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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
793
Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response
The composite P-GAPS1/CPnS2 response was defined as at least a 1 point (grade) improvement in P-GAPS and at least a 2 point (grade) improvement in CPnS from baseline after 8 weeks of treatment. Patient - Global Abdominal Perception Scale (P-GAPS) - a patient views and assesses the contour of their abdomen on a 5-point verbal scale ranging from "Flat" to "Big Bulge". Clinician Photonumeric Scale (CPnS) - a trained clinician rater examines the subject's abdomen and matches the subject's abdominal bulge/profile to the nearest gender-specific abdominal photo on the 6-point scale.
Time frame: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)
Percent Change in the Patient Reported Global Abdominal Perception Score
1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.
Time frame: 8 weeks post the start of treatment
Percent Change in Waist Circumference
Time frame: 8 weeks post the start of treatment
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