Clinical trial NCT01802723: Dose Ranging Study
Official title: A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Periumbilical Subcutaneous Adipose Tissue Reduction
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 472
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dose Ranging Study


Eligibility criteria: Inclusion Criteria:

\>18 years of age inclusive Subcutaneous fat in the periumbilical area BMI \<30 kg/msq Stable diet and exercise and body weight

Exclusion Criteria:

Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs

Primary outcomes:
measure: Safety
timeFrame: 8 weeks treatment
measure: Change in global clinician abdominal perception scale score (baseline and 9 weeks)
timeFrame: 9 weeks
measure: Change in global patient abdominal perception scale score (baseline and 9 weeks)
timeFrame: 9 weeks
measure: Change in abdominal circumference (baseline and 9 weeks)
timeFrame: 9 weeks
Secondary outcomes:
measure: Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)
timeFrame: 9 weeks
measure: Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)
timeFrame: 9 weeks
Other outcomes:
measure: Change in subcutaneous abdominal adipose tissue thickness (baseline and 9 weeks)
timeFrame: 9 weeks
Locations:
city: Beverly Hills
country: United States
facility: United States, California
state: California
city: Encinitas
country: United States
facility: United States, California
state: California
city: Los Angeles
country: United States
facility: United States, California
state: California
city: San Diego
country: United States
facility: United States, California
state: California
city: Santa Ana
country: United States
facility: United States, California
state: California
city: Aventura
country: United States
facility: United States, Florida
state: Florida
city: Clearwater
country: United States
facility: United States, Florida
state: Florida
city: Lake Worth
country: United States
facility: United States, Florida
state: Florida
city: Miami
country: United States
facility: United States, Florida
state: Florida
city: Tampa
country: United States
facility: United States, Florida
state: Florida
city: Buffalo Grove
country: United States
facility: United States, Illinois
state: Illinois
city: Chicago
country: United States
facility: United States, Illinois
state: Illinois
city: New York
country: United States
facility: United States, New York
state: New York
city: Smithtown
country: United States
facility: United States, New York
state: New York
city: Chapel Hill
country: United States
facility: United States, North Carolina
state: North Carolina
city: Raleigh
country: United States
facility: United States, North Carolina
state: North Carolina
city: Nashville
country: United States
facility: United States, Tennessee
state: Tennessee
city: Austin
country: United States
facility: United States, Texas
state: Texas
city: Dallas
country: United States
facility: United States, Texas
state: Texas
city: Fort Worth
country: United States
facility: United States, Texas
state: Texas
city: Houston
country: United States
facility: United States, Texas
state: Texas
city: Plano
country: United States
facility: United States, Texas
state: Texas
Study officials:
affiliation: Neothetics, Inc
name: Murray C Maytom, MBChB, MBA
role: STUDY_DIRECTOR
References: