Submental Fat Clinical Trial
— SMFOfficial title:
A Randomized, Double-blind, Multi-center, Placebo-controlled, Phase Ⅲ Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
| Verified date | April 2024 |
| Source | Daewoong Pharmaceutical Co. LTD. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat
| Status | Completed |
| Enrollment | 148 |
| Est. completion date | July 2, 2020 |
| Est. primary completion date | July 2, 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 19 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Chung-ang university hospital | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Daewoong Pharmaceutical Co. LTD. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PA-SMFRS, SA-SMFRS | 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 | 12 week after last treatment |
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