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
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
- 是
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
Kristen Kelly
Professor
University of California, Irvine
研究点 (2)
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