Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduc… (NCT03982225) | Clinical Trial Compass
CompletedPhase 2
Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat
South Korea143 participantsStarted 2019-07-01
Plain-language summary
Phase 2 trial to evaluate the safety and potential efficacy of three concentration of polyene phosphatidylcholine injection (AYP-101) compared to placebo for the reduction of submental fat.
Who can participate
Age range19 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male and female over 19 and under 65 years old.
✓. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and graded by the subject as 2 or 3 using the Patient-Reported Submental Fat Rating Scale (PR-SMFRS) as determined on Visit 1.
✓. Dissatisfaction with the submental area expressed by the subject as a rating of 0, 1, or 2 using the Subject Self Rating Scale (SSRS) as determined on Visit 1.
✓. 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.
✓. Signed informed consent obtained before any study-specific procedure is performed.
Exclusion criteria
✕. Allergic to beans or medical devices which used in this clinical trial (sterile oil pan, alcohol swab, grid pad, needle, etc.).
✕. Hypersensitivity to the components of the clinical drug, lidocaine or acetaminophen.
✕. Central, endocrine, or hereditary obesity (BMI 35kg/m2 or more).
✕. Unable to undergo MRI by neurosis or general weakness.
✕. History of any treatment (orthognathic surgery, suction lipectomy, Polyene Phosphatidylcholine (PPC) injection) in the neck or chin area.
✕. History of any treatment such as massotherapy, carboxy, laser surgery, acupuncture needle, filler, chemical peeling, a botox surgery within 1 year before screening.
What they're measuring
1
Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
Timeframe: Baseline and 12 weeks after last treatment
✕. Inflammation, scars or surgery on the injection area.
✕. Judged to be unsuitable subject for the clinical trials; ①Abnormal or sagging skin, ② Noticeable platysma band under the chin area, ③ Less or short chin than normal.