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
Overview
- Phase
- Phase 3
- Intervention
- LIPO-202
- Conditions
- Central Abdominal Bulging
- Sponsor
- Evofem Inc.
- Enrollment
- 793
- Locations
- 35
- Primary Endpoint
- Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or non-pregnant female subjects
- •Capable of providing written consent.
- •BMI \< 30 kg/m2
- •Stable diet and exercise routine
- •Central abdominal bulging that is evaluated by the clinician at least slight bulge, not flat
Exclusion Criteria
- •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.
- •Known hypersensitivity to study drugs
Arms & Interventions
LIPO-202
Experimental arm
Intervention: LIPO-202
Placebo
Placebo comparator
Intervention: Placebo
Outcomes
Primary Outcomes
Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response
Time Frame: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)
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.
Percent Change in the Patient Reported Global Abdominal Perception Score
Time Frame: 8 weeks post the start of treatment
1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.
Secondary Outcomes
- Percent Change in Waist Circumference(8 weeks post the start of treatment)