Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response
研究概览
简要总结
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（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 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) as determined on Visit
- •Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using the Subject Self Rating Scale (SSRS).
- •Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive on the day of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (hCG) test result within 28 days before randomization and agree to practice medically acceptable birth control during the course of the study. Medically acceptable birth control includes: surgical sterilization, hormonal contraceptives, barrier methods or an intrauterine device (IUD).
- •History of stable body weight, in the judgment of the investigator, for at least 6 months before randomization. No significant change, in the judgment of the investigator, in diet or exercise practices for at least 6 months before randomization and agreement to not change diet or exercise practices during the course of the study.
- •Expected to comply with and understand the visit schedule and all protocol-specified tests and procedures.
- •Medically able to undergo the administration of study material determined by clinical evaluations made within 56 days before and laboratory tests obtained within 28 days before randomization for which the investigator identified 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 (e.g., liposuction, surgery, or lipolytic agents) or trauma associated with the chin or neck areas, which in the judgment of the investigator may affect evaluation of safety or efficacy of treatment.
- •Loose skin in the neck or chin area for which reduction in submental fat may, in the judgment of the investigator, result in an aesthetically unacceptable outcome or a score of 4 on the Skin Laxity Rating Scale (SLRS).
- •Prominent platysmal bands at rest or other anatomical features that, in the judgment of the investigator, may interfere with the evaluation of submental fat or result in an aesthetically unacceptable outcome.
- •Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement or cervical adenopathy) other than localized submental fat.
- •Body mass index (BMI) greater than
- •Currently on or considering starting a weight reduction regimen.
- •Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with assessment of safety or efficacy or compromise the subject's ability to undergo study procedures or provide informed consent.
- •Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections in the neck or chin area within 6 months before randomization.
- •History of sensitivity to any components of the study material or to topical or local anesthetics (e.g., lidocaine, benzocaine, or novocaine).
- •Previous randomization into this study or previous treatment with ATX-
- •Treatment with an investigational device or agent within 30 days of randomization.
研究组 & 干预措施
Placebo
Participants received placebo 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 4 treatments.
干预措施: Placebo (Drug)
Deoxycholic Acid Injection 1 mg/cm²
Participants received deoxycholic acid 1 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 4 treatments.
干预措施: Deoxycholic acid injection (Drug)
Deoxycholic Acid Injection 2 mg/cm²
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 4 treatments.
干预措施: Deoxycholic acid injection (Drug)
结局指标
主要结局
Percentage of Participants With a Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) 1-grade Response
时间窗: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
A CR-SMFRS response is defined as at least a 1-point improvement (i.e. 1-point reduction) from Baseline 12 weeks after the last treatment. The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Percentage of Participants With a Subject Self Rating Scale (SSRS) Response
时间窗: Baseline and 12 weeks after last treatment (up to 24 weeks after first dose)
A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
次要结局
- Change From Baseline in Submental Fat Thickness(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))
- Change From Baseline in SSRS Scores(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))
- Percentage of Participants With a CR-SMFRS 2-grade Response(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))
- Change From Baseline in CR-SMFRS Score(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))
- Change From Baseline in Body Image Quality of Life Inventory (BIQLI)(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))
- Change From Baseline in Derriford Appearance Scale 24 (DAS24)(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))
- Change From Baseline in Patient-reported Submental Fat Rating Scale (PR-SMFRS)(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))
- Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))
- Change From Baseline in Self-rating of Attractiveness(Baseline and 12 weeks after last treatment (up to 24 weeks after first dose))