KCT0004034招募中未知
A multicenter, Randomized, Subject-assessor blind, Placebo controlled Phase ? study to determine the optimal dose of AYP-101 S.C. injection for the reduction of submental fat
Amipharm0 个研究点目标入组 140 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19?(Year) 至 65?(Year)（—）
- 性别
- All
入选标准
- •1) Male and female over 19 and under 65 years old
- •2) Localized submental fat under chin area and who meet all the following criteria.
- •? Determined as grade 2 (moderate) or 3 (severe) on both using the CR-SMFRS and PR-SMFRS at visit 1
- •? Determined as grade 2 (less satisfied) or less by oneself, using the SSRS at visit 1
- •3) 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
- •4) Singed informed consent
排除标准
- •1) Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.)
- •2)Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen
- •3) Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more)
- •4) Unable to undergo MRI by neurosis or general weakness
- •5) History of any treatment (orthognathic surgery, suction lipectomy, PPC injection) in the neck or chin area
- •6) History of any treatment such as mesotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, abotox surgery within 1 year before screening
- •7) Inflammation, scars or surgery on the injection area
- •8) Judged to be unsuitable subject for the clinical trials; ? Abnormal or sagging skin, ? Noticeable platysma band under the chin area, ? Less or short chin than normal
- •9) Chin or neck disease that are considered to have an impact on the clinical trial such as lymphadenopathy
- •10) History of or present symptoms of dysphagia
- •11) Heart disease (cardiac insufficiency, angina, cardiac infarction) or stroke within 6 months before screening
- •12) Requiring treatment of joint inflammation or a lung disease
- •13) Uncontrolled hypertension (systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg) or type 2 diabetes mellitus (HbA1c> 9%)
- •14) Type 1 diabetes mellitus who needs insulin treatment
- •15) Autoimmune disorder as well as those who takes immunodepressant drugs
- •16) Hemostatic disorder or those who takes anticoagulant drug such as warfarin and clopidogrel
- •17) Thyromegaly, thyrotoxicosis, or HIV-positive
- •18) Diagnosed with malignant tumor within the last 5 years
- •19) Severe renal dysfunction (serum creatinine > 2.0 mg/dl) or severe dyshepatia (ALT, AST, alkaline phosphatase > maximum rate of normality x 2.5)
- •20) History of serious psychiatric disease (Depression, schizophrenia, epilepsy, alcoholism, drug addiction, anorexia, anorexia nervosa, etc.)
- •21) 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
- •22) History of other clinical trial studies within 3 months before screening
- •23) Women who are pregnant, breastfeeding, having pregnancy plan, or did not agreed to the contraception (contraceptive pills, contraceptive hormones, IUCD, spermicide, condoms etc.)
- •24) Judged to be unsuitable subject for the clinical trials
- •25) No or unable to using Smart phone to fill in the e-Pro
- •26) Artificial or cavity teeth filled with metallic material (iron, gold, amalgam, cobalt, titanium) which makes misinterpret MRI
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