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临床试验/NCT04834817
NCT04834817已完成不适用

The Effect of Combined Red and Near Infrared Light-emitting Diode (LED) Therapy on Tissue Regeneration Post Laser Treatment

University of California, Irvine2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Days to Healing

研究概览

简要总结

The purpose of this study is to evaluate the effect of light therapy on wound healing after laser treatment.

详细描述

This study sets out to evaluate the effect of a combination of near infrared (830 nm) red (633 nm) and blue (465nm) light-emitting diode (LED) therapy on wound healing after laser application.

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

入选标准

  • Adults aged 18 years or older with no active cutaneous disease on bilateral ventral biceps, close to the axilla.
  • Subjects shall have given written informed consent for both the LED therapy and for clinical photography.

排除标准

  • Patients will be excluded if any of the exclusion criteria applies
  • Subjects refuse to give informed consent for either the phototherapy or the clinical photography.
  • Subjects have previous photosensitivity problems (solar urticaria, etc.).
  • Subjects are taking any systemic drug or applying any topical drug with known photosensitizing properties.
  • Subjects taking any systemic drug with known immunosuppressant properties.
  • Subjects applying any medications to the research site (inner biceps, close to the axilla).
  • Subjects have medical or psychosocial conditions associated with a risk of poor protocol compliance.
  • Subjects are smokers or have smoked within the last 30 days prior to the trial.
  • Subjects have epilepsy or a history of seizures
  • Subjects currently taking cortisone injections or any other kind of steroid injections(s)
  • Subjects with known cancer tumor in the treatment area or metastasis

结局指标

主要结局

Days to Healing

时间窗: Assessed from Day 0 to Day 55, up to 56 days

The primary endpoint of this study is time and days to complete healing of the treatment sites. Clinical grading shall be by blinded assessment.

次要结局

  • Pain Level(Assessed from Day 0 to Day 13, up to 14 days)

研究者

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

Kristen Kelly

Professor

University of California, Irvine

研究点 (2)

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