Clinical trial NCT02397499: Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat
Official title: A Multi-Center, Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat in Non-Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Abdominal Bulging
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2015-03-25
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, randomized, double-blinded, placebo-controlled study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat in non-obese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female subjects
* Capable of providing written consent.
* BMI \< 30 kg/m2
* Stable diet and exercise routine
* Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat

Exclusion Criteria:

* Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
* Plan on starting a weight loss or exercise program during the study.
* Known hypersensitivity to study drugs

Primary outcomes:
measure: Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests.
timeFrame: 8 weeks
measure: Change in the clinician reported photonumeric score
timeFrame: 8 weeks post the start of treatment
measure: Change in the patient reported global abdominal perception score
timeFrame: 8 weeks post the start of treatment
Secondary outcomes:
measure: Change in waist circumference
timeFrame: 8 weeks post the start of treatment
Other outcomes:
Locations:
city: Tucson
country: United States
facility: WG Clinical Research
state: Arizona
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Beverly Hills
country: United States
facility: Clinical Testing Center of Beverly Hills
state: California
city: Fremont
country: United States
facility: Center for Dermatology Cosmetic and Laser Surgery
state: California
city: San Diego
country: United States
facility: Dermatology/Cosmetic Laser Associates of La Jolla, Inc
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Aventura
country: United States
facility: The Center for Clinical & Cosmetic Research
state: Florida
city: Boca Raton
country: United States
facility: Skin Care Research, Inc.
state: Florida
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Clinical Research of South Florida
state: Florida
city: Miami
country: United States
facility: International Dermatology Research
state: Florida
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: Louisville
country: United States
facility: Dermatology Specialists Research
state: Kentucky
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
city: Hackensack
country: United States
facility: Skin Laser & Surgery Specialist of NY/NJ
state: New Jersey
city: New York
country: United States
facility: Juva Skin & Laser Center
state: New York
city: New York
country: United States
facility: Skin Specialty Dermatology
state: New York
city: Smithtown
country: United States
facility: Marina I Peredo, M.D, P.C.
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions
state: North Carolina
city: Charlotte
country: United States
facility: Dermatology, Laser and Vein Specialists of the Carolinas
state: North Carolina
city: Austin
country: United States
facility: Westlake Dermatology Clinical Research Center
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Menter Dermatology Research Center
state: Texas
city: Katy
country: United States
facility: Suzanne Bruce and Associates, P.A., The Center for Skin Research
state: Texas
city: Plano
country: United States
facility: Research Across America
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
Study officials:
affiliation: Neothetics, Inc
name: Maria Feldman
role: STUDY_DIRECTOR
References: