Treatment of Surgical Scar With 2940 nm Erbium: Yttrium Aluminum Garnet (YAG) Laser Examined Under Optical Coherence Tomography
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- POSAS Scar Assessment
研究概览
简要总结
The purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Adults age 18 years or older
- •Patients should have Fitzpatrick skin types of I-IV
- •Patients should have mild to severe post-surgical scarring located on head and neck
- •Scar lengths of at least 3 cm.
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
- •Scar size less than 3 cm in length
- •Pregnant or lactating females
- •Fitzpatrick skin type of V-VI
- •Scleroderma
- •Photosensitivity
- •Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months.
结局指标
主要结局
POSAS Scar Assessment
时间窗: Up to 13 weeks
Patient and Observer Scar Assessment Scale (POSAS) has a total score ranging from 6 (normal skin) to 60 (severely scarred skin).
Surgical Scar Blood Flow
时间窗: Up to 13 weeks
As measured using optical coherence tomography
Surgical Scar Collagen Content
时间窗: Up to 13 weeks
As measured using optical coherence tomography
Surgical Scar Skin Roughness
时间窗: Up to 13 weeks
As measured using optical coherence tomography
Surgical Scar Epidermal Thickness
时间窗: Up to 13 weeks
As measured using optical coherence tomography
次要结局
- Incidence of Adverse Events(Up to 13 weeks)
研究者
Keyvan Nouri
Professor
University of Miami