| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Moderate or Severe Submental Fullness | Drug: Polyene phosphatidylcholine injection Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 140 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Subject-assessor Blind, Placebo Controlled Phase Ⅱ Study to Determine the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat |
| Actual Study Start Date : | July 1, 2019 |
| Estimated Primary Completion Date : | June 30, 2021 |
| Estimated Study Completion Date : | July 31, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 2.5% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm
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.
|
Drug: Polyene phosphatidylcholine injection
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
Other Name: AYP-101
|
|
Experimental: 5.0% Polyene Phosphatidylcholine Injection 0.2 mL/1.0 cm
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.
|
Drug: Polyene phosphatidylcholine injection
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
Other Name: AYP-101
|
|
Experimental: 5.0% Polyene Phosphatidylcholine Injection 0.4 mL/1.0 cm
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.
|
Drug: Polyene phosphatidylcholine injection
Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
Other Name: AYP-101
|
|
Placebo Comparator: Placebo 0.2 mL/1.0 cm
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.
|
Drug: Placebo
Phosphate buffered saline placebo for injection
|
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.
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.
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.
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.
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.
| Ages Eligible for Study: | 19 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Ki Taek Lee | +82-2-3473-1830 | amikt@amipharm.com | |
| Contact: Ji Hyun Park | +82-2-3473-1830 | amijh@amipharm.com |
| Korea, Republic of | |
| Seoul National University Bundang Hospital | Recruiting |
| Seongnam, Gyeonggi, Korea, Republic of, 13620 | |
| Yonsei University Health System, Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 03722 | |
| Asan Medical Center | Recruiting |
| Seoul, Korea, Republic of, 05505 | |
| Yonsei University Health System, Gangnam Severance Hospital | Recruiting |
| Seoul, Korea, Republic of, 06273 | |
| Principal Investigator: | Dae Hyeon Lew, MD,PhD | Yonsei University Health System, Severance Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 5, 2019 | ||||||||
| First Posted Date ICMJE | June 11, 2019 | ||||||||
| Last Update Posted Date | June 5, 2020 | ||||||||
| Actual Study Start Date ICMJE | July 1, 2019 | ||||||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 [ Time Frame: Baseline and 12 weeks after last treatment ] 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.
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluate the Efficacy and Safety of Polyene Phosphatidylcholine Injection (AYP-101) for the Reduction of Submental Fat | ||||||||
| Official Title ICMJE | A Multicenter, Randomized, Subject-assessor Blind, Placebo Controlled Phase Ⅱ Study to Determine the Optimal Dose of AYP-101 S.C. Injection for the Reduction of Submental Fat | ||||||||
| Brief Summary | 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. | ||||||||
| Detailed Description | 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 ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
||||||||
| Condition ICMJE | Moderate or Severe Submental Fullness | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
140 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | July 31, 2021 | ||||||||
| Estimated Primary Completion Date | June 30, 2021 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 19 Years to 65 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||||
| Contacts ICMJE |
|
||||||||
| Listed Location Countries ICMJE | Korea, Republic of | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03982225 | ||||||||
| Other Study ID Numbers ICMJE | AYP-101 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement ICMJE |
|
||||||||
| Responsible Party | AMIpharm Co., Ltd. | ||||||||
| Study Sponsor ICMJE | AMIpharm Co., Ltd. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| PRS Account | AMIpharm Co., Ltd. | ||||||||
| Verification Date | January 2020 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||