Evaluation The Effect of NB-UVB and Methotrexate on The Level of Serum Gelsolin in Psoriatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Treatment of the Psoriasis
研究概览
简要总结
Psoriasis is a common chronic, immune-mediated, skin disease with a significantly negative impact on patients' quality of life. It is one of papulosquamous diseases defined by erythematous plaques with silvery scales.
The interplay among cytokines released by dendritic, Th1, Th2, and Th17 cells leads to the clinical manifestations seen in psoriasis. Although discovering novel biomarkers for psoriasis is challenging step., it may play an essential role in diagnosis, severity assessment and prediction of treatment outcome and prognosis of the disease
详细描述
The protein expression of gelsolin- which is an actin scavenger controlling cytoskeletal remodeling, cell morphology, differentiation, movement, and apoptosis- has been found to be significantly decreased in several pathological conditions including neurodegenerative diseases, inflammatory disorders, and cancers.
Gelsolin (GSN) is a member of the GSN protein family, the main function of it is to cut and seal actin filaments to regulate the cytoskeleton and participate in a variety of biological functions.
Low serum gelsolin levels are linked to the severity of psoriasis, suggesting that gelsolin may help in assessing the severity of the disease and how it responds to treatment.
Methotrexate (MTX) is the first-choice drug when phototherapy or retinoid treatment are not effective in psoriatic patients.
It is a cytotoxic drug with powerful anti-proliferative and anti-inflammatory effects that has gained prominence in treating inflammatory diseases one of them is psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with moderate to severe plaque psoriasis.
- •No restriction of age, race nor occupation.
排除标准
- •History of psoriasis treatment with systemic and biological agents prior to the study for at least 3 months.
- •Pregnancy and lactation.
- •Infections.
- •Patients with chronic diseases: hepatic disorders, hematologic diseases, chronic renal failure or cancer.
研究组 & 干预措施
Group A: (Narrow Band Ultraviolet B)
About 12 patients will expose to 24 sessions of Narrow Band Ultraviolet B (NB-UVB) radiation (initial dose of 130 - 400 mJ / cm2 ) selected according to skin for 3 month.
干预措施: NB-UVB (Procedure)
Group B: (Methotrexate )
About 12 patients will receive Methotrexate tablets (MTX) in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) for 3 month.
干预措施: NB-UVB (Procedure)
Group C: (Methotrexate and Narrow Band Ultraviolet B)
About 12 patients will undergo the treatment by both Methotrexate tablets (MTX) and Narrow Band Ultraviolet B( NB-UVB) radiation.for 3 month.
干预措施: NB-UVB (Procedure)
Group D (Control Group)
About 12 patients apparently healthy individuals as control group.and will not take any medication
干预措施: NB-UVB (Procedure)
结局指标
主要结局
Treatment of the Psoriasis
时间窗: 3 months
About 36 patients suffering from Psoriasis and will be treated by exposing to Narrow band ultraviolet B radiation (initial dose of 130 - 400 mJ / cm2 selected according to skin phototype and gradual increase after each session ), and taking Methotrexate tablets in dose of (0.3 mg/kg/week) along with folic acid (5 mg/day) .
Serum Gelsolin Evaluation
时间窗: 3 Months
Evaluation the Serum Gelsolin level in Psoriatic Patients after treatment by Narrow band ultraviolet B and taking Methotrexate tablets.
次要结局
未报告次要终点
研究者
Nourhan Salah Mohamed
Resident of Dermatology, Venereology and Andrology
Aswan University