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evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
DWJ211
_ reduction of moderate or severe submental fat
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | SQ injection |
|
| DWJ211_0.5% | Experimental | SQ injection with DWJ211 0.5% |
|
| DWJ211_1% | Experimental | SQ injection with DWJ211 1.0% |
|
| DWJ211_2% | Experimental | SQ injection with DWJ211 2.0% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ211 | Drug | inject the Drug into submental fat via subcutaneous |
|
| Measure | Description | Time Frame |
|---|---|---|
| 2-grade response : PA-SMFRS | proportion of subject who simultaneously have at least a 2 grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment | 4 week after last treatment |
| 2-grade response : SA-SMFRS | proportion of subject who simultaneously have at least a 2-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment | 4 week after last treatment |
| 1-grade response : PA-SMFRS | proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment | 4 week after last treatment |
| 1-grade response : SA-SMFRS | proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment | 4 week after last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| MRI volume response rate | change rate of reduction in SMF volume | 4 week after last treatment |
| improvement: SA-SMFIS | improvement in the Subject reported submental fat impact scale overall score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beom Joon Kim, MD, PhD | Chung-Ang University Hospital | Study Chair |
| Yang-won Lee, MD, PhD | Konkuk University Medical Center | Principal Investigator |
| Chong-hyun Won, MD, PhD | Seoul Asan medical center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chung-ang university hospital | Seoul | South Korea | ||||
| Konkuk university medical center |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Normal saline | Drug | inject the Drug into submental fat via subcutaneous |
|
| 4 week after last treatment |
| obtained 5 score : SSS | proportion of subjects who have more than 5 score on the SSS(somewhat satisfied) | 4 week after last treatment |
| thickness response rate : caliper | change rate of reduction in SMF volume | 4 week after last treatment |
| Seoul |
| South Korea |
| Seoul Asan medical center | Seoul | South Korea |