Safety and Efficacy Evaluation of SMART Camera Treatment Presets for Cutaneous Lesions Using IPL
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
- To study the safety of the suggested treatment presets as suggested by the SMART IPL system platform for cutaneous lesions in subjects with skin types I-V
研究概览
简要总结
Multi-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive a single treatment. Treatment presets will be determined by the SMART Camera system and approved by the physician. Follow-up will take place at 1 month following the treatment. Skin and lesion attributes will be examined by the SMART system and the physician
详细描述
At least 40 healthy subjects in 2 sites, aged 21-80 years old with visible textural lesions including but not limited to Lentigines, Rosacea, and Age spots / Telangiectasia on the face or décolletage that wish to improve their skin appearance. Each patient should have at least 3 treatment areas (e.g. left cheek, right cheek, forehead, nose, chin, upper/lower décolletage) that contains at least one type of lesion
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- 是
入选标准
- •Healthy Female/Male, age 21-
- •Fitzpatrick skin type I-V.
- •Presence of visible textural lesions including but not limited to:
- •Lentigines
- •Rosacea (erythematotelangiectatic rosacea and papulopustular rosacea)
- •Age spots/Telangiectasia
- •Telangiectasia
- •Patients should have at least 3 treatment areas of the following: right cheek, left cheek, forehead, nose, chin, and upper/lower décolletage.
- •Able to read, understand and provide written Informed Consent.
- •Able and willing to comply with the treatment/follow-up schedule and requirements.
- •Willing to have digital photographs taken of all of the treatment areas before, during, and after treatment.
- •Willing to refrain from using any prescription or over-the-counter topical creams used for the treatment of veins or pigmented lesions in the treatment area during the study period.
- •Willing to protect and/or have very limited sun exposure and use an approved sunscreen of SPF 50 or higher in the treatment area, every day for the duration of the study.
- •Agree not to undergo any other procedure(s) in the same treatment areas during the study.
- •Women of child-bearing age are required to be using a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, or abstinence) at least 3 months prior to enrollment and throughout the course of the study.
排除标准
- •Any of the following will exclude the subject from the study:
- •Previous treatments on the same area/s at least six months prior to screening
- •Skin type VI
- •Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- •Exposure to the sun or artificial tanning during 3-4 weeks prior to treatment. Any remaining suntan, sunburn, or artificial tanning products.
- •Active infections in the treatment area
- •Dysplastic nevi
- •Significant concurrent skin conditions or any inflammatory skin conditions
- •Active cold sores, open lacerations, or abrasions
- •Chronic or cutaneous viral, fungal or bacterial diseases
- •Treatment should not be attempted on patients with a history or concurrent condition of skin cancer or pre-cancerous lesions in the treatment area
- •Tattoos in the areas to be treated
结局指标
主要结局
To study the safety of the suggested treatment presets as suggested by the SMART IPL system platform for cutaneous lesions in subjects with skin types I-V
时间窗: 3 month
Treatment with the SMART IPL system will be considered safe when a full treatment is completed using the recommended presets by the AI system (presets are not overruled due to safety by the physician) with no serious AEs. The overall percentage of safe treatments using the AI-recommended presets from all treatments will be calculated through study completion, an average of 3 months.
To study the efficacy of the SMART IPL system for cutaneous lesions treatment in subjects with skin types I-V
时间窗: 4 months
Lesions clearance will be evaluated by the investigator at a 1-month follow-up compared to baseline using a 5-point clearance scale, when 0 is no clearance, and 4 is 76-100% clearance. Evaluation will be completed through study completion, an average of 4 months.
次要结局
未报告次要终点