Safety and Efficacy of the BTL-FR2000 Device for the Treatment of Facial Wrinkles
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement of facial wrinkles evaluated through the change in the value of the validated scale
研究概览
简要总结
The study will evaluate safety and effectivity of the BTL-FR2000 device for the treatment of facial wrinkles.
详细描述
Subjects will be photographed at the baseline visit. After the treatment phase, subjects will be invited for two follow-up visits - 3 and 6 months after the last therapy. They will be again photographed.
Three blinded evaluators will be scoring the full face photos according to the Fitzpatrick Wrinkle Severity Scale. The improvement of the scores will be evaluated. Every subject will serve as its own control.
In addition, the occurence of an AE during the whole study, as well as the therapy discomfort during the treatment phase, will be followed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 22 years
- •Voluntarily signed informed consent form
排除标准
- •Bacterial or viral infection, acute inflammations
- •Impaired immune system
- •Isotretinoin in the past 12 months
- •Skin related autoimmune diseases
- •Radiation therapy and chemotherapy
- •Poor healing and unhealed wounds in the treatment area
- •History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin
- •Metal implants
- •Permanent implant in the treated area
- •Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body
- •Facial dermabrasion, facial resurfacing, or deep chemical peeling in the treatment area within 3 months prior to the treatment
- •Current or history of skin cancer, or current condition of any other type of cancer, or pre-malignant moles
- •History of any kind of cancer
- •Active collagen diseases
- •Cardiovascular diseases (such as cardiac and vascular diseases, peripheral arterial disease, thrombophlebitis, thrombosis, etc.)
- •Pregnancy/nursing or IVF procedure
- •History of bleeding coagulopathies, use of anticoagulants
- •Any active condition in the treatment area, such as sores, psoriasis, eczema, rash and rosacea
- •Any surgical procedure in the treatment area within the last three months or before complete healing
- •Poorly controlled endocrine disorders, such as diabetes
- •Children under age of 21
- •Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks
- •Patients with allergy to anesthetics should not be treated under anesthesia
- •Botox®/collagen/fat injections or other injected bio-material in the treated area within three months prior to treatment
- •Use of non-steroidal anti-inflammatory drugs one week before and after each treatment session
- •Treating over tattoo or permanent makeup
研究组 & 干预措施
Treatment Group
Treated group of subjects, serves as its own control
干预措施: BTL-703 (Treatment group) (Device)
结局指标
主要结局
Improvement of facial wrinkles evaluated through the change in the value of the validated scale
时间窗: 10 months
Three blinded evaluators will be evaluating the full-face photographs taken at the baseline, last therapy visit and both follow-up visits. They will be evaluating it using the validated Fitzpatrick Wrinkle Severity Scale. According to that scale, subjects are divided in three categories (I, II, III) corresponding to mild, moderate, and severe wrinkling, and degree of elastosis. In addition, a score of 1 to 9 (a linear sliding scale to represent increasing severity of wrinkling) will be given. The change in score (value) from the scale before and after the treatment will be calculated.
次要结局
- Safety - Occurence of AE(10 months)
- Safety - Therapy comfort(4 months)