Clinical Evaluation of Venus Versa SR Applicator Using Intense Pulsed Light on Skin Texture for Improving the Appearance of Striae Distensae
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Improvement in Striae Distensae Appearance
研究概览
简要总结
This trial is intended to evaluate the effect of IPL treatment on the Striae Distensae. The study hypothesis is that the SR580 applicator will improve the appearance of Striae Distensae by at least 1 point on the Global Aesthetic Improvement ScaleI (GAIS) at 3 months follow-up compared to baseline in at least 50% of the study population.
详细描述
Study Design This is a multi-site, prospective, open labeled clinical trial with before-after study design. This study will include up to 8 visits at the clinic: initial screening/consultation, 5 treatments, visits in 2 week intervals, and 2 follow-up visits at 1 and 3 months after the last treatment visit.
Up to 60 healthy subjects age 24-65 with Striae Distensae will be enrolled.
Study duration:
Duration of subject's participation: Up to 5.5 months from enrollment to termination
Blinding Objective assessment of clinical improvement by global assessment scale will be achieved by sending before/after pictures (baseline/3months after last treatment) to 3 blinded reviewers at the end of the study.
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
- 24 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to provide written Informed Consent;
- •Healthy male or female, 24-65 years Fitzpatrick-Goldman skin type I-V;
- •Having visible Striae Distensae to be treated (abdomen/thighs);
- •Comply with the treatment/follow-up schedule and requirements;
- •Women of child-bearing age are required to be using a reliable method of birth control
排除标准
- •Fitzpatrick-Goldman skin type VI;
- •Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after breastfeeding;
- •Heavy smoker
- •Unable or unlikely to refrain from tanning
- •Use of photosensitive medication
- •Use of oral isotretinoin within 3 months
- •Any dermal/epidermal damage or disorder in treated area
- •Prior treatment in treated area within 3 months
- •Prior skin laser/light or another device treatment in treated area within 6 months
- •Prior use of collagen, fat injections or other methods of skin augmentation in treated area within 12 months
- •Prior use of Botox in treatment area within 6 months
- •Prior ablative resurfacing procedure with laser in treatment area within 12 months
- •Any other surgery in treated area within 9 months
- •Participation in a study of another investigational device or drug as per the Investigator's discretion
- •History of keloid or any other type of hypertrophic scar formation or poor wound healing in a previously injured skin area
- •Showing symptoms of hormonal disorders (such as Melasma, Chloasma);
- •Concurrent inflammatory skin conditions, open laceration or abrasion of any sort on area to be treated during the course of treatment
- •Active Herpes Simplex at the time of treatment or having experienced more than three episodes of Herpes Simplex eruption within a year of study
- •Multiple dysplastic nevi in area to be treated
- •Having a bleeding disorder or taking anticoagulation medications
- •History of immunosuppression/immune deficiency disorders
- •Having any form of active cancer at the time of enrollment and during the course of the study or history of skin cancer
- •Pigmented lesion in the treated area that appears cancerous
- •Significant concurrent illness, such as uncontrolled diabetes
- •Active infections in the treated area
- •28.Tattoo or permanent makeup at the treatment area. 29.Mentally incompetent, prisoner or evidence of active substance or alcohol abuse 30.Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
结局指标
主要结局
Improvement in Striae Distensae Appearance
时间窗: 90 days following last IPL treatment
Striae distensae appearance improvement by at least 1 point on the Global Aesthetic Improvement scale (GAIS) from photographs 3 months following the last treatment as determined by 3 blinded reviewers where 3 = Very Much Improved, 2 = Much Improved, 1 = Improved, 0 = No Change, -1 = Worse, -2 = Much Worse and -3 = Very Much Worse.
次要结局
未报告次要终点