NCT02754479已完成不适用
A Clinical Evaluation of the Treatment of Spider Veins on the Ankles Using a Dual Wavelength Laser Emitting 532 nm and 1064 nm Laser Energy
Cutera Inc.2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2016年6月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles
研究概览
简要总结
To evaluate the safety and effectiveness of the Excel V system for the treatment of lower extremity spider veins on the ankles.
详细描述
The purpose of this study is to evaluate the real-world effectiveness of the 532 nm and 1064 nm Nd:YAG lasers within the Cutera Excel V system for the treatment of lower extremity spider veins, specifically on the ankles, within a clinic setting.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, 20 to 75 years of age (inclusive).
- •Fitzpatrick Skin Type I - III.
- •Having spider veins on at least 1 ankle measuring 2.0mm or less in diameter, linear or branching, and red, pink, blue and/or purple in color, as assessed by the investigator.
- •Having spider veins on the ankle that are appropriate for laser treatment, as assessed by the investigator.
- •Subject must be able to read, understand and sign the Informed Consent Form.
- •Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- •Wiling to have limited sun exposure for the duration of the study, including the follow-up period.
- •Willingness to have digital photographs taken of ankle spider veins and agree to use of photographs for presentation, educational or marketing purposes.
- •Agree not to undergo any other procedure for the treatment of ankle spider veins during the study.
排除标准
- •Fitzpatrick Skin Type IV - VI.
- •Having an infection, dermatitis or a rash in the treatment area.
- •Having significant varicosities or perforator veins.
- •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- •Systemic use of isotretinoin (Accutane®) within 6 months of study participation.
- •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study.
- •In the opinion of the investigator, any physical or mental condition which might make it unsafe for the subject to participate in this study or which requires systemic therapy that could interfere with this research study.
结局指标
主要结局
Physician Global Assessment of Improvement in Treated Spider Veins on the Ankles
时间窗: Four weeks post final laser treatment.
Improvement in treated ankle spider veins at 4 weeks post final laser treatment (compared to baseline) as assessed by a blinded evaluators Physician Global Assessment Scale score (Min=0; 4= Max). Higher Score Indicates Better Outcome.
次要结局
- Subject Satisfaction With Improvement in Treated Spider Veins on the Ankles(Four weeks post final laser treatment)
研究者
研究点 (2)
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