A Randomized, Double-blind, Multi-center, Placebo-controlled, Dose Finding Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat

DW_DWJ211001

evaluate the efficacy and safety of DWJ211 in patient with moderate or severe submental fat

2017-10-26

2018-06-29

2018-06-29

Completed

Early phase I

140

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 140, 'type': 'ACTUAL'}}

2024-04-04