KCT0004034
Recruiting
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 sites140 target enrollmentTBD
ConditionsNot Applicable
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not Applicable
- Sponsor
- Amipharm
- Enrollment
- 140
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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