Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat
AbCONTOUR1
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
800
1 country
31
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
31 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 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedJanuary 8, 2016
January 1, 2016
8 months
March 19, 2015
January 6, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests.
Physical examination, adverse events, vital signs, and laboratory tests.
8 weeks
Change in the clinician reported photonumeric score
8 weeks post the start of treatment
Change in the patient reported global abdominal perception score
8 weeks post the start of treatment
Secondary Outcomes (1)
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
- Neothetics, Inclead
Study Sites (31)
WG Clinical Research
Tucson, Arizona, 85704, United States
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913, United States
Clinical Testing Center of Beverly Hills
Beverly Hills, California, 90210, United States
Center for Dermatology Cosmetic and Laser Surgery
Fremont, California, 94538, United States
Dermatology/Cosmetic Laser Associates of La Jolla, Inc
San Diego, California, 92121, United States
University Clinical Trials, Inc.
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
The Center for Clinical & Cosmetic Research
Aventura, Florida, 33180, United States
Skin Care Research, Inc.
Boca Raton, Florida, 33486, United States
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765, United States
Clinical Research of South Florida
Coral Gables, Florida, 33134, United States
International Dermatology Research
Miami, Florida, 33144, United States
Altman Dermatology Associates
Arlington Heights, Illinois, 60005, United States
Glazer Dermatology
Buffalo Grove, Illinois, 60089, United States
Dermatology Specialists Research
Louisville, Kentucky, 40202, United States
Grekin Skin Institute
Warren, Michigan, 48088, United States
Minnesota Clinical Study Center
Fridley, Minnesota, 55432, United States
Skin Specialists, PC
Omaha, Nebraska, 68144, United States
Skin Laser & Surgery Specialist of NY/NJ
Hackensack, New Jersey, 07601, United States
Juva Skin & Laser Center
New York, New York, 10022, United States
Skin Specialty Dermatology
New York, New York, 10155, United States
Marina I Peredo, M.D, P.C.
Smithtown, New York, 11787, United States
Aesthetic Solutions
Chapel Hill, North Carolina, 27517, United States
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207, United States
Westlake Dermatology Clinical Research Center
Austin, Texas, 78746, United States
J & S Studies, Inc.
College Station, Texas, 77845, United States
Menter Dermatology Research Center
Dallas, Texas, 75246, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Katy, Texas, 77494, United States
Research Across America
Plano, Texas, 75093, United States
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117, United States
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Maria Feldman
Neothetics, Inc
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 1, 2015
Primary Completion
December 1, 2015
Last Updated
January 8, 2016
Record last verified: 2016-01