PsoriasisBioUV2017NCT03340155
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
A study testing Photo(chemo)therapy in people with Psoriasis and Cutaneous T Cell Lymphoma, run by Medical University of Graz at 1 site in Austria.
Trial summary
The molecular mechanisms of action of photo(chemo)therapy in skin diseases are investigated in this study. The phototherapeutic modalities employed include UVB (ultraviolet B), UVA (ultraviolet A), PUVA (psoralen+UVA) and/or extracorporeal photochemotherapy (photopheresis). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis, Cutaneous T Cell Lymphoma, Lymphoproliferative Disorders
- What is being tested?
- Photo(chemo)therapy
- How many people
- 240 participants
- Where
- 1 siteAustria
- Study dates
- 30 Oct 2017to Oct 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Skin disorder to be treated with photo(chemo)therapy
Who cannot join
- Pregnancy and breastfeeding
- Poor general health status
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz, Department of Dermatology
Graz, Styria, A-8036
Peter Wolf, MD, +43 316 385 ext. 80315, peter.wolf@medunigraz.at
Angelika Hofer, MD, +43 316 385 ext. 13254, angelika.hofer@medunigraz.at
About this study
Official title: Explorative Investigations on the Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
The molecular mechanisms of action of photo(chemo)therapy in skin diseases are investigated in this study. The phototherapeutic modalities employed include UVB (ultraviolet B), UVA (ultraviolet A), PUVA (psoralen+UVA) and/or extracorporeal photochemotherapy (photopheresis). The study will address whether and how photo(chemo)therapy affects specific biologic pathways in different skin disorders and search for predictive biomarkers.
Read the detailed description
This study is performed in order to investigate the molecular mechanisms of action of photo(chemo)therapy in skin diseases, including psoriasis, cutaneous T-cell lymphoma, other lymphoproliferative disorders of the skin, eczema, lichen planus, prurigo/pruritus, polymorphic light eruption, mastocytosis, graft-versus-host disease, vitiligo and other photo(chemo)therapy-responsive diseases. Twenty patients will be enrolled per diagnosis group. The phototherapeutic modalities administered will be UVB, UVA, PUVA and/or extracorporeal photochemotherapy (photopheresis). The severity of disease and clinical response to treatment will be assessed with scores including dermatological quality of life (DLQI) and disease-specific scores such as PASI (psoriasis area and severity index), mSWAT (modified severity-weighted assessment tool), SCORAD (scoring atopic dermatitis), scleroderma score and/or different visual analog scale (VAS) scores for pruritus. The effect of treatment on a variety of laboratory endpoints will be investigated in blood samples and optionally also skin samples. Those endpoints include among others the regulation of cytokines/chemokines, immune function, clonality of immune cells, vitamin D, and serum lipids. The study will address whether and how photo(chemo)therapy affects specific biologic pathways in the different disorders and determine whether predictive biomarkers for therapeutic response exist.
- Conditions
- Psoriasis, Cutaneous T Cell Lymphoma, Lymphoproliferative Disorders, Eczema, Lichen Planus, Prurigo
- Being tested
- Photo(chemo)therapy
- Medical subject headings
- Psoriasis, Lymphoma, T-Cell, Cutaneous, Lymphoproliferative Disorders, Eczema, Lichen Planus, Prurigo, Pruritus, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photo(chemo)therapyOther
Treatment with photo(chemo)therapy, including UVB, UVA, PUVA and photopheresis
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of soluble factors in the serum with clinical response, as measured by disease severity
Serum levels of cytokines, chemokine and other factors, as measured in pg/ml, will be correlated to the clinical response to treatment at the time points specified below to identify potential predictive biomarkers. Disease-specific scores such as PASI, mSWAT, SCORAD, scleroderma score and VAS pruritus scores will be used depending on the condition to carry-out correlation analysis, comparing the change from baseline to end of observation.
Measured: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Correlation of cellular markers of peripheral lymphocytes with clinical response, as measured by disease severity
Expression of cellular markers including CD (cluster of differentiation) 1a, CD3, CD4, CD8, CD11c, CD25, CD45, CD56, CD68, CD103, CD163, FoxP3, as measured by flow cytometry will be correlated to the clinical response to treatment at the time points specified below to identify potential predictive biomarkers. Disease-specific scores such as PASI, mSWAT, SCORAD, scleroderma score and VAS pruritus scores will be used depending on the condition to carry-out correlation analysis, comparing the change from baseline to end of observation.
Measured: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Evaluation of T cell receptor repertoire
Diversity of the T cell repertoire will be assessed by high-throughput sequencing of the T cell receptor and correlated to the clinical response to treatment at the time points specified below to identify its potential predictive value. Disease-specific scores such as PASI, mSWAT, SCORAD, scleroderma score and VAS pruritus scores will be used depending on the condition to carry-out correlation analysis, comparing the change from baseline to end of observation.
