The Effect of Combined Treatment of PDL and Fractional Photothermolysis on the Cosmetic Appearance of Postsurgical Scars
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change in score of Patient and Observer Scar Assessment Scale (POSAS)
研究概览
简要总结
This is a two part study to evaluate the efficacy of early combined PDL (pulsed dye laser) and fractional photothermolysis in the cosmetic improvement of post surgical scars.All subjects will be offered at the time of the dermatologic procedure, an option to treat the post surgical scars with early combined PDL and fractional photothermolysis.
Part A is a non-randomized study design and subjects will have the choice of whether or not they will receive treatment. In part B, subjects will be randomized in a 2:1 treatment vs. control design.
The experimental group will have a total of 6 visits: 1 standard of care suture removal visit, 3 treatment visits and 2 follow up visits. The control group will have 3 visits: 1 standard of care suture removal visit and 2 follow up visits.
Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.
This study is a pilot study designed to determine feasibility of this procedure.
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
- •Males or females ≥ 18 years old
- •Fitzpatrick skin types I-VI
- •Subjects are in good health as judged by the investigator.
- •Subjects who have received dermatologic surgery procedure of the trunk or extremities closed with complex primary closure with subcuticular running suture removed at 2-3 weeks.
- •Subjects applying topical retinoids, must discontinue one week prior to treatment.
- •Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
排除标准
- •History of recurrent facial or labial herpes simplex infection
- •Subjects applying topical retinoids, must discontinue one week prior to treatment.
- •Subjects with a history of hypertrophic scars or keloids
- •Pregnant or breast feeding
- •Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- •Subjects who are unable to understand the protocol or give informed consent.
- •Subjects who in the opinion of the investigator are likely to have exaggerated scarring with laser treatments.
研究组 & 干预措施
PDL (Pulsed Dye Laser) and Fractional Photothermolysis
干预措施: PDL (Pulsed Dye Laser) (Device)
PDL (Pulsed Dye Laser) and Fractional Photothermolysis
干预措施: Fractional Photothermolysis Laser (Device)
Control
结局指标
主要结局
Change in score of Patient and Observer Scar Assessment Scale (POSAS)
时间窗: Baseline and 6 Months
The POSAS is a series of questions about the scar with a scale from 1 to 10 with 1 as "not at all" or "normal skin" and 10 as "very much so" or "very different".
次要结局
未报告次要终点
研究者
Murad Alam
Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery
Northwestern University