Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat
- Registration Number
- NCT02397499
- Lead Sponsor
- Neothetics, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 800
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo comparator LIPO-202 LIPO-202 Experimental arm
- Primary Outcome Measures
Name Time Method Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests. 8 weeks Physical examination, adverse events, vital signs, and laboratory tests.
Change in the clinician reported photonumeric score 8 weeks post the start of treatment Change in the patient reported global abdominal perception score 8 weeks post the start of treatment
- Secondary Outcome Measures
Name Time Method Change in waist circumference 8 weeks post the start of treatment
Trial Locations
- Locations (31)
Skin Care Research, Inc.
🇺🇸Boca Raton, Florida, United States
Clinical Testing Center of Beverly Hills
🇺🇸Beverly Hills, California, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Center for Dermatology Cosmetic and Laser Surgery
🇺🇸Fremont, California, United States
The Center for Clinical & Cosmetic Research
🇺🇸Aventura, Florida, United States
Altman Dermatology Associates
🇺🇸Arlington Heights, Illinois, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
Clinical Research of West Florida, Inc.
🇺🇸Clearwater, Florida, United States
Glazer Dermatology
🇺🇸Buffalo Grove, Illinois, United States
Grekin Skin Institute
🇺🇸Warren, Michigan, United States
Minnesota Clinical Study Center
🇺🇸Fridley, Minnesota, United States
Juva Skin & Laser Center
🇺🇸New York, New York, United States
Skin Laser & Surgery Specialist of NY/NJ
🇺🇸Hackensack, New Jersey, United States
Marina I Peredo, M.D, P.C.
🇺🇸Smithtown, New York, United States
Skin Specialty Dermatology
🇺🇸New York, New York, United States
Dermatology, Laser and Vein Specialists of the Carolinas
🇺🇸Charlotte, North Carolina, United States
J & S Studies, Inc.
🇺🇸College Station, Texas, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research
🇺🇸Katy, Texas, United States
Menter Dermatology Research Center
🇺🇸Dallas, Texas, United States
Research Across America
🇺🇸Plano, Texas, United States
Virginia Clinical Research, Inc.
🇺🇸Norfolk, Virginia, United States
WG Clinical Research
🇺🇸Tucson, Arizona, United States
Burke Pharmaceutical Research
🇺🇸Hot Springs, Arkansas, United States
Dermatology/Cosmetic Laser Associates of La Jolla, Inc
🇺🇸San Diego, California, United States
University Clinical Trials, Inc.
🇺🇸San Diego, California, United States
International Dermatology Research
🇺🇸Miami, Florida, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Dermatology Research Center, Inc.
🇺🇸Salt Lake City, Utah, United States
Dermatology Specialists Research
🇺🇸Louisville, Kentucky, United States
Aesthetic Solutions
🇺🇸Chapel Hill, North Carolina, United States
Westlake Dermatology Clinical Research Center
🇺🇸Austin, Texas, United States