The CONFORM Study: A Multi-center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 12
- 主要终点
- Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2
研究概览
简要总结
This study will evaluate the safety and efficacy of rotational fractional resection (RFR) to improve neck contouring. RFR is used to remove loose skin and fat.
详细描述
This is a prospective, multi-center, single-arm (non-randomized), interventional cohort, non-significant risk (NSR) study designed to investigate the efficacy and safety of Rotational Fractional Resection (skin resection and focal lipectomy) in patients with mild to moderate submental fat and mild to moderate submental skin laxity. The total duration of study participation for each subject is approximately up to 7 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 6 months after the procedure. Eligible subjects will complete a total of 8 study visits: screening, procedure, and follow-up visits at 1, 7, 14, 30, 90 and 180 days post-procedure.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female, at least 30 years old
- •Moderate submental (neck) fat
- •Mild to moderate submental (neck) skin laxity (loose skin)
- •Willing and able to provide informed consent
- •Willing and able to comply with all protocol requirements
- •Willing to limit direct sun exposure and use sunscreen for duration of the study
- •Agree to maintain weight for duration of the study
- •Willing to have photographs taken that could identify the participant
排除标准
- •Previous intervention to treat submental fat or skin laxity
- •Use of aspirin, ibuprofen, naproxen, or Vitamin E within 14 days of the procedure
- •Sensitivity to local anesthesia
- •Severe acne, cystic acne or acne scars on neck
- •Trauma of chin or neck area
- •Skin infection or rash on neck
- •Psoriasis, eczema, rosacea, or vitiligo
- •History of scarring
- •History or current symptoms of dysphagia
- •Chronic or persistent coughing
- •Body mass index (BMI) > 30
- •Clinically significant bleeding disorder
- •Anemia, kidney disease, or liver disease
结局指标
主要结局
Number of Participants With a Reduction of Submental Skin Area ≥ 20 mm^2
时间窗: Baseline and 90 days post treatment
This endpoint is the difference in the measurement of submental skin area (mm\^2) between Baseline and 90 days. A reduction of ≥ 20 mm\^2 denotes improvement.
次要结局
- Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline(90 days after treatment)
- Number of Participants With Post-treatment Images Correctly Identified(Pre-treatment and 90 days after treatment)