Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
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
1 other identifier
interventional
793
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2015
Shorter than P25 for phase_3
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2015
CompletedFirst Posted
Study publicly available on registry
March 25, 2015
CompletedStudy Start
First participant enrolled
April 9, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2015
CompletedResults Posted
Study results publicly available
January 7, 2019
CompletedJanuary 7, 2019
October 1, 2018
7 months
March 19, 2015
October 29, 2018
January 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
8 weeks post the start of treatment
Secondary Outcomes (1)
Percent Change in Waist Circumference
8 weeks post the start of treatment
Study Arms (2)
LIPO-202
EXPERIMENTALExperimental arm
Placebo
PLACEBO COMPARATORPlacebo comparator
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Evofem Inc.lead
- Neothetics, Inccollaborator
Study Sites (35)
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205, United States
Stoll Dermatology of Beverly Hills
Beverly Hills, California, 90212, United States
Diagnamics, Inc.
Encinitas, California, 92024, United States
Ablon Skin Institute And Research Center
Manhattan Beach, California, 90266, United States
Dermatology Specialists, Inc.
Oceanside, California, 92056, United States
Rancho Mirage Dermatology
Rancho Mirage, California, 92270, United States
Faces Plus
San Diego, California, 92121, United States
Therapeutics Clinical Research
San Diego, California, 92126, United States
Syrentis Clinical Research
Santa Ana, California, 92705, United States
Colorado Medical Research Center
Denver, Colorado, 80210, United States
The Savin Center, PC
New Haven, Connecticut, 06511, United States
Altus Research
Lake Worth, Florida, 33461, United States
The Miami Institute
Miami, Florida, 33131, United States
Baumann Cosmetic and Research Institute
Miami, Florida, 33137, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603, United States
DeNova Research
Chicago, Illinois, 60611, United States
Laser and Skin Surgery Center of Indiana
Carmel, Indiana, 46032, United States
South Bend Clinic
South Bend, Indiana, 46617, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467, United States
Zel Skin & Laser Specialist, LLC
Edina, Minnesota, 55424, United States
Mercy Health Research
Washington, Missouri, 63090, United States
Image Dermatology
Montclair, New Jersey, 07042, United States
Sadick Research Group
New York, New York, 10075, United States
Wake Research Associates
Raleigh, North Carolina, 27612, United States
Oregon Medical Research Center
Portland, Oregon, 97223, United States
Chaddsford Dermatology
Chadds Ford, Pennsylvania, 19317, United States
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, 19103, United States
Society Hill Dermatology
Philadelphia, Pennsylvania, 19107, United States
Tennessee Clinical Research Center
Nashville, Tennessee, 37215, United States
DermResearch Inc.
Austin, Texas, 78759, United States
Modern Research Associates, PLLC
Dallas, Texas, 75231, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Houston, Texas, 77056, United States
Austin Institute Clinical Research
Pflugerville, Texas, 78660, United States
Premier Clinical Research
Spokane, Washington, 99202, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neothetics Clinical
- Organization
- Neothetics, Inc.
Study Officials
- STUDY DIRECTOR
Maria Feldman
Neothetics, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2015
First Posted
March 25, 2015
Study Start
April 9, 2015
Primary Completion
October 29, 2015
Study Completion
October 29, 2015
Last Updated
January 7, 2019
Results First Posted
January 7, 2019
Record last verified: 2018-10