Clinical and Histological Evaluation of BTL-785F Non-invasive Treatment for Facial Rejuvenation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Histological examination
研究概览
简要总结
This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-2 applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and correcting facial skin laxity.
详细描述
The changes in the skin tissue related to the levels of hyaluronic acid (HA) will be assessed histologically. The study is a prospective, single-center, three-arm, open-label study. The subjects will be enrolled and assigned into two treatment groups; group A (RF & USN) and B (only RF) which will receive a treatment with different settings. Subjects of both groups will be required to complete four (4) treatment visits and two follow-up visits. Additionally, a Control will be included to verify the treatment outcomes.
At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will be verified and informed consent will be signed. Punch biopsies of the facial skin for the examination of changes related to HA levels and photographs of the treated area will be taken.
The treatment administration phase in both treatment groups will consist of four (4) treatment visits, delivered 7 - 14 days apart.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 with non-invasive radiofrequency and ultrasound treatment for facial rejuvenation
- •Subjects should be able to 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 undergo punch biopsies in the infraauricular area.
- •Agreement to have their photographs taken for the purpose of this clinical investigation.
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 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 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 anti-aging or anti-wrinkles products in the treated area during the duration of the study including the follow-up period
- •Any other disease or condition at the investigator discretion that may pose risk to the patient or compromise the study
- •Any disease or condition contradicting the skin tissue biopsy
- •Any disease or condition that may compromise the histologic observation at the pathologist discretion
结局指标
主要结局
Histological examination
时间窗: 5 months
Evaluation of the facial skin tissue to assess the changes related to levels of HA in the biopsies obtained from both treatment groups and control.
次要结局
- Therapy Comfort(5 months)
- Evaluation of Overall Facial Appearance According to GAIS(5 months)
- Subject Satisfaction(5 months)
- Evaluation of Wrinkle Severity(5 months)