Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Reduction of Wrinkles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale
研究概览
简要总结
This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles.
详细描述
This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with BTL-785-2 applicator for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete three (3) treatment visits and two follow-up visits. At every treatment visit after the first, prior to the procedure, the participants will be assessed for adverse effects resulting from the previous treatment(s) with the BTL-785F device.
Safety measures will include documentation of adverse events (AE) during and after the procedures.
Follow-ups visits at 3 months and 6 months after the final treatment will be held.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects over 21 years of age seeking treatment and reduction of facial wrinkles
- •Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
- •Presence of clearly visible wrinkles in the treated area when the face is relaxed as deemed appropriate by the Investigator
- •Subjects willing and able to abstain from partaking in any facial treatments other than the study procedure during study participation
- •Willingness to comply with study instructions, to return to the clinic for the required visits, and to have photographs of their face taken
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/or chemotherapy
- •Poor healing and unhealed wounds in the treatment area
- •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 6 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 type of cancer
- •Active collagen diseases
- •Cardiovascular diseases (such as vascular diseases, peripheral arterial disease, thrombophlebitis and thrombosis)
- •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
- •Acute neuralgia and neuropathy
- •Kidney or liver failure
- •Sensitivity disorders in the treatment area
- •Varicose veins, pronounced edemas
- •Prior use of dermal fillers, botulinum toxin, lasers, etc. therapies in the treated area that can influence the study results at the investigator discretion
- •Unwillingness/inability to not change their usual cosmetics and especially not to use ani-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
- •Unwillingness/inability to abstain from cosmetic procedures in the treated area at least 15 days before every examination with the facial image analysis system VISIA
- •Any other disease or condition (e.g. eye disease) at the investigator discretion that may pose risk to the patient or compromise the study
结局指标
主要结局
Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale
时间窗: 3 months
Gathering of clinical evidence that the Device is able to achieve reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline.
次要结局
- Assess safety profile by recording of adverse events(7 months)
- Assess subjects' satisfaction with the treatment using Subject Satisfaction Questionnaire(6 months)