An Open-Label Study to Evaluate Retreatment With LIPO-202
- Registration Number
- NCT02397525
- Lead Sponsor
- Neothetics, Inc
- Brief Summary
Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Provided consent
- Healthy male or non-pregnant female subjects
- BMI < 30 kg/m2
- Stable diet and exercise routine
- Central abdominal bulging that is 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.
- Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
- Known hypersensitivity to study drugs
- Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LIPO-202 LIPO-202 -
- Primary Outcome Measures
Name Time Method Safety: vital signs, physical exams, laboratory tests 12 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
AboutSkin Dermatology
🇺🇸Englewood, Colorado, United States
Dermatology Research Institute, LLC
🇺🇸Coral Gables, Florida, United States
Gwinnett Clinical Research Center, Inc
🇺🇸Snellville, Georgia, United States
Lupo Center for Aesthetic and General Dermatology
🇺🇸New Orleans, Louisiana, United States
Bass Plastic Surgery PLLC
🇺🇸New York, New York, United States
DermResearch Center of New York
🇺🇸Stony Brook, New York, United States
Dermatology Clinical Research Center of San Antonio
🇺🇸San Antonio, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
AboutSkin Dermatology🇺🇸Englewood, Colorado, United States