Explorative Investigations on the Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Correlation of soluble factors in the serum with clinical response, as measured by disease severity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Skin disorder to be treated with photo(chemo)therapy
排除标准
- •Pregnancy and breastfeeding
- •Poor general health status
结局指标
主要结局
Correlation of soluble factors in the serum with clinical response, as measured by disease severity
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Peter Wolf, MD
Professor of Dermatology
Medical University of Graz