An Open-Label Study to Evaluate Retreatment With LIPO-202
This trial is active, not recruiting.
|Condition||central abdominal bulging|
|Start date||March 2015|
|End date||June 2016|
|Trial size||150 participants|
|Trial identifier||NCT02397525, LIPO-202-CL-22|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Englewood, CO||AboutSkin Dermatology||no longer recruiting|
|Coral Gables, FL||Dermatology Research Institute, LLC||no longer recruiting|
|Snellville, GA||Gwinnett Clinical Research Center, Inc||no longer recruiting|
|New Orleans, LA||Lupo Center for Aesthetic and General Dermatology||no longer recruiting|
|New York, NY||Bass Plastic Surgery PLLC||no longer recruiting|
|Stony Brook, NY||DermResearch Center of New York||no longer recruiting|
|San Antonio, TX||Dermatology Clinical Research Center of San Antonio||no longer recruiting|
|Charlottesville, VA||Charlottesville Medical Research||no longer recruiting|
|Intervention model||single group assignment|
Safety: vital signs, physical exams, laboratory tests
time frame: 12 months
Male or female participants at least 18 years old.
- 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
|Official title||An Open-Label Study to Evaluate Retreatment With LIPO-202|
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