Prospective
Secondary outcomes (1)
Blood and/or skin cytokine and chemokine levels, vitamin D status, and other immunoregulatory parameters (see above)
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startMar 2008
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polymorphic Light EruptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Wolf, MD, Medical University of Graz
- Investigators
- Peter Wolf, MD, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555178
- Sponsor's protocol ID
- 18-116 ex 06/07
- Status last verified
- May 2015
- First submitted
- 7 Nov 2007
- Last updated
- 7 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulatory T Cells (Tregs) in Polymorphic Light Eruption
- ClinicalTrials.gov ID
- NCT00555178
- Acronym / sponsor ID
- 18-116 ex 06/07
- Conditions
- Polymorphic Light Eruption, Psoriasis, Atopic Eczema
- Keywords
- Polymorphic light eruption, Regulatory T cells (Tregs), Seasonal fluctuation, UV radiation, Phototherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic patients and community sample
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Treg level and function
Time frame: Prospective
1 secondary outcome
Blood and/or skin cytokine and chemokine levels, vitamin D status, and other immunoregulatory parameters (see above)
Time frame: prospective
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Wolf, MD principal investigator
Medical University of Graz
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymorphic Light Eruption and Psoriasis, run by Medical University of Graz at 2 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treg level and function (time frame: Prospective). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2015.