NCT02755467已完成不适用
A Clinical Evaluation of the Treatment of Spider Angioma Using a Dual Wavelength Laser Emitting 532 nm Laser Energy
Cutera Inc.2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年5月26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
- 22
- 试验地点
- 2
- 主要终点
- Physician's Global Assessment Scale for Improvement of Spider Angioma
研究概览
简要总结
To evaluate the safety and effectiveness of the laser treatment for the treatment of spider angiomas.
详细描述
The purpose of this study is to evaluate the safety and efficacy of the 532 nm KTP laser within the Cutera Excel V system for the treatment of spider angiomas.
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
- 5 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females, 5 to 65 years of age (inclusive).
- •Fitzpatrick Skin Types I-IV
- •Subject must be able to read, understand and sign the Informed Consent Form.
- •If subject is a minor (<18 years old in Illinois), Assent must be obtained from the subject and a Parental Consent Form must be signed by the parents or legal guardian.
- •Subject must be willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions.
- •Willing to have limited sun exposure for the duration of the study, including the follow-up period.
- •Willingness to have digital photographs taken of their spider angioma(s) and agree to use of photographs for presentation, educational or marketing purposes
- •Agree not to undergo any other procedure for the treatment of spider angioma during the study.
排除标准
- •History of pigmentary disorders, particularly tendency for hyper- or hypo-pigmentation.
- •Having a known anti-coagulative condition or taking anticoagulation medications, including aspirin.
- •History of seizure disorders due to light.
- •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.
- •Participation in a study of another device or drug within 3 months prior to enrollment or 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's Global Assessment Scale for Improvement of Spider Angioma
时间窗: Four weeks post laser treatment.
Assessment of Baseline vs. 4 weeks post-final treatment for improvement of spider angiomas using the Physician's Global Assessment scale. High scores indicate better outcomes: 0. None 1. Mild 2. Moderate 3. Significant 4. Very Significant 5. Complete Removal
次要结局
未报告次要终点
研究者
研究点 (2)
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