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Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases (BioUV2017)

This study is currently recruiting participants.
Verified November 2017 by Peter Wolf, MD, Medical University of Graz
Sponsor:
ClinicalTrials.gov Identifier:
NCT03340155
First Posted: November 10, 2017
Last Update Posted: November 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Peter Wolf, MD, Medical University of Graz
  Purpose
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 Intervention
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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Peter Wolf, MD, Medical University of Graz:

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


Estimated Enrollment: 240
Actual Study Start Date: October 30, 2017
Estimated Study Completion Date: October 2022
Estimated Primary Completion Date: October 2022 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Photo(chemo)therapy
    Treatment with photo(chemo)therapy, including UVB, UVA, PUVA and photopheresis
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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 Submitted: October 29, 2017
First Posted: November 10, 2017
Last Update Posted: November 10, 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
Lymphoproliferative Disorders
Vitiligo
Skin Diseases
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