Clinical trial NCT03224117: Clinicial Trial to Evaluate the Efficacy and Safety of DWJ211 in Patient With Moderate or Severe Submental Fat
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Treatment for Submental Fat
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2017-07-21
Enrollment: 140
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: 2-grade response : PA-SMFRS
timeFrame: 4 week after last treatment
measure: 2-grade response : SA-SMFRS
timeFrame: 4 week after last treatment
measure: 1-grade response : PA-SMFRS
timeFrame: 4 week after last treatment
measure: 1-grade response : SA-SMFRS
timeFrame: 4 week after last treatment
Secondary outcomes:
measure: MRI volume response rate
timeFrame: 4 week after last treatment
measure: improvement: SA-SMFIS
timeFrame: 4 week after last treatment
measure: obtained 5 score : SSS
timeFrame: 4 week after last treatment
measure: thickness response rate : caliper
timeFrame: 4 week after last treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Chung-ang university hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk university medical center
city: Seoul
country: Korea, Republic of
facility: Seoul Asan medical center
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Beom Joon Kim, MD, PhD
role: STUDY_CHAIR
affiliation: Konkuk University Medical Center
name: Yang-won Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul Asan medical center
name: Chong-hyun Won, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: