Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases (BioUV2017)
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ClinicalTrials.gov Identifier: NCT03340155 |
Recruitment Status
:
Recruiting
First Posted
: November 13, 2017
Last Update Posted
: November 13, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Psoriasis Cutaneous T Cell Lymphoma Lymphoproliferative Disorders Eczema Lichen Planus Prurigo Pruritus Polymorphic Light Eruption Graft Vs Host Disease Mastocytosis Vitiligo | Other: Photo(chemo)therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 240 participants |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Biomarker search; |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | Explorative Investigations on the Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases |
Actual Study Start Date : | October 30, 2017 |
Estimated Primary Completion Date : | October 2022 |
Estimated Study Completion Date : | October 2022 |

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Other: Photo(chemo)therapy
- 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.
- 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) ]Vitamin D levels in serum will be assessed by immunoassay
- Lipoprotein composition in serum [ Time Frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis) ]High density lipoprotein composition in serum will be investigated by proteomics and cholesterol efflux analysis
- microRNA levels in serum [ Time Frame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis) ]Levels of micro RNA (133, 206 207, 320, 99a, 150, 197 203 220, 423 and others) will be assessed by microarray assays

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age > 18 years
- Skin disorder to be treated with photo(chemo)therapy
Exclusion Criteria:
- Pregnancy and breastfeeding
- Poor general health status

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03340155
Contact: Peter Wolf, Dr. | +43 316 385 ext 12538 | peter.wolf@medunigraz.at |
Austria | |
Medical University of Graz, Department of Dermatology | Recruiting |
Graz, Styria, Austria, A-8036 | |
Contact: Peter Wolf, MD +43 316 385 ext 80315 peter.wolf@medunigraz.at | |
Contact: Angelika Hofer, MD +43 316 385 ext 13254 angelika.hofer@medunigraz.at | |
Principal Investigator: Peter Wolf, MD | |
Sub-Investigator: Angelika Hofer, MD | |
Sub-Investigator: Franz Legat, MD | |
Sub-Investigator: Regina Fink-Puches, MD | |
Sub-Investigator: Alexandra Gruber-Wackernagel, MD | |
Sub-Investigator: Wolfgang Weger, MD | |
Sub-Investigator: Isabella Bambach | |
Sub-Investigator: Pablo Vieyra-Garcia, PhD |
Responsible Party: | Peter Wolf, MD, Professor of Dermatology, Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT03340155 History of Changes |
Other Study ID Numbers: |
Graz IRB# 29-609 ex 16/17 |
First Posted: | November 13, 2017 Key Record Dates |
Last Update Posted: | November 13, 2017 |
Last Verified: | November 2017 |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoma, Non-Hodgkin Lymphoma Psoriasis Pruritus Vitiligo Skin Diseases Lymphoproliferative Disorders Graft vs Host Disease Lichen Planus Mastocytosis Prurigo Dermatitis, Contact Skin Diseases, Papulosquamous |
Neoplasms by Histologic Type Neoplasms Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Skin Manifestations Signs and Symptoms Hypopigmentation Pigmentation Disorders Lichenoid Eruptions Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Dermatitis Skin Diseases, Eczematous |