Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on submental bulging due to subcutaneous fat. Approximately 150 participants of either gender who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported Submental Bulging Scale \[PR-SBS\] and Clinician-Reported Submental Bulging Scale \[CR-SBS\]) will be recruited for this study.
Potential subjects will present and complete the Screening Visit. All qualifying subjects will be randomized to one of three treatment groups and treated with up to 30 subcutaneous injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon completion of treatment visits, subject will return to the clinic for a follow-up visit and end of study visit, one and four weeks after the last treatment. The number and pattern of injections will be based on the area (cm x cm) of submental fat at baseline. At each visit the subjects will also undergo an examination of the treatment area, collection of vital signs and questioning about possible adverse events (AEs). The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit and an End of Study Visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
162
Lyophile manufactured to mimic LIPO-202 lyophile.
Clinical Testing of Beverly Hills
Beverly Hills, California, United States
Ablon Skin Institute And Research Center
Manhattan Beach, California, United States
AboutSkin Research
Greenwood Village, Colorado, United States
Safety as measured by number of subjects with adverse events.
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results.
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
Change from baseline in the patient reported submental bulging scale.
The self-rating scale is 5-point scale that the subject evaluates their submental fat.
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
Change from baseline in the clinician reported submental bulging scale
The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
Change in submental fat thickness measured with calipers (mm).
Time frame: 12 weeks (Baseline through 4 weeks post last dose)
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Skin Research Institute
Coral Gables, Florida, United States
Grekin Skin Institute
Warren, Michigan, United States
Minnesota Clinical Study Center
Fridley, Minnesota, United States
Mercy Research
Washington, Missouri, United States
Skin Specialists, PC
Omaha, Nebraska, United States
Juva Skin & Laser Center
New York, New York, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
...and 1 more locations