Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Photographic Evaluation of Scar Clearance
研究概览
简要总结
Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is a healthy male or female between 18 and 85 years old.
- •Has unwanted scars (including atrophic, hypertrophic, hyper or hypo pigmented, erythematous )and wishes to undergo laser treatments to remove or improve them.
- •Is willing to consent to participate in the study.
- •Is willing to comply with all requirements of the study including being photographed, following post treatment care and attending all treatment and follow up visits
排除标准
- •Is hypersensitive to light exposure.
- •Has active localized or systemic infection.
- •Is taking medication(s) for which sunlight is a contraindication.
- •Has a history of squamous cell carcinoma or melanoma.
- •Has a history of keloid scarring.
- •Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment.
- •Has a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications.
- •Is female and pregnant, has been pregnant within the last 3 months, is currently breast feeding or planning a pregnancy during the study period.
- •Is allergic to lidocaine, tetracaine or Xylocaine with epinephrine.
- •Has any other reason determined by the physician to be ineligible to participate in the study.
研究组 & 干预措施
755nm Alexandrite Laser
755nm Alexandrite Laser
干预措施: 755nm Alexandrite Laser (Device)
结局指标
主要结局
Photographic Evaluation of Scar Clearance
时间窗: 3 Months Post Last Treatment
The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement.
Photographic Evaluation of Scar Clearance
时间窗: 1 Month Post Last Treatment
The échelle d'évaluation clinique des cicatrices d'acné (ECCA) Grading scale was used to evaluate the photographs, using 2D and 3D photography, where the scale ranges from 0 to 4. 0 represents 0% improvement/worse, 1 is 1-25% improvement, 2 is 26-50% improvement, 3 is 51-74% improvement, and 4 is \>75% improvement.
次要结局
未报告次要终点