NCT05358860已完成不适用
Safety and Efficacy of Sofwave Treatment for Acne Scars Appearance Improvement
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Rate of change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session.
研究概览
简要总结
Open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.
详细描述
Eligible patients will receive 3 treatments (4-6 weeks apart) on the facial acne scars using Sofwave System.
Treatment may be administered after the enrollment and screening at the first visit, or it may occur later following the enrollment and screening activities based on site scheduling availabilities.
All patients will return to the clinic for one follow up visit at 3 months ± 3 weeks post last treatment (FU1). 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
- 22 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects > 22 years of age and < 80 years of age.
- •For female subjects, not pregnant or lactating and must be 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.
- •Seeking treatment for facial acne scars.
- •Have visible mild to moderate facial acne scars.
- •Agree not to undergo any other facial acne scars treatments for a period of 3 months following Sofwave treatments.
- •Willing to have photographs of the treated areas. Agree for de-identified study images to be used in evaluations, publications and presentations.
- •Able and willing to comply with all visits, treatments and evaluations schedules and requirements.
- •Able to understand and provide written Informed Consent
排除标准
- •Pregnant or planning to become pregnant during the duration of the study, having given birth less than 3 months ago, and/or breast feeding
- •Current smoker or has history of heavy smoking (25 cigarettes per day or more) in past 10 years.
- •History of severe migraine tendency.
- •History of Epileptic seizures.
- •History of chronic drug or alcohol abuse.
- •Taking Isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks.
- •Medical disorder that may hinder the wound healing or immune response (such as blood disorder, inflammatory disease, etc.)
- •Presence of a metal stent or implant in the facial area.
- •Known allergy to tetracaine, Xylocaine or epinephrine.
- •Active malignancy or history of malignancy in the past 5 years.
- •Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria, or pertinent neurological disorders (i.e. any disease state that in the opinion of the investigator may interfere with the anesthesia, treatment, or healing process).
- •History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
- •Presence of any active systemic or local infections.
- •Severe or cystic facial acne, acutance uses during past 6 months.
- •History of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the 6 months; injectable (Botox or fillers of any type) within the 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift or blepharoplasty within the past 12 months.
- •Inability to understand the protocol or to give informed consent
- •On-going use of psychiatric medication
- •Unable or unwilling to comply with the study requirements and procedures
- •Currently enrolled in a clinical study of any other unapproved investigational drug or device
- •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
Acne Scars
Experimental
干预措施: Sofwave (Device)
结局指标
主要结局
Rate of change of acne scars appearance, as assessed by independent masked evaluators at 3 months post last treatment session.
时间窗: 1 year
following Sofwave treatments based on 6 points simplified Acne Severity Scale (ASS), as evaluated by independent masked reviewers.
次要结局
未报告次要终点
研究者
研究点 (4)
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