Measured: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Secondary outcomes (3)
Vitamin D concentration in serum
Vitamin D levels in serum will be assessed by immunoassay
Measured: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Lipoprotein composition in serum
High density lipoprotein composition in serum will be investigated by proteomics and cholesterol efflux analysis
Measured: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
microRNA levels in serum
Levels of micro RNA (133, 206 207, 320, 99a, 150, 197 203 220, 423 and others) will be assessed by microarray assays
Measured: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start30 Oct 2017
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Biomarker search;
- Masking
- None (open label)
- Enrolment
- 240 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340155
- Sponsor's protocol ID
- Graz IRB# 29-609 ex 16/17
- Acronym
- BioUV2017
- Status last verified
- Nov 2017
- First submitted
- 29 Oct 2017
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Investigations on the Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
- ClinicalTrials.gov ID
- NCT03340155
- Acronym / sponsor ID
- BioUV2017 / Graz IRB# 29-609 ex 16/17
- Conditions
- Psoriasis, Cutaneous T Cell Lymphoma, Lymphoproliferative Disorders, Eczema, Lichen Planus, Prurigo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 13 Nov 2017 (actual)
- 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.
The molecular mechanisms of action of photo(chemo)therapy in skin diseases are investigated in this study. The phototherapeutic modalities employed include UVB (ultraviolet B), UVA (ultraviolet A), PUVA (psoralen+UVA) and/or extracorporeal photochemotherapy (photopheresis). The study will address whether and how photo(chemo)therapy affects specific biologic pathways in different skin disorders and search for predictive biomarkers.
Detailed description
This study is performed in order to investigate the molecular mechanisms of action of photo(chemo)therapy in skin diseases, including psoriasis, cutaneous T-cell lymphoma, other lymphoproliferative disorders of the skin, eczema, lichen planus, prurigo/pruritus, polymorphic light eruption, mastocytosis, graft-versus-host disease, vitiligo and other photo(chemo)therapy-responsive diseases. Twenty patients will be enrolled per diagnosis group. The phototherapeutic modalities administered will be UVB, UVA, PUVA and/or extracorporeal photochemotherapy (photopheresis). The severity of disease and clinical response to treatment will be assessed with scores including dermatological quality of life (DLQI) and disease-specific scores such as PASI (psoriasis area and severity index), mSWAT (modified severity-weighted assessment tool), SCORAD (scoring atopic dermatitis), scleroderma score and/or different visual analog scale (VAS) scores for pruritus. The effect of treatment on a variety of laboratory endpoints will be investigated in blood samples and optionally also skin samples. Those endpoints include among others the regulation of cytokines/chemokines, immune function, clonality of immune cells, vitamin D, and serum lipids. The study will address whether and how photo(chemo)therapy affects specific biologic pathways in the different disorders and determine whether predictive biomarkers for therapeutic response exist.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Biomarker search;
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years
- Skin disorder to be treated with photo(chemo)therapy
Key exclusion criteria (2 listed)
- Pregnancy and breastfeeding
- Poor general health status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Photo(chemo)therapyTreatment with photo(chemo)therapy, including UVB, UVA, PUVA and photopheresis | Other | – |
Primary outcome
Correlation of soluble factors in the serum with clinical response, as measured by disease severity
Time frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Serum levels of cytokines, chemokine and other factors, as measured in pg/ml, will be correlated to the clinical response to treatment at the time points specified below to identify potential predictive biomarkers. Disease-specific scores such as PASI, mSWAT, SCORAD, scleroderma score and VAS pruritus scores will be used depending on the condition to carry-out correlation analysis, comparing the change from baseline to end of observation.
Correlation of cellular markers of peripheral lymphocytes with clinical response, as measured by disease severity
Time frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Expression of cellular markers including CD (cluster of differentiation) 1a, CD3, CD4, CD8, CD11c, CD25, CD45, CD56, CD68, CD103, CD163, FoxP3, as measured by flow cytometry will be correlated to the clinical response to treatment at the time points specified below to identify potential predictive biomarkers. Disease-specific scores such as PASI, mSWAT, SCORAD, scleroderma score and VAS pruritus scores will be used depending on the condition to carry-out correlation analysis, comparing the change from baseline to end of observation.
Evaluation of T cell receptor repertoire
Time frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Diversity of the T cell repertoire will be assessed by high-throughput sequencing of the T cell receptor and correlated to the clinical response to treatment at the time points specified below to identify its potential predictive value. Disease-specific scores such as PASI, mSWAT, SCORAD, scleroderma score and VAS pruritus scores will be used depending on the condition to carry-out correlation analysis, comparing the change from baseline to end of observation.
3 secondary outcomes
Vitamin D concentration in serum
Time frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Lipoprotein composition in serum
Time frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
microRNA levels in serum
Time frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photo(chemo)therapy in people with Psoriasis and Cutaneous T Cell Lymphoma, run by Medical University of Graz at 1 site 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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peter Wolf, Dr. (+43 316 385 ext. 12538, peter.wolf@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of soluble factors in the serum with clinical response, as measured by disease severity (time frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)). The study lists 3 primary outcomes in all. 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 13 Nov 2017.