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
| Registry | NCT02397499, acronym AbCONTOUR1 |
|---|---|
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 800 (Estimated) |
| Sponsor | Neothetics, Inc (Industry) |
| Conditions | Central Abdominal Bulging |
| Interventions | LIPO-202, Placebo (Drug) |
| Dates | start 2015-04-01, primary completion 2015-12-01, first posted 2015-03-25, last updated 2016-01-08 |
| Locations | 31 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Central Abdominal Bulging All trials of LIPO-202 All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| LIPO-202 | Experimental | Drug: LIPO-202 | Experimental arm |
| Placebo | Placebo comparator | Drug: Placebo | Placebo comparator |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| WG Clinical Research | Tucson, Arizona | United States | |
| Burke Pharmaceutical Research | Hot Springs, Arkansas | United States | |
| Clinical Testing Center of Beverly Hills | Beverly Hills, California | United States | |
| Center for Dermatology Cosmetic and Laser Surgery | Fremont, California | United States | |
| Dermatology/Cosmetic Laser Associates of La Jolla, Inc | San Diego, California | United States | |
| University Clinical Trials, Inc. | San Diego, California | United States | |
| Clinical Science Institute | Santa Monica, California | United States | |
| The Center for Clinical & Cosmetic Research | Aventura, Florida | United States | |
| Skin Care Research, Inc. | Boca Raton, Florida | United States | |
| Clinical Research of West Florida, Inc. | Clearwater, Florida | United States | |
| Clinical Research of South Florida | Coral Gables, Florida | United States | |
| International Dermatology Research | Miami, Florida | United States | |
| Altman Dermatology Associates | Arlington Heights, Illinois | United States | |
| Glazer Dermatology | Buffalo Grove, Illinois | United States | |
| Dermatology Specialists Research | Louisville, Kentucky | United States | |
| Grekin Skin Institute | Warren, Michigan | United States | |
| Minnesota Clinical Study Center | Fridley, Minnesota | United States | |
| Skin Specialists, PC | Omaha, Nebraska | United States | |
| Skin Laser & Surgery Specialist of NY/NJ | Hackensack, New Jersey | United States | |
| Juva Skin & Laser Center | New York, New York | United States | |
| Skin Specialty Dermatology | New York, New York | United States | |
| Marina I Peredo, M.D, P.C. | Smithtown, New York | United States | |
| Aesthetic Solutions | Chapel Hill, North Carolina | United States | |
| Dermatology, Laser and Vein Specialists of the Carolinas | Charlotte, North Carolina | United States | |
| Westlake Dermatology Clinical Research Center | Austin, Texas | United States | |
| J & S Studies, Inc. | College Station, Texas | United States | |
| Menter Dermatology Research Center | Dallas, Texas | United States | |
| Suzanne Bruce and Associates, P.A., The Center for Skin Research | Katy, Texas | United States | |
| Research Across America | Plano, Texas | United States | |
| Dermatology Research Center, Inc. | Salt Lake City, Utah | United States | |
| Virginia Clinical Research, Inc. | Norfolk, Virginia | United States |