Treatment of Atrophic Facial Acne Scars With Er: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
- Change in epidermal thickness
研究概览
简要总结
This study is examining the effects of the 2940 nm Er:YAG on atrophic facial acne scars under optical coherence tomography in terms of blood flow, vessel shape, skin roughness, collagen content, and epidermal thickness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients should be 18-90 years of age
- •Patients should have Fitzpatrick skin types of I-III
- •Patients should have at least mild acne
排除标准
- •The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
- •Pregnant or lactating females
- •Fitzpatrick skin type of IV-VI
- •A history of keloids or hypertrophic scars
- •Scleroderma
- •Photosensitivity
- •Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months
- •Subjects with a known history of herpes simplex
研究组 & 干预措施
Laser Treatment
Patients will receive one laser treatment (week 0) with the Erbium YAG laser at a 2940nm wavelength (Alma - Harmony XL Laser) and parameters corresponding with their acne scar severity. They will then return to the clinic 1, 4 and 8 weeks (7, 30, and 56 days + 7 days) after the treatment for their scars to be evaluated under optical coherence tomography.
Laser parameters are as follows:
iPixelEr 2940nm Erbium:YAG Module: mild scars: 7 by 7 (7X7) mm tip, energy 1400-1600 millijoules/P (mJ), pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap moderate scars: 7X7 mm tip, energy 1600-1800 mJ/P, pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap severe scars: 7X7 mm tip, 1800-2000 mJ/P, pulse energy 5 Hz, 2-6 stacks, pulse mode L, 2-3 passes, 10% overlap
干预措施: Alma - Harmony XL Laser (Device)
结局指标
主要结局
Change in epidermal thickness
时间窗: During 8 weeks
Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of epidermal thickness (mm).
Change in collagen content
时间窗: During 8 weeks
OCT will be used to qualitatively measure changes in facial atrophic acne scars in terms of collagen content. Collagen content will be measured in terms of brightness of OCT scan. Areas of skin that contain collagen tend to be brighter (more white in color) whereas areas with less collagen content tend to be darker.
Change in blood flow
时间窗: During 8 weeks
Optical coherence tomography (OCT) will be used to quantitatively measure changes in facial atrophic acne scars in terms of blood flow (proportion of signals with strong dynamic signal (%)/depth (mm)).
Change in skin roughness
时间窗: During 8 weeks
OCT will be used to quantitatively measure changes in facial atrophic acne scars in terms of skin roughness (µm).
次要结局
- The Observer Scar Assessment Scale(During 8 weeks)
- The Patient Scar Assessment Scale(During 8 weeks)
研究者
Keyvan Nouri
Doctor of Medicine
University of Miami