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临床试验/NCT01176448
NCT01176448已完成不适用

A Comparison Evaluation of Fractional Laser Therapy and Dermabrasion for Scar Revision

University of Minnesota2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2010年4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
6
试验地点
2
主要终点
Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing

研究概览

简要总结

Dermabrasion has been the historical standard used for resurfacing scars on the skin. Recently, fractionated laser therapy has been FDA approved for scar resurfacing. This study intends to compare dermabrasion versus fractionated laser therapy for scar resurfacing.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Post-surgical or post traumatic scar on face or scalp.
  • Age 18 or older
  • Able to read and comprehend English
  • Willing to follow treatment schedule and post treatment care requirements
  • Signed the informed consent form
  • Fitzpatrick skin type I-III

排除标准

  • known photosensitivity
  • Taken any medications known to induce photosensitivity in previous three months
  • Taken Accutane within past 12 months
  • Pregnant or nursing
  • Currently on topical or oral antibiotics
  • Immunocompromised status
  • Skin type IV or greater

研究组 & 干预措施

Fractionated laser

Experimental

This Arm is the section of scar that will be treated with Fractionated Laser

干预措施: Fractionated laser (Device)

Dermabrasion

Active Comparator

Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.

干预措施: Dermabrasion (Device)

结局指标

主要结局

Safey Data Score Based on Ordinal Ratings of Erythema, Edema, Bleeding, Eschar After Resurfacing

时间窗: Day 0, Week1, Month 1

Erythema, edema, bleeding, and eschar after resurfacing were used as indicators of safety. Each was judged based on a 4 point ordinal scale 0=absent, 1=mild, 2=moderate, 3=severe.

次要结局

  • Visual Analog Scale for Assessing Scar Improvement.(3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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