Submental Fat Clinical Trial
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of LIPO-202 (Salmeterol Xinafoate for Injection) for the Reduction of Submental Subcutaneous Fat
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. ;
|Start date||December 22, 2016|
|Completion date||June 2, 2017|
|Active, not recruiting||