NCT02592993Unknown不适用
Clinical Study to Evaluate the Performance of the PicoWayTM Picosecond Fractional Laser for Treatment of Acne Scars
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 53
- 试验地点
- 5
- 主要终点
- Efficacy of the PicoWayTM treatment
研究概览
简要总结
Open-label, prospective study. Up to 60 healthy adult volunteers seeking facial acne scars treatment, males or females of 18 to 75 years of age, from up to 3 investigational sites.
详细描述
Subjects in this study will receive up to six (6) treatments in 3-8 weeks interval, with the PicoWayTM device-fractional handpiece 532nm and/or 1064nm according to the study protocol. Subjects will be followed by phone 7 days post first treatment by study staff, and will return for two follow-up (FU) visits at the clinic at: 6 weeks and 12 weeks following the last treatment.
Methodology described in the protocol to evaluate efficacy and safety of treatments will be carried out at each visit at the clinic.
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 female and male subjects between 18 to 75 years of age
- •Has Fitzpatrick skin type I-VI
- •Subjects seeking treatment for acne scars and wishes to undergo laser treatments for improvement
- •Have bilateral moderate to severe facial acne scars
- •Willing to receive the proposed PicoWayTM fractional treatments and comply with all study (protocol) requirements
- •Willing to have photographs and images taken of the treated areas to be used in evaluations, publications and presentations (subject identity will be masked)
- •For female subjects: not pregnant or lactating and is either post-menopausal, surgically sterilized, or using a medically acceptable form of birth control at least 3 months prior to enrollment (i.e., oral contraceptives, contraceptive implant, barrier methods with spermicide or abstinence)
- •Informed consent process is completed and subject consent is signed
排除标准
- •Pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding
- •Hypersensitivity to light exposure
- •Active sun tan in facial area
- •Suffering from significant skin conditions in the treated areas or inflammatory skin conditions, including, but not limited to, open lacerations or abrasions, hidradenitis, or dermatitis of the treatment area prior to treatment (duration of resolution as per the Investigator's discretion) or during the treatment course
- •Is taking medication(s) for which sunlight is a contraindication
- •Has a history of squamous cell carcinoma or melanoma
- •History of keloid scarring, abnormal wound healing and / or prone to bruising
- •History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders
- •Has used oral isotretinoin (Accutane®) within 12 months of initial treatment or plans on using during the course of the study. Note: Skin must regain its normal degree of moisture prior to treatment, e.g., lack of noticeable skin flaking, skin peeling and skin surface roughness.
- •A laser procedure, a peel or has used lightening creams that was performed in the area to be treated with the past six months
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications
- •Known allergy to lidocaine, tetracaine, Xylocaine or epinephrine
- •Subjects with pigmented lesions that are considered not acceptable by the study investigator or any condition that, in the investigator's opinion, would make it unsafe to treat.
- •As per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study
结局指标
主要结局
Efficacy of the PicoWayTM treatment
时间窗: from day 0 up to 13 months
assessed by blinded evaluators following 3 or 5 treatments, or at 12 weeks post final treatment.
次要结局
- Safety of the PicoWayTM(from day 0 up to 13 months)
- efficacy of the PicoWayTM fractional treatment by the investigator(after 3 weeks up to 13 months)
- Evaluate investigator satisfaction post treatments(after 46 weeks and after 52 weeks)
- subject satisfaction post treatments(after 46 weeks and after 52 weeks)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
不适用
Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.ScarsAcneNCT04806594Relife S.r.l.40
已完成
不适用
PillSense System for Detecting UGI BleedUGI BleedUpper Gastrointestinal BleedingUpper Gastrointestinal BleedNCT05385224EnteraSense Limited131
招募中
不适用
EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOnType B Aortic DissectionNCT06675617Intressa Vascular SA72
已完成
4 期
Rivastigmine Monotherapy and Combination Therapy With Memantine in Patients With Moderately Severe Alzheimer's Disease Who Failed to Benefit From Previous Cholinesterase Inhibitor TreatmentAlzheimer's DiseaseNCT00234637Novartis204
Unknown
1 期
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid TumorsAdvanced Solid TumorNCT05122572Wuxi People's Hospital36