The PREFORM Study: An Exploratory, Single-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring and Optimal Peri-Procedure Regimen for Accelerated Recovery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Number of Participants Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale
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. Rotational fractional resection is used to remove loose skin and fat.
详细描述
This is a prospective, single-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 moderate to severe submental skin laxity. The total duration of study participation for each subject is approximately up to 4 months for each subject from the screening visit to the exit visit. The follow-up period will be approximately 3 months after the procedure. Eligible subjects will complete a total of 11 study visits: screening, procedure, and follow-up visits at 1, 4, 7, 14, 21, 30, 45, 60, and 90 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 to severe submental laxity
- •Up to moderate submental lipodystrophy
- •Agree to maintain weight (±5%) for the duration of the study
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
- •Severe acne, cystic acne or acne scars on neck
- •Trauma of chin or neck area
- •Skin infection or rash on neck
- •Psoriasis, hyperpigmentation, eczema, rosacea or vitiligo
- •History of scarring
- •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 Who Had at Least One Grade Improvement on the Submental Skin Laxity Scale
时间窗: 90 days post treatment
Physician investigator rated the submental laxity using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
次要结局
- Number of Participants Who Were Satisfied With the Appearance of Their Neck and Jawline(90 days post treatment)
- Number of Participants With a One Grade Improvement on the Submental Lipodystrophy Scale(90 days post treatment)