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.
This study is to determine the optimal dose and evaluate safety and efficacy of Polyene Phosphatidylcholine S.C injection (AYP-101) for the reduction of Submental Fat (SMF) who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
143
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
Phosphate buffered saline placebo for injection
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Yonsei University Health System, Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Yonsei University Health System, Gangnam Severance Hospital
Seoul, South Korea
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
A composite 1-grade response is defined as at least a 1-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Time frame: Baseline and 12 weeks after last treatment
Percentage of Participants Who Achieved a Composite 1-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Compared to the Baseline
The CR-SMFRS is defined as at least a 1-grade improvement is evaluated by independent assessor from Baseline using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Time frame: Baseline and 12 weeks after last treatment
Percentage of Participants Who Achieved a Composite 1-grade Response with Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4): 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Pre-platysmal Area
Change rate of reduction in pre-platysmal volume.
Time frame: Baseline and 12 weeks after last treatment
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Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area
Change rate of reduction in platysmal volume.
Time frame: Baseline and 12 weeks after last treatment
Percentage of Participants Who Achieved a Composite 2-grade Response with Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Compared to the Baseline
A composite 2-grade response is defined as at least a 2-grade improvement from Baseline on both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) is evaluated by independent assessor and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) using the following scale: 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat.
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in Participants With a Subject Self Rating Scale (SSRS) Response
A SSRS response is defined as an SSRS score that is 4 or greater 12 weeks after the last treatment. The SSRS assesses participant's satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6: where 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)
Patients are asked to rate the visual and emotional impact that the appearance of submental fullness had on their self-perception using 11-point scale range from 0 (no impact) to 10 (extreme impact).
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in Depth of Cervical Mental Angle Analyzed with 3D Scanner
The cervical mental angle is measured using a 3D scanner photograph obtained at first and last visit.
Time frame: Baseline and 12 weeks after last treatment
Patient Global Impression of Change scale (PGIC)
Patient global impression of change scale (PGIC) is to rate patients total improvement or worsening in the appearance since before the first treatment compared to final treatment with 1 = Very much improved, 2 = Much improved, 3 = Minimally improved, 4 = No change, 5 = Minimally worse, 6 = Much worse, 7 = Very much worse.
Time frame: 12 weeks after last treatment
Change From Baseline in Derriford Appearance Scale 24 (DAS24)
Difference of Derriford Appearance Scale 24 (DAS24) is to measure distress and dysfunction to problems of appearance with 24 questions using 4-point from 0 (None) to 4 (more distress).
Time frame: Baseline and 12 weeks after last treatment
Change From Baseline in Body Image Quality of Life Inventory (BIQLI)
Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7-point ranging from -3 (very negative) to +3 (very positive).
Time frame: Baseline and 12 weeks after last treatment