755nm Alex Laser for Treatment of Pigmented and Vascular Lesions and Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Clearance Based on Photographic Scale
研究概览
简要总结
Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between 18 and 85 years of age.
- •Subjects with Fitzpatrick skin types I to VI.
- •Subjects who have unwanted pigmented lesions, vascular lesions, striae and/or hypertrophic or atrophic scars
- •Subject who are willing to consent to participate in the study.
排除标准
- •Subject who will not be photographed or who will not cooperate with the post treatment care and follow up schedule
- •Hypersensitive to light exposure.
- •Active localized or systemic infections.
- •Taking medication for which sunlight is a contraindication.
- •History of squamous cell carcinoma or melanoma.
- •History of keloid scarring.
- •Use of oral isotretinoin (Accutane®) within 12 months of initial treatment or during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
- •Prior treatment with laser or other devices in treatment area within 3 months
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- •Subjects who are pregnant, have been pregnant within the last 3 months, are currently breast feeding or are planning a pregnancy within the study period.
- •Subjects that the physician determines ineligible based on standard of care treatment.
研究组 & 干预措施
Laser Treatment
干预措施: 755nm Alex laser (Device)
结局指标
主要结局
Clearance Based on Photographic Scale
时间窗: 3 months post last treatment
This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
Clearance Based on Photographic Scale
时间窗: 1 months post last treatment
This scale ranges from 0 to 3, where 0 is 0-25% clearance, 1 is 26-50% clearance, 2 is 51-75% clearance and 3 is 76-100% clearance. The baseline picture was compared to a photograph taken at the follow up visit. The number of patients that fell into each category was recorded.
次要结局
未报告次要终点