Clinical trial NCT05266729: Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Moderate or Severe Submental Fullness
Lead sponsor: AMIpharm Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 96
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 severe convexity or fullness associated with SMF in adults.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: 4 weeks after the final treatment
Secondary outcomes:
measure: 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)
timeFrame: 12 weeks after the final treatment
measure: Percentage of subjects who improved at least 1 grade of Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS)
timeFrame: 4 and 12 weeks after the final treatment
measure: Percentage of subjects who improved at least 1 grade of Subject-Reported Submental Fat Rating Scale (SR-SMFRS)
timeFrame: 4 and 12 weeks after the final treatment
measure: Volume difference of pre-platysmal submental fat around chin area
timeFrame: 4 weeks after the final treatment
measure: Volume difference of platysmal submental fat around chin area
timeFrame: 4 weeks after the final treatment
measure: 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)
timeFrame: 4 and 12 weeks after the final treatment
measure: Difference of Subject Self Satisfaction Scale (SSSS)
timeFrame: 4 and 12 weeks after the final treatment
measure: Difference of Patient-Reported Submental Fat Impact Scale (PR-SMFIS) score
timeFrame: 4 and 12 weeks after the final treatment
measure: Difference of volume of submental fat around chin area analyzed with 3D
timeFrame: 4 weeks after the final treatment
measure: Patient Global Impression of Change scale (PGIC)
timeFrame: 4 weeks after the final treatment
measure: Difference of Derriford Appearance Scale 24 (DAS24)
timeFrame: 4 weeks after the final treatment
measure: Difference of Body Image Quality Life Inventory (BIQLI) score
timeFrame: 4 weeks after the final treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung Ang University Hospital
Study officials:
References: