Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
- Registration Number
- NCT03946592
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
- Detailed Description
DWJ211 is a injectable drug for improvement in the appearance of moderate to severe submental fat (SMF)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 148
Inclusion Criteria
- 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.
- Dissatisfaction with the submental area expressed by the subject as a rating of 1~3 using the SSS as determinded on Visit 1.
- Less than 35kg/m2 in body mass index on Visit1.
- Subject who will agree with the no treatment for the procedure that may affect to reduction or the submental fat.
Exclusion Criteria
- History of any intervention to treat SMF
- 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.
- Evidence of any cause of enlargement in the submental area.
- History or current symptoms of dysphagia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo group Normal saline Inject the Drug into submental fat via subcutaneous DWJ211 group DWJ211 Inject the Drug into submental fat via subcutaneous
- Primary Outcome Measures
Name Time Method PA-SMFRS, SA-SMFRS 12 week after last treatment Proportion of subject who simultaneously have at least a 1 grade, 2grade improvement from baseline on the PA-SMFRS, SA-SMFRS after the last treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chung-ang university hospital
🇰🇷Seoul, Korea, Republic of