Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases (BioUV2017)
Primary Purpose
Psoriasis, Cutaneous T Cell Lymphoma, Lymphoproliferative Disorders
Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Photo(chemo)therapy
Sponsored by
About this trial
This is an interventional other trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- Age > 18 years
- Skin disorder to be treated with photo(chemo)therapy
Exclusion Criteria:
- Pregnancy and breastfeeding
- Poor general health status
Sites / Locations
- Medical University of Graz, Department of DermatologyRecruiting
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Vitamin D concentration in serum
Vitamin D levels in serum will be assessed by immunoassay
Lipoprotein composition in serum
High density lipoprotein composition in serum will be investigated by proteomics and cholesterol efflux analysis
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
Full Information
NCT ID
NCT03340155
First Posted
October 29, 2017
Last Updated
November 7, 2017
Sponsor
Medical University of Graz
1. Study Identification
Unique Protocol Identification Number
NCT03340155
Brief Title
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
Acronym
BioUV2017
Official Title
Explorative Investigations on the Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2017 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Cutaneous T Cell Lymphoma, Lymphoproliferative Disorders, Eczema, Lichen Planus, Prurigo, Pruritus, Polymorphic Light Eruption, Graft Vs Host Disease, Mastocytosis, Vitiligo
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Biomarker search;
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Photo(chemo)therapy
Intervention Description
Treatment with photo(chemo)therapy, including UVB, UVA, PUVA and photopheresis
Primary Outcome Measure Information:
Title
Correlation of soluble factors in the serum with clinical response, as measured by disease severity
Description
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.
Time Frame
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Title
Correlation of cellular markers of peripheral lymphocytes with clinical response, as measured by disease severity
Description
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.
Time Frame
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Title
Evaluation of T cell receptor repertoire
Description
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.
Time Frame
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Secondary Outcome Measure Information:
Title
Vitamin D concentration in serum
Description
Vitamin D levels in serum will be assessed by immunoassay
Time Frame
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Title
Lipoprotein composition in serum
Description
High density lipoprotein composition in serum will be investigated by proteomics and cholesterol efflux analysis
Time Frame
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Title
microRNA levels in serum
Description
Levels of micro RNA (133, 206 207, 320, 99a, 150, 197 203 220, 423 and others) will be assessed by microarray assays
Time Frame
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 18 years
Skin disorder to be treated with photo(chemo)therapy
Exclusion Criteria:
Pregnancy and breastfeeding
Poor general health status
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Wolf, Dr.
Phone
+43 316 385
Ext
12538
Email
peter.wolf@medunigraz.at
Facility Information:
Facility Name
Medical University of Graz, Department of Dermatology
City
Graz
State/Province
Styria
ZIP/Postal Code
A-8036
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Wolf, MD
Phone
+43 316 385
Ext
80315
Email
peter.wolf@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Angelika Hofer, MD
Phone
+43 316 385
Ext
13254
Email
angelika.hofer@medunigraz.at
First Name & Middle Initial & Last Name & Degree
Peter Wolf, MD
First Name & Middle Initial & Last Name & Degree
Angelika Hofer, MD
First Name & Middle Initial & Last Name & Degree
Franz Legat, MD
First Name & Middle Initial & Last Name & Degree
Regina Fink-Puches, MD
First Name & Middle Initial & Last Name & Degree
Alexandra Gruber-Wackernagel, MD
First Name & Middle Initial & Last Name & Degree
Wolfgang Weger, MD
First Name & Middle Initial & Last Name & Degree
Isabella Bambach
First Name & Middle Initial & Last Name & Degree
Pablo Vieyra-Garcia, PhD
12. IPD Sharing Statement
Learn more about this trial
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
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