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临床试验/NCT04320160
NCT04320160Unknown不适用

Structural Evaluation of Human Melanocytes After the Use of Autologous Platelet-rich Plasma (PRP) Versus Fractional Carbon Dioxide Laser (Fr:CO2 Laser) in Treatment of Vitiligo: (A Histological, Immunohistochemical and Molecular Study )

Assiut University0 个研究点目标入组 30 人开始时间: 2020年8月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
melanocyte cell quantification by light microscope

研究概览

简要总结

Vitiligo is considered the most common chronic depigmentation disorder that affects around 0.5 -2% of the world population . In Africa , its prevelance is around 0.4% and 1.22 % in Assiut .

Treatment of vitiligo includes medical topical and systemic immune -suppressants ,phototherapy and surgical modalities .Despite the numerous treatment options , the treatment of choice is still controversial as the response is variable , unsatisfactory ,and requires a prolonged course. Therefore, new therapeutic approaches are required .

Platelet -rich plasma (PRP) is a treatment modality which has been used over the last several years in various medical and surgical fields . It is composed of high concentration of platelets , several growth factors and plasma proteins such as fibrin, fironectin ,vitronectin .This is hypothesized to stimulate keratinocytes and fibroblasts proliferation .

Another treatment modality is the fractional CO2 (Fr: CO2) laser .There are theories that fractional CO2 laser causes release of various types of cytokines and growth factors that can stimulate migration of melanocytes and act as mitogens for melanogenesis .

Melanogenesis is a complex process with involvement of multiple signaling pathways. Therefore, there have been extensive efforts to reveal the molecular mechanisms that control melanogenesis as the main step for treating hypopigmentary skin disorders .

There is yet very limited histopathological and molecular information about how the signaling networks are involved in the initiation , progression and also treatment of vitiligo disease.

详细描述

Vitiligo is considered the most common chronic depigmentation disorder that affects around 0.5 -2% of the world population .In Africa , its prevelance is around 0.4% and 1.22 % in Assiut .

Vitiligo may appear at any age and affect both sexes. It is a cosmetically disfiguring disorder characterized by formation of depigmented patches of skin and /or mucosa.It has a psychological devastating effect which could lead to low self-steam and poor body image .

Vitiligo disease has three types according to the distribution of lesions ; segmental, non-segmental and mixed vitiligo .It could be classified as progressing or stable according to the activity of the disease .

Vitiligo pathogenesis includes many theories (the combination theory). The important theories include: autoimmune destruction of melanocytes, genetic predisposition , altered redox status and free radical mediated melanocyte damage , impaired melanocyte adhesion or melanocytorrhagy and heightened sympathetic response and catecholamines/ neurotransmitter mediated melanocyte damage .

The treatment of vitiligo depends upon the clinical diagnosis and usually includes two strategies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

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

入选标准

  • Age from 20-60 years old
  • Avoid using any other treatment modalities for vitiligo during the course of the study

排除标准

  • Pregnant and lactating women
  • local medications or laser therapy one month prior to the study
  • bleeding disorders
  • history of keloid formation
  • photosensitivity
  • seizure disorders

结局指标

主要结局

melanocyte cell quantification by light microscope

时间窗: 1 year

Punch biopsy specimens will be stained by special immunohistochemical stain of Melan A antibody marker then counting melanocyte cells per field in five non overlapping fields using NIKON camera attached to a light microscope

次要结局

  • Mean improvement score by physician (MISP)(1 year)

研究者

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

Reham ElGibaly

Assistant lecturer

Assiut University

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