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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LIPO-202 | Experimental | Experimental arm |
|
| Placebo | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIPO-202 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in waist circumference | 8 weeks post the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Feldman | Neothetics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| WG Clinical Research | Tucson | Arizona | 85704 | United States | ||
| Burke Pharmaceutical Research |
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| Drug |
|
|
| 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 |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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