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临床试验/NCT05511493
NCT05511493Unknown不适用

Efficacy of Platelet-rich Plasma With Fractional Erbium-YAG Laser Versus With Microneedling in Localized Stable Vitiligo

South Valley University0 个研究点目标入组 40 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
percentage of skin repigmentation of localized stable vitiligo

研究概览

简要总结

The aims of this study are to:- Compare the effect of fractional Erbium: YAG laser assisted delivery of platelet- rich plasma versus microneedling with platelet-rich plasma in the induction of skin repigmentation in localized stable vitiligo patients.

详细描述

Vitiligo is a depigmentation disease characterised by epidermal melanocyte death and melanin loss. It affects less than 0.1% to greater than 8% of the world's population. It is caused by a dynamic interplay between genetic and environmental risks that initiates an autoimmune attack on melanocytes in the skin. There are some treatment modalities, such as topical steroids, topical calcineurin inhibitors, excimer laser, narrowband-ultraviolet B therapy (NB-UVB), vitamin D,and non-cultured epidermal cell suspension (NCES).

One of the representative autogenous regenerative biomaterials is platelet-rich plasma (PRP) which contains moderate to high concentrations of platelets together with multiple biomolecules and moderate concentrations of leucocytes. Activated platelets can release autogenous growth factors that may initiate a signalling cascades and lead to numerous intracellular changes, promoting the proliferation, migration, and differentiation of stem cells and regulating local inflammation and immune responses.

Laser- assisted drug delivery (LADD) functions by creating focused zones of selective epidermal damage thereby rendering the dermis more accessible to topical medication.

Multiple lasers have been applied for the purpose of LADD, including ablative fractional carbon dioxide (CO2) and erbium-doped yttrium-aluminum-garnet (Er: YAG) lasers.

Microneedling (Mn) is a minimally invasive process in which many tiny needles penetrate the skin. It augments transdermal drug delivery (TDD) through the creation of pores in the stratum corneum. This technique is also believed to induce pigmentation by physically moving melanocytes with the needles into the vitiligo areas from the pigmented areas, so that they may serve as reservoirs for melanogenesis, also it induces microinflammation which stimulates the migration of keratinocytes and melanocytes that induces the release of cytokines and growth factors stimulating melanocytes at the periphery of vitiligo patches and their migration from pigmented to unpigmented areas.

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

入选标准

  • Patients of both sexes with stable localized vitiligo: stable patches (should not have any increase or decrease in size or pigmentation for at least 3 months) .
  • Age between 10 - 60 years

排除标准

  • Acute or chronic infections. 2) Koebner phenomenon. 3) Contraindications to PRP injections:
  • Patients with blood or platelet abnormalities.
  • Patients taking anti-platelet drugs or anticoagulants.
  • Patients with a history of altered or abnormal fibroblast function, such as collagen diseases or myelofibrosis.
  • We also excluded pregnant or lactating women. 5) All patients included had not received any local or systemic medication for at least 2 months before the study.

结局指标

主要结局

percentage of skin repigmentation of localized stable vitiligo

时间窗: six month

according to Physician's Global Assessment \[PGA\] G4 (excellent: \>75% repigmentation) G3 (very good: 50%-75% repigmentation) G2 (good: 25%-50% repigmentation) G1 (satisfactory: \<25% repigmentation) G0 (poor: no repigmentation) The start of color and textural changes of skin will be examined every month. Assessment of pattern of repigmentation as marginal, perifollicular, diffuse and combined .

次要结局

  • Response to treatment(six month)

研究者

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

aya marouf hameed aref

principal investigator

South Valley University

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