Evaluation of Safety and Efficacy of the BTL-785F Device for Non-invasive Facial Rejuvenation in Patients Injected With Botulinum Toxin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Facial Appearance Change
研究概览
简要总结
This study will evaluate the clinical safety and the efficacy of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive facial treatment in patients injected with botulinum toxin. The aim is to investigate the improvement of overall facial appearance and muscle tone.
详细描述
This study is a single-site, open-label, interventional study. The subjects will be enrolled and assigned into two experimental study arms (active and control group).
At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase (only for the active group) consists of four (4) treatment visits, delivered 5-10 days apart.
Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups.
Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment (the control group will not receive any treatment).
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 —（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 for reduction of wrinkles and overall aesthetic improvement of the face
- •Subjects injected with type A botulinum toxin for facial wrinkles improvement in the past month, but no sooner than 1 week
- •Subjects should be able understand the investigative nature of the treatment, the possible benefits and side effects, and must sign the Informed Consent Form
- •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 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
- •Electroanalgesia without exact diagnosis of pain etiology
- •Serious psychopathological disorders (such as schizophrenia)
- •Neurological disorders (such as multiple cerebrospinal sclerosis, epilepsy)
- •Blood vessels and lymphatic vessels inflammation
结局指标
主要结局
Facial Appearance Change
时间窗: 5 months
Three evaluators will evaluate facial appearance according to the Global Aesthetic Improvement Scale (GAIS) using the photographs taken at the baseline, last therapy visit and both follow-up visits. Each evaluator will be asked to assign a score to a set of photographs. The GAIS is a clinically validated assessment tool used to assess overall aesthetic improvement such as facelift on a scale from -1 through 3, where the higher score is considered better. The baseline and post-treatment scores will be compared. If applicable, the statistical significance of obtained results will be analyzed in Microsoft Excel spreadsheet software. The level of significance (α) will be set as 5%.
次要结局
- Therapy Comfort(5 months)
- Subject Satisfaction(5 months)
- Facial expression assessment(5 months)