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

Psoriasis Clinical Trial

— BioUV2017  

Official title:

Explorative Investigations on the Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03340155
• Other study ID #: Graz IRB# 29-609 ex 16/17
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2017
• Last updated: November 7, 2017
• Start date: October 30, 2017
• Est. completion date: October 2022

Study information

• Verified date: November 2017
• Source: Medical University of Graz
• Contact: Peter Wolf, Dr.
• Phone: +43 316 385
• Email: peter.wolf[@]medunigraz.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Skin disorder to be treated with photo(chemo)therapy

Exclusion Criteria:

• Pregnancy and breastfeeding

• Poor general health status

Related Conditions & MeSH terms

• Cutaneous T Cell Lymphoma
• Dermatitis, Contact
• Eczema
• Graft Vs Host Disease
• Lichen Planus
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Cutaneous
• Lymphoproliferative Disorders
• Mastocytosis
• Polymorphic Light Eruption
• Prurigo
• Pruritus
• Psoriasis
• Skin Diseases
• Vitiligo

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Graz, Department of Dermatology	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Vitamin D concentration in serum	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)
Secondary	Lipoprotein composition in serum	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)
Secondary	microRNA levels in serum	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)