NCT01426373已完成3 期
Multicenter, Open-label Study of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area
Kythera Biopharmaceuticals18 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2011年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 18
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
To evaluate the safety of deoxycholic acid subcutaneous injections in the submental area (below the chin).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Submental fat graded by the investigator as 2, 3, or 4 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2, 3, or 4 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on visit 1 (within 28 days before the subject's first dosing session)
- •Dissatisfaction with the submental area rated by the subject as 0, 1, or 2 using the Subject Self-rating Scale (SSRS) as determined on visit 1 (within 28 days before the subject's first dosing session)
- •Males and nonpregnant, nonlactating females 18 years of age or greater, on the day of the subject's first dosing session (visit 2). Females of childbearing potential must have a negative human chorionic gonadotropin (serum) test result within 28 days before visit 2 and agree to practice adequate contraception, in the judgment of the investigator, during the course of the study
- •A normal result on coagulation tests (prothrombin time (PT), partial thromboplastin time (PTT)) obtained within 28 days before subject's first dosing session
- •History of stable body weight, in the judgment of the investigator, for at least 6 months before subject's first dosing session
- •Expected to understand and comply with the visit schedule and all protocol-specified tests and procedures and agreement by the subject to refrain from making significant changes, in the judgment of the investigator, to his or her dietary or exercise habits during the course of the subject's participation
- •Medically able to undergo the administration of study drug determined by clinical and laboratory tests obtained within 28 days before subject's first dosing session for which the investigator identifies no clinically significant abnormality
- •Signed informed consent obtained before any study-specific procedure is performed
排除标准
- •History of any intervention to treat submental fat (eg, liposuction, surgery, or lipolytic agents)
- •History of trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
- •A grade of 4 on the Submental Skin Laxity Grading scale (SMSLG) or any other anatomical feature (eg, predominant subplatysmal fat, loose skin in the neck or chin area, prominent platysmal bands) for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome
- •Evidence of any cause of enlargement in the submental area (eg, thyroid enlargement, cervical adenopathy) other than localized submental fat
- •Body mass index of ≥ 40 kg/m² as determined on visit 1 (week 0)
- •History or current symptoms of dysphagia
- •Any medical condition that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or give informed consent
- •Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before the first treatment session, or botulinum toxin injections in the neck or chin area within 6 months before the first treatment session
- •History of sensitivity to any components of the study drug or to topical or local anesthetics (eg, lidocaine, benzocaine, novocaine)
- •Previous treatment in this study or previous participation in a Kythera-sponsored ATX-101 study
- •Treatment with an investigational device or agent within 30 days before the subject's first treatment session
研究组 & 干预措施
Deoxycholic Acid 2 mg/cm²
Experimental
Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
干预措施: Deoxycholic acid injection (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to 12 months after last treatment (maximum of 18 months from first treatment)
Serious AEs include any event that met one or more of the following criteria: was fatal or life-threatening, required inpatient hospitalization or prolonged a hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or a significant medical hazard. The severity of each AE was defined as either: Mild: The participant was aware of the sign or symptom, but it was easily tolerated. Moderate: The sign or symptom caused discomfort and interfered with usual activity. Severe: The sign or symptom was incapacitating, and the participant was unable to engage in usual activity. The investigator determined the relationship of each AE to the study drug using the question: "Is there a reasonable possibility that the event may have been caused by treatment with the study drug?"
次要结局
- Percentage of Participants Who Achieved a Composite 2-grade Response(Baseline and month 3 and month 12 after last treatment)
- Response to Subject Global Questions(Month 3 and month 12 after last treatment)
- Mean Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)(Baseline and month 3 and month 12 after last treatment)
- Mean Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (CR-SMFRS)(Baseline and months 3, 6, 9, and 12 after last treatment)
- Mean Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)(Baseline and month 3 and month 12 after last treatment)
- Mean Change From Baseline in Subject Self Rating Scale (SSRS)(Baseline and month 3 and month 12 after last treatment)
- Percent Change From Baseline in Submental Fat Thickness(Baseline and month 3 and month 12 after last treatment)
- Percentage of Participants Who Achieved a Composite 1-grade Response(Baseline and month 3 and month 12 after last treatment)
- Mean Change From Baseline in Self-rating of Attractiveness(Baseline and month 3 and month 12 after last treatment)
- Change From Baseline in Submental Skin Laxity Grade (SMSLG)(Baseline and month 3 and month 12 after last treatment)
- Change From Baseline in Line Drawing Assessment(Baseline and month 3 after last treatment)
研究者
研究点 (18)
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