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

November 7, 2017 updated by: Peter Wolf, MD, Medical University of Graz

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, A-8036
        • Recruiting
        • Medical University of Graz, Department of Dermatology
        • Sub-Investigator:
          • Angelika Hofer, MD
        • Sub-Investigator:
          • Franz Legat, MD
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Wolf, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy and breastfeeding
  • Poor general health status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
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.
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
High density lipoprotein composition in serum will be investigated by proteomics and cholesterol efflux analysis
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)
Levels of micro RNA (133, 206 207, 320, 99a, 150, 197 203 220, 423 and others) will be assessed by microarray assays
Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 30, 2017

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

October 29, 2017

First Submitted That Met QC Criteria

November 7, 2017

First Posted (Actual)

November 13, 2017

Study Record Updates

Last Update Posted (Actual)

November 13, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Graz IRB# 29-609 ex 16/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lymphoproliferative Disorders

Clinical Trials on Photo(chemo)therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe