NCT02130609已完成不适用
Skintel Integration Study for Use With the Elite+ Laser System
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index
研究概览
简要总结
The objective of this study is to improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index (MI) (MI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •18 years and older
- •Able to read, understand, and sign the Informed Consent Form
- •Willing and able to comply with all study requirements
排除标准
- •Hypersensitivity to light in the near infrared wavelength region
- •Sun-damaged skin (treatment contraindicated with Alex laser only)
- •Unprotected sun exposure (for Alex laser within four weeks of treatment; for
- •Nd:YAG laser within one week of treatment), including the use of tanning beds or
- •tanning products, such as creams, lotions and sprays
- •Take medication which is known to increase sensitivity to sunlight
- •Seizure disorders triggered by light
- •Take anticoagulants
- •Take or have taken oral isotretinoin, such as Accutane®, within the last six months
- •Take medication that alters the wound-healing response
- •History of healing problems or history of keloid formation
- •Active localized or systemic infection, or an open wound in area being treated
- •Significant systemic illness or an illness localized in area being treated
- •History of skin cancer or suspicious lesions
- •Have received or are receiving or gold therapy
- •Pregnancy, planning on becoming pregnant or have been pregnant recently
研究组 & 干预措施
Skintel
Experimental
干预措施: Skintel (Device)
结局指标
主要结局
improve the treatment guidelines for the Elite+ by determining the maximum safe settings for skin and correlate them to measurement of Melanin Index
时间窗: 9 months
次要结局
未报告次要终点
研究者
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