NCT03969485已完成不适用
Non-Randomized, Open-label, Blinded Evaluator Study Characterizing Effectiveness of Hybrid Fractional Laser for the Treatment of Off Face Body Skin Quality
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sciton
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Photography
研究概览
简要总结
To demonstrate effectiveness of hybrid fractional laser for the treatment of poor skin quality on the decolletage, back of the hands and lower legs
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male/female subjects between 40 to 65 years of age inclusive
- •Fitzpatrick skin type I-III
- •Non-smokers or have not smoked (including vaping) within the past 14 days from the screening visit
- •Has poor skin texture
- •Has mild thin skin
- •Has some level of dyschromia on the treatment area as assessed by the Investigator
- •Can read, understand and sign informed consent form (English only)
- •Has indicated willingness to participate in the study by signing an informed consent form
- •Agrees to adhere to the treatment and follow-up schedule and post treatment care instructions
排除标准
- •Fitzpatrick skin type IV-VI
- •Has tanned within the past 30 days or is unable or unlikely to refrain from tanning, including the use of tanning booths, tanning spray or cream
- •Has tattoos, dysplastic nevi on the treatment area
- •Is pregnant and/or lactating
- •History or current photosensitivity
- •History or current use of medication with photosensitizing properties within past 6 months
- •History or current of chronic reoccurring skin disease or disorder affecting treatment area
- •History or current cancer of any type
- •Has signs of actinic bronzing
- •Has open lacerations, and abrasions on the treatment area
- •History of keloid formation, or hypertrophic scar formation, or poor wound healing
- •History of bleeding disorder, or is currently taking anticoagulation medications
- •Has significant concurrent illnesses (controlled or uncontrolled), such as diabetes, lupus, epilepsy, or cardiac disorders, which might be aggravated as a result of treatment
- •Has participated in any clinical trial involving an investigational drug, device or cosmetic product or procedure within the past 30 days
- •The investigator feels that for any reason the subject is not eligible to participate in the study
结局指标
主要结局
Photography
时间窗: 3 months
Evaluate improvement in photography using Physicians Global Assessment Scale (0-4) where 0 is no change and 4 is very significant improvement.
次要结局
未报告次要终点
研究者
研究点 (2)
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