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

NCT03340155 | Unknown

• 1 other identifier: Graz IRB# 29-609 ex 16/17
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis; Cutaneous T Cell Lymphoma; Lymphoproliferative Disorders; Eczema; Lichen Planus; Prurigo; Pruritus; Polymorphic Light Eruption; Graft Vs Host Disease; Mastocytosis; Vitiligo

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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

  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 Outcomes (3)

• Vitamin D concentration in serum

  Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)

• Lipoprotein composition in serum

  Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)

• microRNA levels in serum

  Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)

Interventions

Photo(chemo)therapy OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pregnancy and breastfeeding
• Poor general health status

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz, Department of Dermatology

Graz, Styria, A-8036, Austria

RECRUITING

MeSH Terms

Conditions

Psoriasis; Lymphoma, T-Cell, Cutaneous; Lymphoproliferative Disorders; Eczema; Lichen Planus; Prurigo; Pruritus; Graft vs Host Disease; Mastocytosis; Vitiligo

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Dermatitis; Skin Diseases, Eczematous; Lichenoid Eruptions; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Mast Cell Activation Disorders; Hypopigmentation; Pigmentation Disorders

Central Study Contacts

Peter Wolf, Dr.

CONTACT

+43 316 385; peter.wolf@medunigraz.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Dermatology

Model Details: Biomarker search;

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: November 13, 2017
• Study Start: October 30, 2017
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

AU (1)