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临床试验/NCT03874975
NCT03874975Unknown早期 1 期

Combined Oral Vitamin D and UVB Versus Alone in Treatment of Psoroasis Vulgaris

Assiut University0 个研究点目标入组 40 人开始时间: 2019年4月1日最近更新:
适应症
相关药物

试验速览

阶段
早期 1 期
入组人数
40
主要终点
measure serum vitamin D before and after treatment in psoriatic patients

研究概览

简要总结

To compare the results of vitamin D plus UVB in treatment of psoriasis vulgaris with the results of UVB alone to study the relation between serum vitamin D and PASI score before and after treatment.

详细描述

Psoriasis is a chronic immune-mediated inflammatory skin disease, with a prevalence of about 2%-3% in the general population. The primary manifestation of psoriasis most commonly manifests on the skin, although inflammatory processes can occur also in other organs .

Vitamin D, also known as the sunshine vitamin, has long been known to be a hormone that regulates calcium-phosphorous homeostasis and safeguards the integrity of the skeletal system . The epidermis is the natural source of vitamin D synthesis by the action of ultraviolet light (UV) B of the sun or other UVB source . On the other hand, evidence is accumulating that vitamin D might represent a key modulator of immune and inflammation mechanisms . Recently, a role for vitamin D in the pathogenesis of different skin diseases, including psoriasis, has been reported.

Psoriasis lesions are characterized by hyper-proliferation with incomplete differentiation of epidermal keratinocytes and decreased keratinocyte apoptosis, associated with inflammatory cellular infiltrate in both dermis and epidermis . Psoriasis Area and Severity Index (PASI) score is currently the preferred method for the assessment of the disease severity and extent .

Physiologically, the active form of vitamin D and its receptor regulate the differentiation and proliferation of keratinocytes, the balance of the cutaneous immune system and the process of apoptosis.

Several studies identified an association between polymorphisms of vitamin D receptor (VDR) and psoriasis susceptibility .The 1,25(OH)D has been shown to exert anti-proliferative effects on keratinocytes .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
10 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • : patients from 10 to 60 diagnosed to have psoriasis vulgaris

排除标准

  • concomitant chronic inflammatory disease or malignancy.
  • pregnant and lactating women.
  • renal dysfunction.

结局指标

主要结局

measure serum vitamin D before and after treatment in psoriatic patients

时间窗: 1 year

A 3ml blood sample will be collected from the patients, then allowed to clot for 10 minutes and then centrifuged . Group 1: 20 patients under oral vitamin D therapy ( oral alpha one for 3 months o.25 microgram / day ) in combination with narrow band UVB settings (twice/week) Group 2 : 20 patients under narrow band UVB therapy only . c) We evaluate psoriatic patient by PASI score before and after treatment : ) measurment vitamin D level before and after treatment.

次要结局

  • We evaluate psoriatic patient by PASI score before and after treatment :(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Meryhan Ashraf Abdelazeem

principal Investigator

Assiut University

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