Evaluation of Non-Ablative Laser for Treatment of Direct Brow Lift Scars
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Relative Improvement
研究概览
简要总结
The purpose of this study is to determine the efficacy of the 1064nm Neodymium yttrium aluminum garnet (Nd:YAG) laser (Laser Genesis, Cutera TM) in the treatment of surgical scar after direct brow lift.
详细描述
Patients who undergo a direct brow lift may participate in this study. Participants will receive laser treatment on one of the two surgical wounds (side of treatment will be chosen randomly by an independent source). Treatment parameters will be 500 spots and 10-14 megajoules (mJ) depending on skin type. The opposite side brow scar will not be treated until 1 month after the study is completed (if the patient elects to treat the contralateral brow after study completion this will be done at no charge to the patient). This treatment will be given at 2-4 week intervals for 6 treatments. Photographs will be taken at each visit, and they will be assessed based on different parameters by an examiner, as well as judged by the patient based on overall appearance.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Undergoing or have undergone direct brow lift
排除标准
- •under 18 years old
- •history of photodermatoses
- •receiving systemic isotretinoin within the preceding 6 months
- •undergoing other scar treatment in the brow area
- •pregnant patients
- •history of adverse outcomes related to non-ablative laser
研究组 & 干预措施
Laser Treatment Side
Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was "too hot" as an additional safeguard against epidermal damage.
干预措施: Laser treatment (Device)
Control side
Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
结局指标
主要结局
Relative Improvement
时间窗: 1 month after final treatment
Which scar, overall, appears to have improved more from initial to final visit, as rated by blinded examiner of photographs
次要结局
- Overall Appearance(10 minutes before first treatment and at the final visit)
- Hair Loss(within 1 hour after final treatment)
研究者
Sara T. Wester
Ophthalmologist
University of Miami