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临床试验/NCT02798016
NCT02798016已完成不适用

Treatment of Atrophic Acne Scars With Platelet-Rich Plasma Alone or in Combination With Skin Needling: A Randomized Controlled Trial

Damascus University2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2015年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Change in Scar Appearance

研究概览

简要总结

Investigators will collect blood specimens from the participating patients and then blood samples will be centrifuged in order to collect platelet-rich plasma which is going to be injected in the atrophic acne scars. A split-face design is going to used in this randomized controlled trial. In the control side of the face, micro-needling to the skin will occur using a specific tool (Dermapen).

详细描述

Atrophic acne scar is a common problem with a challenging treatment. Platelet-rich plasma (PRP) is an autologous preparation of platelets in concentrated plasma that may be beneficial in the treatment of atrophic acne scars by promoting collagen deposition.

Skin needling is a technique that uses a sterile micro needles to puncture the skin and release growth factors. The combination of skin needling and PRP could enhance the efficacy of both modalities.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Atrophic acne scars on both sides of the face

排除标准

  • patients with active acne, herpes labialis, or bacterial infection; warts on the face, actinic keratosis, or skin cancer
  • systemic retinoids intake in the previous 6 months,
  • diabetes, pregnancy, history of keloidal scarring; or patients with severe systemic illness or malignancy
  • patients on anticoagulant therapy or aspirin or have a coagulation issue,
  • patients with hemoglobin less than 10g\dl or platelet less than 105 micron\l
  • any previous procedures for acne scar within the last 6 months

研究组 & 干预措施

Platelet-Rich Plasma with micro-needling

Active Comparator

The scars will be dealt with using micro-needling as well as injecting Platelet-Rich Plasma

干预措施: Platelet-Rich Plasma (Procedure)

Platelet-Rich Plasma alone

Experimental

The scars will be injected with Platelet-Rich Plasma alone.

干预措施: Platelet-Rich Plasma (Procedure)

Platelet-Rich Plasma with micro-needling

Active Comparator

The scars will be dealt with using micro-needling as well as injecting Platelet-Rich Plasma

干预措施: Micro-needling (Procedure)

结局指标

主要结局

Change in Scar Appearance

时间窗: Scar Appearance will be assessed at: T1; one day (wihtin 24 hours) before the application of the intervention(s); and T2: after three months of applying the intervention(s).

次要结局

  • Patients' Satisfaction(This is going to be assessed six months following the application of the intervention and the active comparator)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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