NCT05266729已完成2 期
A Single Center, Randomized, Placebo Controlled Phase Ⅱ Study to Determine the Dosing Interval and the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat
AMIpharm Co., Ltd.1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年3月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Percentage of subjects who improved at least 1 grade in both Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and Subject-Reported Submental Fat Rating Scale (PR-SMFRS)
研究概览
简要总结
To determine the dosing interval, optimal dose, evaluate safety, and efficacy of AYP-101 S.C injection for the reduction of Submental Fat (SMF).
详细描述
This study is to determine the dosing interval, optimal dose, evaluate safety and efficacy of AYP-101 S.C injection for the reduction of 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
- Double (Participant, Investigator)
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
- •Localized submental fat under chin area and who meet all the following criteria.
- •① Determined as grade 2 (moderate) or 3 (severe) on both using the CR-SMFRS and PR-SMFRS at visit 1
- •② Determined as grade 2 (less satisfied) or less by oneself, using the SSRS at visit 1
- •Stable weight over the last 6 months (body weight change within +/-10%), subject who should refrain from exercise and diet that may affect the study results, and who agreed to remain it for the study period
- •Singed informed consent
排除标准
- •Allergic to beans, components of the clinical drug, or medical devices which used in this clinical trial (lidocaine, acetaminophen, sterile oil pan, alcohol swab, grid pad, needle, etc.)
- •Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more)
- •History of any treatment (orthognathic surgery, suction lipectomy, PPC or DCA injection) in the neck or chin area
- •History of any treatment such as mesotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling with in 1 year, and a botox surgery within 6 months before screening
- •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 ④ Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy, Inflammation, scars, or surgery on the injection area
- •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, 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 6 months before screening
- •Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, IUCD, spermicide, condoms etc.)
- •Judged to be unsuitable subject for the clinical trials
研究组 & 干预措施
AYP-101 1
Experimental
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
干预措施: Polyene Phosphatidylcholine (Drug)
AYP-101 2
Experimental
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
干预措施: Polyene Phosphatidylcholine (Drug)
Placebo
Placebo Comparator
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of subjects who improved at least 1 grade in both Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and Subject-Reported Submental Fat Rating Scale (PR-SMFRS)
时间窗: 4 weeks after the final treatment
Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
次要结局
- Percentage of subjects who improved at least 1 grade of Subject-Reported Submental Fat Rating Scale (SR-SMFRS)(4 and 12 weeks after the final treatment)
- Volume difference of pre-platysmal submental fat around chin area(4 weeks after the final treatment)
- Volume difference of platysmal submental fat around chin area(4 weeks after the final treatment)
- Percentage of subjects who improved at least 2 grades in both Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and Subject-Reported Submental Fat Rating Scale (SR-SMFRS)(4 and 12 weeks after the final treatment)
- Difference of Subject Self Satisfaction Scale (SSSS)(4 and 12 weeks after the final treatment)
- Difference of volume of submental fat around chin area analyzed with 3D(4 weeks after the final treatment)
- Percentage of subjects who improved at least 1 grade in both Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and Subject-Reported Submental Fat Rating Scale (SR-SMFRS)(12 weeks after the final treatment)
- Percentage of subjects who improved at least 1 grade of Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS)(4 and 12 weeks after the final treatment)
- Difference of Patient-Reported Submental Fat Impact Scale (PR-SMFIS) score(4 and 12 weeks after the final treatment)
- Difference of Derriford Appearance Scale 24 (DAS24)(4 weeks after the final treatment)
- Patient Global Impression of Change scale (PGIC)(4 weeks after the final treatment)
- Difference of Body Image Quality Life Inventory (BIQLI) score(4 weeks after the final treatment)
研究者
研究点 (1)
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