A Phase 2 interventional study of Polyene Phosphatidylcholine and Placebo in Moderate or Severe Submental Fullness, sponsored by AMIpharm Co., Ltd.. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-15.
Sponsored by AMIpharm Co., Ltd. · Phase 2, Interventional, and Treatment
To determine the dosing interval, optimal dose, evaluate safety, and efficacy of AYP-101 S.C injection for the reduction of Submental Fat (SMF).
This study is to determine the dosing interval, optimal dose, evaluate safety and efficacy of AYP-101 S.C injection for the reduction of SMF who wish improvement in the appearance of moderate to severe convexity or fullness associated with SMF in adults.
AMIpharm Co., Ltd. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Localized submental fat under chin area and who meet all the following criteria.
① Determined as grade 2 (moderate) or 3 (severe) on both using the CR-SMFRS and PR-SMFRS at visit 1
② Determined as grade 2 (less satisfied) or less by oneself, using the SSRS at visit 1
Exclusion Criteria:
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
Drug: Polyene Phosphatidylcholine
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
Drug: Polyene Phosphatidylcholine
0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 2 weeks for up to a maximum of 6 treatments.
Drug: Placebo
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
Also known as: AYP-101
Phosphate buffered saline placebo for injection
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)
Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Time frame: 4 weeks after the final treatment
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 (SR-SMFRS)
Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Time frame: 12 weeks after the final treatment
Percentage of subjects who improved at least 1 grade of Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS)
Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Time frame: 4 and 12 weeks after the final treatment
Percentage of subjects who improved at least 1 grade of Subject-Reported Submental Fat Rating Scale (SR-SMFRS)
Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Time frame: 4 and 12 weeks after the final treatment
Volume difference of pre-platysmal submental fat around chin area
Volume of pre-platysmal submental fat around chin area was measured using MRI
Time frame: 4 weeks after the final treatment
Volume difference of platysmal submental fat around chin area
Volume of platysmal submental fat around chin area was measured using MRI
Time frame: 4 weeks after the final treatment
Percentage of subjects who improved at least 2 grades in both Evaluator-Reported Submental Fat Rating Scale (ER-SMFRS) and Subject-Reported Submental Fat Rating Scale (SR-SMFRS)
Submental Fat Rating Scale is scored on a 5-point scale with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme.
Time frame: 4 and 12 weeks after the final treatment
Difference of Subject Self Satisfaction Scale (SSSS)
Subject Self Satisfaction Scale (SSSS) assesses participants' satisfaction with their appearance in association with the face and chin on a 7-point scale from 0 to 6 with 0 = Extremely dissatisfied, 1 = Dissatisfied, 2 = Slightly dissatisfied, 3 = Neither satisfied nor dissatisfied, 4 = Slightly satisfied, 5 = Satisfied and 6 = Extremely satisfied.
Time frame: 4 and 12 weeks after the final treatment
Difference of Patient-Reported Submental Fat Impact Scale (PR-SMFIS) score
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: 4 and 12 weeks after the final treatment
Difference of volume of submental fat around chin area analyzed with 3D
Volume of submental fat around chin area is measured using a 3D scanner photograph
Time frame: 4 weeks after the final 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: 4 weeks after the final treatment
Difference of Derriford Appearance Scale 24 (DAS24)
Difference of Derriford Appearance Scale 24 (DAS24) score is to measure distress and dysfunction to problems of appearance with 24 item scale.
Time frame: 4 weeks after the final treatment
Difference of Body Image Quality Life Inventory (BIQLI) score
Body Image Quality Life Inventory (BIQLI) assesses participants' body image using 7 point ranging from -3 (very negative) to +3 (very positive).
Time frame: 4 weeks after the final treatment
Plan to share: No
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AMIpharm Co., Ltd.