Evaluation of the Safety and Effectiveness of BELKYRA® Inj. for the Treatment of Patients With Submental Fullness Due to Submental Fat: A Post Marketing Surveillance Study in Korea
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 71
- 试验地点
- 4
- 主要终点
- Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
研究概览
简要总结
The purpose of this PMS study is to evaluate the safety and effectiveness of BELKYRA Inj. used according to the dose specified in the instructions for use, for the treatment of patients with SM fullness due to SMF, through active investigation under routine clinical practice
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible and consenting Korean patients
- •Patients who have consented to the study and who have signed the private information protection act form or ICF
排除标准
- •Patients having infection at the infection sites
- •Patients presenting evidence of causes of enlarged submental area other than localized submental fat (E.g.: thyroid enlargement, enlarged submental salivary glands, cervical lymphadenopathy, etc.)
- •Patients participating in an interventional clinical study, currently or within 30 days before enrollment, will not be eligible for inclusion in the study
- •Pregnant women
- •Renal impairment patients
- •Hepatic impairment patients
- •Patients with severe laxity
研究组 & 干预措施
BELKYRA Inj.
Each patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart and follow-up within 3 months of the last treatment session.
干预措施: BELKYRA Inj. (Drug)
结局指标
主要结局
Change from baseline in Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
时间窗: Baseline, Follow up visit (within 3 months of injection)
Validated scale used by patients to evaluate SM size. Specifically, the PR-SMFRS asks patients to assess how much fat they have under their chins by selecting options ranging from "no chin fat at all" to "a very large amount of chin fat".
Change from baseline in Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
时间窗: Baseline, Follow up visit (within 3 months of injection)
A validated scale used by investigators to assess SM convexity/amount of SMF. Specifically, the CR-SMFRS ranges in whole number increments from 0 (absent submental convexity) to 4 (extreme submental convexity)
次要结局
未报告次要终点