Evaluation of the Immediate Effect and Safety of DMA™ Novel Muscle Stimulation Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- To evaluate the immediate effects and safety of DMATM novel muscle stimulation technology on the face, buttocks, and abdominal regions: GAI scale
研究概览
简要总结
A total of at least 15 and up to 17 healthy subjects at a single site, aged 25-45 years old, who wish to receive a lifting effect and improved muscle definition, will be included in the study.
The procedure will include treatments with the Legend Pro™ DMA™ technology. Photos will be obtained at pre-defined time points throughout the study.
详细描述
Single center, prospective, open Label with Before & After Study Design. This study is designed to evaluate the immediate efficacy and safety of Legend Pro™'s DMA™ muscle stimulation technology. Treatment areas will include the face, buttocks, or abdominal region. Each subject will receive 1 treatment with no follow-up visits required. Interim assessment will be held after half of the study population has received treatment.
The study population will be divided into three arms as follows:
- 5 female subjects will receive treatment in the face area
- 5 female subjects will receive treatment in the buttocks area
- 5 male subjects will receive treatment in the abdominal region
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
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject read, understood and signed the Consent Form
- •Healthy male or female aged 25-45 years,
- •Fitzpatrick skin type 1-6
- •Subject is capable of reading, understanding and following instructions of the procedure to be applied.
- •Subject is able and willing to comply with the treatment.
- •Women of child-bearing potential are required to use two forms of reliable methods of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study.
排除标准
- •Subject is female who is pregnant, lactating, or plans to become pregnant during the study period or had given birth less than 6 months ago.
- •Concurrent participation in any other study.
- •Specific to the treatment and treatment area
- •Subject has a pacemaker or internal defibrillator, implanted neurostimulators or any other internal electric device or patient who had an implant in the past.
- •Subject has metal or other implants in the treatment area (Not including dental fillings, implants and crowns).
- •Subject has significant concurrent skin conditions affecting areas to be treated such as sores, bleeding, skin fragility, eczema or psoriasis.
- •Subject has burned, blistered, irritated, or sensitive skin due to excessive fresh tanning in areas to be treated or is unlikely to refrain from excessive tanning during the study.
- •Other treatments
- •Subject has used oral isotretinoin (Accutane or Roaccutan®) within 6 months prior to study enrollment or plans use during the course of the study.
- •Subject has used topical retinoids in past 1 month
- •Medical conditions/ use of medication
- •Subject has current or history of systemic cancer; premalignant skin lesion or skin concern treatment area.
- •Subject has severe concurrent conditions such as epilepsy, autoimmune, pulmonary or cardiac disorders.
- •Subject has poorly controlled endocrine disorders such as diabetes.
- •Subject has an impaired immune system due to immunosuppressive diseases such as HIV or AIDS, or use of immunosuppressive medications.
- •Subject has history of collagen disorders, keloid formation or abnormal wound healing.
- •Subject takes or has taken medications, herbal preparations, food supplements or vitamins that might cause fragile skin or impaired skin healing
- •Subject has used oral steroids in past 6 months
- •Subject has used topical steroids in past 3 months
- •Subject has history of bleeding coagulopathies or use of anticoagulants.
- •Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen containing agents) one week before and after each treatment session prior to treatment
- •Subject has mental disorders that in the opinion of the Investigator would be interfere with ability to comply with the study requirements.
- •Subject has any other medical condition that in the opinion of the Investigator warrants exclusion from this study
结局指标
主要结局
To evaluate the immediate effects and safety of DMATM novel muscle stimulation technology on the face, buttocks, and abdominal regions: GAI scale
时间窗: 6 months
Efficacy of the treatment will be based on before and after photography. Efficacy will be established by the Global Aesthetic Improvement scale (GAI) completed by the Principal investigator. Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, as compared to baseline. Global Aesthetic Improvement (GAI) Scale: Worse (0), No change (1), Somewhat improved (2), Moderately improved (3), Very Much Improved (4)
次要结局
- To evaluate procedure-related skin safety, subject discomfort, and subject satisfaction: questionnaire(6 months)