NCT04640207已完成不适用
Prospective, Single-Center, Open-Label Study to Evaluate the Efficacy of the Alma Hybrid System for New Approach of Facial Skin Treatment With Minimal Downtime
Alma Lasers2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年11月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Investigator assessment
研究概览
简要总结
The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths.
The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. Follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.
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
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Male or Female, 35 to 60 years of age, at the time of enrollment
- •Fitzpatrick skin type I-IV
- •Mild-moderate photo damages and wrinkles, with Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6
排除标准
- •Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- •Heavy smoker (>1 pack of cigarettes a day)
- •Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
- •Previous rejuvenation treatments on the same area, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure, or face-lift with laser or other devices, up to 3 months prior to the enrollment
- •Prior use of collagen, fat injections, or other methods of skin augmentation within the past 12 months.
- •Prior use of Botox in the treatment area within 5 months
- •Infection, dermatitis, rash, or other skin abnormality in the target area
- •History of any disease or condition that could impair wound healing
- •History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
结局指标
主要结局
Investigator assessment
时间窗: 3 month after last treatment
Investigator assessment of the overall facial skin aesthetic appearance using a 5 point Likert scale (when "1" indicate "not at all improved" and "5" indicates " very much improved"
次要结局
未报告次要终点
研究者
研究点 (2)
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