Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm | Experimental | Participants receive 2.5% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
|
| 5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm | Experimental | Participants receive 5.0% polyene phosphatidylcholine administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
|
| 5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm | Experimental | Participants receive 5.0% polyene phosphatidylcholine administered in 0.4 mL injections, 1.0 cm apart, up to 20.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
|
| Placebo 0.2 mL/1.0 cm | Placebo Comparator | Participants receive placebo administered in 0.2 mL injections, 1.0 cm apart, up to 10.0 ml per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyene phosphatidylcholine injection | Drug | Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12 weeks after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dae Hyeon Lew, MD,PhD | Yonsei University Health System, Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 13620 | South Korea | ||
| Yonsei University Health System, Severance Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | Phosphate buffered saline placebo for injection |
|
| 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. | 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. | Baseline and 12 weeks after last treatment |
| Change From Baseline in a Magnetic Resonance Imaging (MRI) Response in Platysmal Area | Change rate of reduction in platysmal volume. | 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. | 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. | 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). | 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. | 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. | 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). | 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). | Baseline and 12 weeks after last treatment |
| Seoul |
| 03722 |
| South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Yonsei University Health System, Gangnam Severance Hospital | Seoul | 06273 | South Korea |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C029449 | polyene phosphatidylcholine |
Not provided
Not provided
Not provided