Treatment for Submental Fat
Conditions
Brief summary
evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
Detailed description
DWJ211 \_ reduction of moderate or severe submental fat
Interventions
DRUGDWJ211
inject the Drug into submental fat via subcutaneous
DRUGNormal saline
inject the Drug into submental fat via subcutaneous
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. submental fat grade by the investigator as 2 or 3 using the PA-SMFRS and graded by the subject as 2 or 3 using the SA-SMFRS as determined on Visit 1. 2. Dissatisfaction with the submental area expressed by the subject as a rating of 1\ 3 using the SSS as determinded on Visit 1. 3. less than 35kg/m2 in body mass index on Visit1. 4. subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat. 5. subject who will agree with maintaining their body weight.
Exclusion criteria
1. History of any intervention to treat SMF 2. History of trauma associated with the chin or neck areas that in the judgement of the investigator may affect evaluation of safety or efficacy of treatment. 3. Evidence of any cause of enlargement in the submental area. 4. history or current symptoms of dysphagia. 5. a result on coagulation tests that indicates the presence of any clinically significant bleeding disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-grade response : SA-SMFRS | 4 week after last treatment | proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment |
| 2-grade response : PA-SMFRS | 4 week after last treatment | proportion of subject who simultaneously have at least a 2 grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment |
| 2-grade response : SA-SMFRS | 4 week after last treatment | proportion of subject who simultaneously have at least a 2-grade improvement from baseline on the SA-SMFRS at 4weeks after the last treatment |
| 1-grade response : PA-SMFRS | 4 week after last treatment | proportion of subject who simultaneously have at least a 1-grade improvement from baseline on the PA-SMFRS at 4weeks after the last treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRI volume response rate | 4 week after last treatment | change rate of reduction in SMF volume |
| improvement: SA-SMFIS | 4 week after last treatment | improvement in the Subject reported submental fat impact scale overall score |
| obtained 5 score : SSS | 4 week after last treatment | proportion of subjects who have more than 5 score on the SSS(somewhat satisfied) |
| thickness response rate : caliper | 4 week after last treatment | change rate of reduction in SMF volume |
Countries
South Korea
Outcome results
None listed