Safety and Efficacy Evaluation of Fractional Erbium Treatment
试验速览
- 阶段
- 不适用
- 入组人数
- 151
- 试验地点
- 10
- 主要终点
- Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.
研究概览
简要总结
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
详细描述
The purpose of this investigation is to evaluate erbium laser devices for dermatological cosmetic procedures.
Each subject will undergo up to 6 treatment sessions, with scheduled time-points for follow-up visits. The Investigator determines the number of treatments. Subjects may be treated on there face, neck, chest or other body areas as deemed appropriate by the Investigator. At each visit, the treated areas will be clinically evaluated for side effects and will also have photographs taken of their treated areas. Subjects will be asked to complete a self-assessment questionnaire at different time points throughout their study participation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male and female Adults (18 years or older).
- •Subjects who can read, understand, and sign the Informed Consent Form.
- •Subjects willing and able to comply with all study requirements.
排除标准
- •Subjects with active localized or systemic infections.
- •Immunocompromised subjects.
- •Subjects with coagulation disorder.
- •History of skin photo sensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
- •Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
- •In the opinion of the trained clinician, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits.
- •Use of Accutane® within the past 6 months.
- •Subjects with a history of radiation therapy to the treatment area.
- •Subjects with any skin pathology or condition that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments.
- •Subjects have undergone dermatological procedures (e.g., laser or light treatments) for the treatment of wrinkles, skin resurfacing, or skin rejuvenation in the treatment area within 1 year of study participation.
结局指标
主要结局
Number of Participants That Scored Above a One Category (Mild) Improvement Using the Fitzpatrick Wrinkle Scale.
时间窗: participants at three months
To assess wrinkle improvement, 3 blinded evaluators use the validated Fitzpatrick Wrinkle Scale (FWS), a 0 to 9 (0=no wrinkles, 9=severe wrinkles) point scale to score the degree of wrinkles, fine lines, and the severity of skin elastosis. Evaluators assign a FWS score to pre-treatment and post-treatment photographs. The difference between the two scores is the amount (i.e., category) of wrinkle improvement. An improvement of one category means a mild improvement in wrinkle reduction.
次要结局
- Number of Participants That Have Reduction in Pigmented Lesions and Dyschromia.(participants at three months)