Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
- Registration Number
- NCT02398188
- Lead Sponsor
- Evofem Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 793
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LIPO-202 LIPO-202 Experimental arm Placebo Placebo Placebo comparator
- Primary Outcome Measures
Name Time Method Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response 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 8 weeks post the start of treatment 1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.
- Secondary Outcome Measures
Name Time Method Percent Change in Waist Circumference 8 weeks post the start of treatment
Trial Locations
- Locations (35)
Society Hill Dermatology
🇺🇸Philadelphia, Pennsylvania, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Zel Skin & Laser Specialist, LLC
🇺🇸Edina, Minnesota, United States
SkinCare Physicians
🇺🇸Chestnut Hill, Massachusetts, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
Laser and Skin Surgery Center of Indiana
🇺🇸Carmel, Indiana, United States
Image Dermatology
🇺🇸Montclair, New Jersey, United States
Rancho Mirage Dermatology
🇺🇸Rancho Mirage, California, United States
Modern Research Associates, PLLC
🇺🇸Dallas, Texas, United States
Premier Clinical Research
🇺🇸Spokane, Washington, United States
DeNova Research
🇺🇸Chicago, Illinois, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
The Miami Institute
🇺🇸Miami, Florida, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research
🇺🇸Houston, Texas, United States
Ablon Skin Institute And Research Center
🇺🇸Manhattan Beach, California, United States
Dermatology Specialists, Inc.
🇺🇸Oceanside, California, United States
Diagnamics, Inc.
🇺🇸Encinitas, California, United States
Faces Plus
🇺🇸San Diego, California, United States
Syrentis Clinical Research
🇺🇸Santa Ana, California, United States
Baumann Cosmetic and Research Institute
🇺🇸Miami, Florida, United States
Miami Research Associates
🇺🇸South Miami, Florida, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Sadick Research Group
🇺🇸New York, New York, United States
Paddington Testing Co., Inc.
🇺🇸Philadelphia, Pennsylvania, United States
Chaddsford Dermatology
🇺🇸Chadds Ford, Pennsylvania, United States
Austin Institute Clinical Research
🇺🇸Pflugerville, Texas, United States
Stoll Dermatology of Beverly Hills
🇺🇸Beverly Hills, California, United States
Mercy Health Research
🇺🇸Washington, Missouri, United States
Total Skin and Beauty Dermatology Center
🇺🇸Birmingham, Alabama, United States
Colorado Medical Research Center
🇺🇸Denver, Colorado, United States
The Savin Center, PC
🇺🇸New Haven, Connecticut, United States
Clinical Research of West Florida, Inc.
🇺🇸Tampa, Florida, United States
Oregon Medical Research Center
🇺🇸Portland, Oregon, United States
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
DermResearch Inc.
🇺🇸Austin, Texas, United States