Clinical Assessment of the Performance of a Fractional CO2 Laser System (Fraxel Repair Laser) Intended for Treatment of Perioral Rhytides/Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Change in the lip wrinkles from baseline to 6 month
研究概览
简要总结
Objective 1: To evaluate the effect and histologic (cellular) changes associated with varying energy and density settings of the Fraxel Repair Laser to determine an optimal dose response.
Objective 2: To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.
详细描述
To evaluate the clinical response associated with variable energy and density settings of fraxel laser treatment in the upper lip. Overall assessment of clinical outcome and safety will be based clinic visits and evaluation of pre- and post- procedural photos. The subject's assessment of satisfaction will be characterized using a non-parametric assessment scale at each follow-up period.
This is a multi-site, non-randomized, non-controlled investigator initiated study designed to follow a total of 30 qualified and consenting subjects treated with one Fraxel Repair treatment in the course of clinical practice.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female adults between 18-75 years of age.
- •Subjects who can read, understand, and sign the Informed Consent Form.
- •Subjects willing and able to comply with all study requirements.
- •Fitzpatrick skin type I-IV (Although the systems are cleared for all skin types I- VI, it is recommended to use the Matrix applicators on skin types I- V).
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.
- •Subject has a history of allergy to lidocaine or ester-based local anesthetics.
- •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
Change in the lip wrinkles from baseline to 6 month
时间窗: 6 month
The primary outcome measure of effectiveness will be a paired comparison of baseline to 6 month follow-up ratings for wrinkles using a Merz Aesthetic Lip Line score (0 none 1-4). Safety will be defined as an absence of hypopigmentary changes and by a restoration of hyperpigmentary changes to mild or less at 6 month. Photographs of treated skin at follow-up visits will be compared to baseline to document the healing time course and may be used for blinded scoring evaluations (0-9 scales) of wrinkles, skin texture and color changes. The investigator will grade the epidermal response including side effects and adverse events using the 0 to 10 grading scale.
Change in the lip wrinkles from baseline to 1 month
时间窗: 1 month
The primary outcome measure of effectiveness will be a paired comparison of baseline to 1, 3, and 6 month follow-up ratings for wrinkles using a Merz Aesthetic Lip Line score (0 none 1-4). Safety will be defined as an absence of hypopigmentary changes and by a restoration of hyperpigmentary changes to mild or less at 1 month. Photographs of treated skin at follow-up visits will be compared to baseline to document the healing time course and may be used for blinded scoring evaluations (0-9 scales) of wrinkles, skin texture and color changes. The investigator will grade the epidermal response including side effects and adverse events using the 0 to 10 grading scale.
Change in lip wrinkle from baseline to 3 months
时间窗: 3 month
The primary outcome measure of effectiveness will be a paired comparison of baseline to 3 months ratings for wrinkles using a Merz Aesthetic Lip Line score (0 none 1-4). Safety will be defined as an absence of hypopigmentary changes and by a restoration of hyperpigmentary changes to mild or less at 3 month. Photographs of treated skin at follow-up visits will be compared to baseline to document the healing time course and may be used for blinded scoring evaluations (0-9 scales) of wrinkles, skin texture and color changes. The investigator will grade the epidermal response including side effects and adverse events using the 0 to 10 grading scale.
次要结局
未报告次要终点