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| Name | Class |
|---|---|
| Neothetics, Inc | INDUSTRY |
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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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LIPO-202 | Drug |
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| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent 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 |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center | Birmingham | Alabama | 35205 | United States | ||
| Stoll Dermatology of Beverly Hills |
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| ID | Title | Description |
|---|---|---|
| FG000 | LIPO-202 | Experimental arm LIPO-202 |
| FG001 | Placebo | Placebo comparator Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
|
| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LIPO-202 | Experimental arm LIPO-202 |
| BG001 | Placebo | Placebo comparator Placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT Population | Posted | Count of Participants | Participants | Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment) |
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| Primary | 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. | Posted | Mean | Standard Deviation | percent change | 8 weeks post the start of treatment |
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| Secondary | Percent Change in Waist Circumference | Posted | Mean | Standard Deviation | percent change | 8 weeks post the start of treatment |
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The collection of adverse events from the first dose of study drug until the End-of-Study Visit (one week post last treatment) or at the Early Termination Visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LIPO-202 | Experimental arm LIPO-202 | 0 | 398 | 1 | 398 | 138 | 398 |
| EG001 | Placebo | Placebo comparator Placebo | 0 | 395 | 1 | 395 | 150 | 395 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Bruising | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection Site Haemorrhage | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection Site Pain | General disorders | MedDRA 18.0 | Systematic Assessment |
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| Injection Site Erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neothetics Clinical | Neothetics, Inc. | 858-550-1900 |
| 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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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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