Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale
研究概览
简要总结
Evaluation of the PicoWay™ Laser System With 730nm and Resolve™ Fusion Handpieces for Treatment of Benign Pigmented Lesions and Wrinkles.
详细描述
Subjects will receive up to 4 study treatments with the PicoWay™ 730 nm laser wavelength, PicoWay™1064nm fractional handpiece and/or PicoWay™ 1064nm fractional handpiece for treatment of benign pigmented lesions or wrinkles. Subjects will return for three follow-up visit evaluations 1-month, 2-months and 3-months post final study treatment. Primary efficacy assessed by masked photographic evaluation. Optional biopsy collection for histological analysis of laser tissue effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing to provide signed informed consent
- •Adults age 21 to 80
- •Fitzpatrick Skin Type (FST) I to VI
- •Presence of benign pigmented Lesions assessed at baseline as Pigment Severity Score (PSS) of "2" or higher and/or wrinkles assessed at baseline as Fitzpatrick Wrinkle Score (FWS) of "2" or higher
- •Willing to allow photographs and/or video to be taken of treated areas for the purposes of this research study
- •Willing to abstain from any other procedures for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including surgery, light, laser, ultrasound or radiofrequency treatments
- •Willing to abstain from use of prescription cosmetic products for treatment of benign pigmented lesions or wrinkles in the laser treatment areas for the duration of the study including injections of neurotoxins or dermal fillers, skin lightening creams, and wrinkle creams
- •Willingness to adhere to study treatment and follow-up visit schedules
排除标准
- •Pregnant, planning pregnancy or breast feeding
- •Allergy to topical or injectable lidocaine or similar medications
- •Allergy to topical steroid or similar medications
- •Unprotected sun exposure in the six weeks prior to enrollment, or active tan in the laser treatment area
- •History of melanoma in the intended treatment area
- •History of keloid or hypertrophic scar formation
- •Use of topical or systemic retinoid therapy during the past six (6) months
- •Use of neurotoxins in the intended treatment area within the past three (3) months or throughout the duration of the study
- •Use of dermal fillers in the intended treatment area within the last six (6) months or throughout the duration of the study
- •Severe immunosuppression resulting from medications and/or a medical condition that could impair healing after treatment.
- •Open wound or infection in the intended treatment area
- •History of light induced seizure disorders
- •Dermatologic and/or cosmetic procedures in the intended treatment area(s) during the past six months
- •The subject is not suitable, in the opinion of the clinician, for participation in the study due to medical or other reasons that could compromise the study integrity or subject safety
研究组 & 干预措施
Picoway™ 532nm fractional handpiece
Subjects will receive up to four study treatments with the PicoWay™ 532nm fractional handpiece
干预措施: PicoWay™ 730nm wavelength (Device)
PicoWay™ 730nm wavelength
PicoWay™ 730nm wavelength. Subjects will receive up to four study treatments with the PicoWay™ 730nm wavelength.
干预措施: PicoWay™ 532nm fractional handpiece (Device)
PicoWay ™1064nm fractional handpiece
Subjects will receive up to four study treatments with the PicoWay™ 1064nm fractional handpiece
干预措施: PicoWay™ 1064nm fractional handpiece (Device)
结局指标
主要结局
Change in Wrinkles From Baseline to 12 Weeks Post-study Treatment Assessed by Blinded Photographic Evaluation Using 9-Point Fitzpatrick Wrinkle Scale
时间窗: Baseline to 12-week follow-Up Visit
9-Point Fitzpatrick Wrinkle Scale (FWS) 1=Fine Wrinkles to 9=Deep Wrinkles 1-3 Mild (fine textural changes with subtly accentuated skin lines) 4-6 Moderate (distinct papular elastosis \[individual papules with yellow translucency under direct lighting\] and dyschromia) 7-9 Severe (multipapular and confluent elastosis \[thickened yellow and pallid\] approaching or consistent with cutis rhomboidalis)
Change in Benign Pigmented Lesions From Baseline to 12 Weeks Post-study Treatment in Pigment Clearance Score (PCS) as Determined by Blinded Evaluators From Clinical Photography
时间窗: Baseline to 12-week follow-Up Visit
5-Point Pigment Clearance Score (Score, Clearance %, Description) 1. = 0-24% = Poor Response 2. = 25-49% = Fair Response 3. = 50-74% = Good Response 4. = 75-94% = Excellent Response 5. = \>95% = CompleteResponse
次要结局
- Change in Subject Satisfaction Mean of Scores From 2nd Treatment Visit to Last Visit by Treatment Group Using a 5-Point Likert-type Rating Scale(Pre-Treatment 2 at Week 6, Pre-Treatment 3 at Week 12, Pre-Treatment 4 at Week 18, 1 Month Follow-Up at Week 22, 2 Month Follow-Up at Week 26, and 3 Month Follow-Up at Week 30)