NCT05123508撤回不适用
Treatment of Surgical Scars Following Breast Lifts/Reductions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Sciton
- 试验地点
- 4
- 主要终点
- Improvement in surgical scars
研究概览
简要总结
Laser and light treatment for surgical scars following breast lifts/reductions
详细描述
The purpose of the study is to demonstrate effectiveness of laser and light therapy for the treatment of surgical scars following breast lifts/reductions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female subjects between 25 to 60 years of age inclusive
- •Fitzpatrick skin type I-IV
- •Subjects with post-surgical breast lift/reduction scar
- •A maximum of 8-10 weeks since surgery
- •Healed surgery wound in the treatment area
- •Willing to have photographs taken of the treatment area
- •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 V-VI
- •Breast reconstruction with radiation treatment
- •Is pregnant and/or lactating
- •Has tattoos, dysplastic nevi in the treatment area
- •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 hormonal disorder
- •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
Improvement in surgical scars
时间窗: 3 months
Degree of improvement in scars using photographs assessed via modified Vancouver scar scale
次要结局
- Overall improvement(3 months)
- Overall Improvement(3 months)
研究者
研究点 (4)
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