Multi-Center Study to Compare the Safety and Efficacy of Clearance of Surgical Scars With the Pulse Dye Laser in Combination With a CO2 Laser in a Split Scar Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline
研究概览
简要总结
Prospective, randomized, split lesion treatment with 4 study Arms to evaluate safety and efficacy of combined treatment for minimizing of surgical scars, including post Moh's surgery.
详细描述
Prospective, Randomized, Split lesion treatment with 4 study Arms: 1) treatment with pulsed dye laser (PDL) only, 2) treatment with CO2 laser only, 3) PDL and CO2 laser combined treatment, and 4) split scar combined lasers with an additional single CO2 laser treatment immediately post-surgery vs. no treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- 是
入选标准
- •Comprehension of, and willingness to sign, the Informed Consent Form.
- •Have a planned a surgical procedure, which is expected to result in a least one linear surgical scar of at least 3.0 cm.
- •Be a healthy male or female of at least 18 years old.
- •Fitzpatrick skin type I-V.
- •Willingness to follow the treatment and follow-up schedule and the post-treatment care instructions.
- •Non pregnant and/or breast feeding, if applicable.
- •Willingness to provide a brief medical history including disclosure of any prescribed or over-the-counter medications taken within the past 6 months.
- •Agree to follow and undergo all study-related procedures.
- •Use of daily use of sunblock SPF 30 or higher for duration of the study.
排除标准
- •Pregnant and/or breastfeeding.
- •Fitzpatrick skin type VI.
- •Prior treatment for the surgical scar to be treated in this study.
- •Having a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treated area, unless treatment is conducted following a prophylactic regimen.
- •Use of Isotretinoin or other systemic retinoids within the past 6 months.
- •Use of topical retinoids or therapeutic topicals in the treatment area in past 2 months.
- •Use of medications that induce photosensitivity on the 595 and 10,600 nm wavelength ranges.
- •Suffering from current or history of significant skin conditions in the treated area or inflammatory skin conditions.
- •History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications.
- •Having any uncontrolled disease or disorder or one which per the investigator's judgment might make it unsafe for the subject to participate in this study.
- •Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning and sun exposure for the duration of the study.
- •Participation in another investigational device or investigational drug study within 30 days prior to enrollment, as per the investigator's clinical judgment.
- •As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.
研究组 & 干预措施
Pulsed Dye Laser treatment
Pulsed Dye Laser treatment after suture removal (3 sessions)
干预措施: Pulsed dye laser treatment (Device)
CO2 laser treatment
CO2 laser (3 treatment sessions) after suture removal
干预措施: CO2 laser treatment (Device)
Combined PDL and CO2 Laser treatment
Combined PDL and CO2 Laser resurfacing (3 treatment sessions) after suture removal
干预措施: Combined PDL and CO2 laser treatment (Device)
Split PDL and CO2 Laser treatment
Half of the scar was not treated and served as a control, while the other half was treated with CO2 ablative fractional resurfacing immediately after surgery, in addition to the three combined PDL and CO2 treatment sessions after suture removal
干预措施: Split PDL and CO2 Laser treatment (Device)
结局指标
主要结局
Improvement in Global Evaluation Response (GER) scale for 4 study arms compared to baseline
时间窗: Baseline, 3 months after final treatment
Blinded review of 7-point Global Evaluation Response (GER) scale
次要结局
- Improvement in Vancouver Scar Scale (VSS) scale for 4 study arms compared to baseline(Baseline, 3 months after final treatment)