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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Sponsor:

Information provided by (Responsible Party):

Peter Wolf, MD, Medical University of Graz

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.

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

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


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Conditions

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Cutaneous T-cell Lymphoma Homologous Wasting Disease Mastocytosis Mast Cell Activation Syndrome Hypomelanotic Disorder

U.S. FDA Resources

Arms and Interventions

Intervention Details:

Other: Photo(chemo)therapy
Treatment with photo(chemo)therapy, including UVB, UVA, PUVA and photopheresis

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age > 18 years
Skin disorder to be treated with photo(chemo)therapy

Exclusion Criteria:

Pregnancy and breastfeeding
Poor general health status

Contacts and Locations

Information from the National Library of Medicine

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

Contacts


Contact: Peter Wolf, Dr.	+43 316 385 ext 12538	peter.wolf@medunigraz.at

Locations


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

Sponsors and Collaborators

Medical University of Graz

More Information


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

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