Clinical trial NCT03340155: Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
Official title: Explorative Investigations on the Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Cutaneous T Cell Lymphoma
Lymphoproliferative Disorders
Eczema
Lichen Planus
Prurigo
Pruritus
Polymorphic Light Eruption
Graft Vs Host Disease
Mastocytosis
Vitiligo
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Biomarker search;
Primary purpose: OTHER

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.

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnancy and breastfeeding
* Poor general health status

Primary outcomes:
measure: Correlation of soluble factors in the serum with clinical response, as measured by disease severity
timeFrame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
measure: Correlation of cellular markers of peripheral lymphocytes with clinical response, as measured by disease severity
timeFrame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
measure: Evaluation of T cell receptor repertoire
timeFrame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Secondary outcomes:
measure: Vitamin D concentration in serum
timeFrame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
measure: Lipoprotein composition in serum
timeFrame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
measure: microRNA levels in serum
timeFrame: Day 14 to 0; week 4; week 8-12; week 12-16 (or month 6-12 for photopheresis)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz, Department of Dermatology
state: Styria
Study officials:
References: