A Multicenter, Randomized, Subject-assessor Blind, Placebo Controlled Phase Ⅱ Study to Determine the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 4
- 主要终点
- Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
研究概览
简要总结
Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental fat.
详细描述
This study is to determine the optimal dose and evaluate safety and efficacy of Polyene Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female over 19 and under 65 years old.
- •Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit
- •Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit
- •Stable weight over the last 6 months (body weight change within +/- 5kg), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period.
- •Signed informed consent obtained before any study-specific procedure is performed.
排除标准
- •Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
- •Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
- •Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
- •Unable to undergo MRI by neurosis or general weakness.
- •History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
- •History of any treatment such as massotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, a botox surgery within 1 year before screening.
- •Inflammation, scars or surgery on the injection area.
- •Judged to be unsuitable subject for the clinical trials; ① Abnormal or sagging skin, ② Noticeable platysma band under the chin area, ③ Less or short chin than normal.
- •Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy.
- •History of or present symptoms of dysphagia.
- •Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening.
- •Requiring treatment of joint inflammation or a lung disease.
- •Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c> 9%).
- •Type 1 diabetes mellitus who needs insulin treatment.
- •Autoimmune disorder as well as those who takes immunodepressant drugs.
- •Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel.
- •Thyromegaly, thyrotoxicosis, or HIV-positive.
- •Diagnosed with malignant tumor within the last 5 years.
- •Severe renal dysfunction (serum creatinine > 2.0 mg/dl) or severe dyshepatia (ALT, aspartate aminotransferase(AST), alkaline phosphatase > maximum rate of normality x 2.5).
- •History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.).
- •History of taken a drug that can affect body weight or lipid metabolism such as anorectic agent, steroids, thyroid hormones, amphetamine, cyproheptadine, phenothiazine, or drugs that affect absorption, metabolism, and excretion within 3 months before screening.
- •History of other clinical trial studies within 3 months before screening.
- •Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, intrauterine contraceptive device, spermicide, condoms etc.).
- •Judged to be unsuitable subject for the clinical trials.
- •No or unable to using Smart phone to fill in the e-Pro.
- •Artificial or cavity teeth filled with metallic material (iron, gold, amalgam, cobalt, titanium) which makes misinterpret MRI.
研究组 & 干预措施
2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm
Participants receive 2.5% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
干预措施: Polyene phosphatidylcholine injection (Drug)
5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm
Participants receive 5.0% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
干预措施: Polyene phosphatidylcholine injection (Drug)
5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm
Participants receive 5.0% polyene phosphatidylcholine administered in 0.4 mL injections, 1.0 cm apart, up to 20.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
干预措施: Polyene phosphatidylcholine injection (Drug)
Placebo 0.2 mL/1.0 cm
Participants receive placebo administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
时间窗: Baseline and 12 weeks after last treatment
A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
次要结局
- Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)(Baseline and 12 weeks after last treatment)
- Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Compared to the Baseline(Baseline and 12 weeks after last treatment)
- Percentage of Participants Who Achieved a Composite 1-grade Response with Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline(Baseline and 12 weeks after last treatment)
- Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Pre-platysmal Area(Baseline and 12 weeks after last treatment)
- Change From Baseline in Participants With a Subject Self Rating Scale (SSRS) Response(Baseline and 12 weeks after last treatment)
- Change From Baseline in Depth of Cervical Mental Angle Analyzed with 3D Scanner(Baseline and 12 weeks after last treatment)
- Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area(Baseline and 12 weeks after last treatment)
- Percentage of Participants Who Achieved a Composite 2-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline(Baseline and 12 weeks after last treatment)
- Patient Global Impression of Change scale (PGIC)(12 weeks after last treatment)
- Change From Baseline in Derriford Appearance Scale 24 (DAS24)(Baseline and 12 weeks after last treatment)
- Change From Baseline in Body Image Quality of Life Inventory (BIQLI)(Baseline and 12 weeks after last treatment)