The INFORM Study: A Multi-Center Study to Evaluate the Safety and Efficacy of Rotational Fractional Resection on Submental Contouring With an Optimized Post-Procedure Treatment Plan
试验速览
- 阶段
- 不适用
- 入组人数
- 21
- 试验地点
- 27
- 主要终点
- Improved Skin Laxity
研究概览
简要总结
Efficacy and safety of Rotational Fractional Resection (skin resection) in patients with moderate to severe submental skin laxity.
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) 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, 2-4, 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
- •Agree to maintain weight (±5%) for the duration of the study
排除标准
- •Greater than mild submental fat
- •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
Improved Skin Laxity
时间窗: Pre-treatment and 90 days after treatment
Comparison of the submentum before and after procedure using the Submental Skin Laxity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe)
Subject Satisfaction: Subject Satisfaction Questionnaire
时间窗: Pre-treatment and 90 days after treatment
Comparison of Subject satisfaction of the procedure as assessed using the Subject Satisfaction Questionnaire
次要结局
未报告次要终点