Status:
COMPLETED
Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area
Lead Sponsor:
AMIpharm Co., Ltd.
Conditions:
Moderate or Severe Submental Fullness
Eligibility:
All Genders
19-65 years
Phase:
PHASE2
Brief Summary
To determine the dosing interval, optimal dose, evaluate safety, and efficacy of AYP-101 S.C injection for the reduction of Submental Fat (SMF).
Detailed Description
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 sever...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05266729
Start Date
March 2 2022
End Date
February 20 2023
Last Update
August 15 2023
Active Locations (1)
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1
Chung Ang University Hospital
Seoul, South Korea, 06973