None listed
Conditions
Interventions
Drug : AYP-101 (125mg/5mL and 250mg/5mL of Polyene PhosphatidylCholine) and Placebo
Dosage: 0.2cc to 0.4cc dose per point, maximum dose per point was set to 250mg / 10ml, 500mg / 10ml, 1000mg / 20ml,
Sponsors
Amipharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Difference of Patient-Reported Submental Fat Impact Scale (PR-SMFIS) score after 12 weeks of final treatment compared to baseline;Percentage of subjects who improved at least 1 grade of Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) after 12 weeks of final treatment compared to baseline;Percentage of subjects who improved at least 1 grade of Patient-Reported Submental Fat Rating Scale (PR-SMFRS) after 12 weeks of final treatment compared to baseline;Volume difference of platysmal submental fat around chin area after 12 weeks of final treatment compared to baseline;Patient Global Impression of Change scale (PGIC) after 12 weeks of final treatment;Difference of Derriford Appearance Scale 24 (DAS24) score after 12 weeks of final treatment compared to baseline;Difference of Body Image Quality Life Inventory (BIQLI) score after 12 weeks of final treatment compared to baseline;Adverse events (AE to the localized injection area or total body);Blood test, blood chemical test, urine test, blood coagulation test, etc.;Difference of depth of Cervical Mental Angle analyzed with 3D after 12 weeks of final treatment compared to baseline;physical examination and vitals sign;Percentage of subjects who improved at least 2 grades in both Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) after 12 weeks of final treatment compared to baseline;Difference of Subjective Self-Rating Scale (SSRS) after 12 weeks of final treatment compared to baseline;Volume difference of pre-platysmal submental fat around chin area after 12 week of final treatment compared to baseline | — |
Countries
Korea, Republic of
Contacts
Public ContactBok Ki Jung
Yonsei University Health System, Severance Hospital
Outcome results
None listed