To Evaluate Efficacy and Safety of AYP-101 S.C injection for the Reduction of Submental Fat in Adults
This study is to evaluate efficacy and safety of AYP-101 S.C injection for the reduction of Submental Fat who wish improvement in the appearance of moderate to severe convexity or fullness associated with Submental Fat in adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
Formulated as an injectable solution containing Polyene Phosphatidylcholine at concentration of 25 mg/mL
Phosphate buffered saline placebo for injection
Chung-Ang University Hosptial
Seoul, South Korea
Co-primary Outcome Measure 1
Ratio of subjects with at least 1 grade improvement in both ER-SMFRS(Evaluator Reported Submental Fat Rating Scale) and SR-SMFRS(Subject Reported Submental Fat Rating Scale)
Time frame: at 12 weeks after the final administration compared to baseline
Co-primary Outcome Measure 2
Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS
Time frame: at 12 weeks after the final administration compared to baseline
At least 1 grade improvement in both ER-SMFRS and SR-SMFRS
Ratio of subjects with at least 1 grade improvement in both ER-SMFRS and SR-SMFRS
Time frame: at 4 weeks after the final administration compared to baseline
At least 2 grade improvement in both ER-SMFRS and SR-SMFRS
Ratio of subjects with at least 2 grades improvement in both ER-SMFRS and SR-SMFRS
Time frame: at 4 weeks after the final administration compared to baseline
At least 1 grade improvement in ER-SMFRS
Ratio of subjects with at least 1 grade improvement in ER-SMFRS
Time frame: at 4 and 12 weeks after the final administration compared to baseline
At least 2 grades improvement in ER-SMFRS
Ratio of subjects with at least 2 grades improvement in ER-SMFRS
Time frame: at 4 and 12 weeks after the final administration compared to baseline
At least 1 grade improvement in SR-SMFRS
Ratio of subjects with at least 1 grade improvement in SR-SMFRS
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Time frame: at 4 and 12 weeks after the final administration compared to baseline
At least 2 grades improvement in SR-SMFRS
Ratio of subjects with at least 2 grades improvement in SR-SMFRS
Time frame: at 4 and 12 weeks after the final administration compared to baseline
SSSS(Subject Self Satisfaction Scale)
Ratio of subjects with SSSS of at least 4 points
Time frame: at 4 and 12 weeks after the final administration
PR-SMFIS(Patient Reported Submental Fat Impact Scale)
Change in average PR-SMFIS score from baseline, In detail, it is a tool on which subjects measure how their submental fat looks on a scale of 0 to 10 points b y responding to 6 questions. Item 1 is in regard to satisfaction, and items 2 to 6 are questions in regard to dissatisfaction; all items will be calculated on a dissatisfaction scale\* and mean will be calculated. * Item 1 dissatisfaction scale = 10 (points) - Item 1 score * Items 2 to 6 dissatisfaction scale = each item score Each item in the PR-SMFIS is scored from 0 to 10, with a higher total score indicating greater dissatisfaction.
Time frame: at 4 and 12 weeks after the final administration
PGIC(Patient Global Impression of Change)
PGIC evaluation
Time frame: at 4 and 12 weeks after the final administration
3D imaging
Change in subject's submental fat volume by 3D imaging from baseline
Time frame: at 4 and 12 weeks after the final administration