Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in C… (NCT05266729) | Clinical Trial Compass
CompletedPhase 2
Determine the Dosing Interval and Optimal Dose of AYP-101 for the Reduction of Submental Fat in Chin Area
South Korea96 participantsStarted 2022-03-02
Plain-language 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).
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
* Localized submental fat under chin area and who meet all the following criteria.
â‘ Determined as grade 2 (moderate) or 3 (severe) on both using the CR-SMFRS and PR-SMFRS at visit 1
â‘¡ 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; â‘ Abnormal or sagging skin, â‘¡ Noticeable platysma band under the chin area, â‘¢ Less or short chin than normal â‘£ 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 …
What they're measuring
1
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)