A Clinical Study to Determine the Optimal Dose of Fat Reduction Injection (AYP-101) for the Reduction of Submental Fat in Chin Area
- Conditions
- Not Applicable
- Registration Number
- KCT0004034
- Lead Sponsor
- Amipharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 140
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ratio of subjects who improved at least 1 grade in both Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) after the 12 weeks of final treatment compared to baseline
- Secondary Outcome Measures
Name Time Method