Plexin B2 Gene Expression and Polymorphisms in Psoriasis : Relation to NB-UVB, Acitretin and Combined Therapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Improve the prognosis of patients with psoriasis Vulgaris
研究概览
简要总结
Patients will be randomly assigned (1:1:1 ) either to ; NB-UVB photo-therapy alone , Acitretin therapy alone or NB-UVB photo-therapy combined with Acitretin therapy randomization will be done by closed envelopes . investigator will be blinded to study drug assignment , while patients and data interpreter will not be masked to study drug assignment.
详细描述
Study Setting: Qena University Hospital, Department of Dermatology ,Venereology& Andrology.
Study subjects: the study will include psoriasis Vulgaris patients who Come to the out patients dermatologic clinic and matching inclusion & exclusion criteria as follow, from 9/2021 up to 3/2023 and then patients will be divided to each group equally as follow:
Group 1: Patients will be treated with NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.
Group 2: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months Group 3: Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
Group 4: 30 healthy individuals un related , age, sex , BMI matched with volunteers.
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
- Single (Participant)
入排标准
- 年龄范围
- 24 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of both sexes. Diagnosed clinically with moderate to severe Psoriasis Vulgaris.
- •patients able to swallow tablet and receive Narrow band Ultraviolet B phototherapy without any contraindication
排除标准
- •Pregnancy , lactation & women intent to become pregnant within 3 year after discontinuation of acitretin Patients with Hyperlipidemia Patients with mental problems and depression Patients with a history of malignancies, renal & liver diseases. Patients with a history of any inflammatory diseases as atopic dermatitis , asthma ulcerative colitis ) and Crohn's disease Patients received NB-UVB phototherapy in the last 6 months. Patients treated with methotrexate or biologic agents and any systemic treatment of psoriasis.
研究组 & 干预措施
Narrow band Ultraviolet B phototherapy group
Patients will be treated with Narrow band Ultraviolet B phototherapy 3 sessions weekly for 3 months with maximum dose of 1400 mJ/cm2.
干预措施: Narrow band Ultraviolet B phototherapy group (Radiation)
Acitretin group
Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally for 3 months
干预措施: Acitretin group (Drug)
Acitretin plus Narrow band Ultraviolet B phototherapy group
Patients will be treated with Acitretin in dose of 0.5-1 mg per kg per day orally plus NB-UVB phototherapy 3 sessions weekly for 3 months with maximum dose 1400 mJ/cm2.
干预措施: Acitretin plus Narrow band Ultraviolet B phototherapy group (Combination Product)
结局指标
主要结局
Improve the prognosis of patients with psoriasis Vulgaris
时间窗: 3 month
detect the effect of Acitretin alone and Narrow band Ultraviolet B phototherapy alone versus combined therapy on genetic mutation and level of plexin b2 in patients with psoriasis Vulgaris
次要结局
- Improve the clinical out comes of patients with psoriasis Vulgaris(12 month)
研究者
Ebtehal alaa el Dean kotop Mohamed, MD
Assitant lecturer of Dermatology, Venereology & Andrology
South Valley University