Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat

NCT02397499 — Phase 3, Completed, 800 participants, Neothetics, Inc

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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

RegistryNCT02397499, acronym AbCONTOUR1
StatusCompleted
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment800 (Estimated)
SponsorNeothetics, Inc (Industry)
ConditionsCentral Abdominal Bulging
InterventionsLIPO-202, Placebo (Drug)
Datesstart 2015-04-01, primary completion 2015-12-01, first posted 2015-03-25, last updated 2016-01-08
Locations31 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

-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.

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+Arms and interventions

ArmTypeInterventionsDescription
LIPO-202ExperimentalDrug: LIPO-202Experimental arm
PlaceboPlacebo comparatorDrug: PlaceboPlacebo comparator
  • LIPO-202 (Drug), also known as Salmeterol
  • Placebo (Drug), also known as Placebo for LIPO-202

+Outcome measures

Primary outcomes

  • Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests. [8 weeks]: Physical examination, adverse events, vital signs, and laboratory tests.
  • 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

  • Change in waist circumference [8 weeks post the start of treatment]

+Eligibility

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

+Locations (31)

FacilityCityCountryStatus
WG Clinical ResearchTucson, ArizonaUnited States
Burke Pharmaceutical ResearchHot Springs, ArkansasUnited States
Clinical Testing Center of Beverly HillsBeverly Hills, CaliforniaUnited States
Center for Dermatology Cosmetic and Laser SurgeryFremont, CaliforniaUnited States
Dermatology/Cosmetic Laser Associates of La Jolla, IncSan Diego, CaliforniaUnited States
University Clinical Trials, Inc.San Diego, CaliforniaUnited States
Clinical Science InstituteSanta Monica, CaliforniaUnited States
The Center for Clinical & Cosmetic ResearchAventura, FloridaUnited States
Skin Care Research, Inc.Boca Raton, FloridaUnited States
Clinical Research of West Florida, Inc.Clearwater, FloridaUnited States
Clinical Research of South FloridaCoral Gables, FloridaUnited States
International Dermatology ResearchMiami, FloridaUnited States
Altman Dermatology AssociatesArlington Heights, IllinoisUnited States
Glazer DermatologyBuffalo Grove, IllinoisUnited States
Dermatology Specialists ResearchLouisville, KentuckyUnited States
Grekin Skin InstituteWarren, MichiganUnited States
Minnesota Clinical Study CenterFridley, MinnesotaUnited States
Skin Specialists, PCOmaha, NebraskaUnited States
Skin Laser & Surgery Specialist of NY/NJHackensack, New JerseyUnited States
Juva Skin & Laser CenterNew York, New YorkUnited States
Skin Specialty DermatologyNew York, New YorkUnited States
Marina I Peredo, M.D, P.C.Smithtown, New YorkUnited States
Aesthetic SolutionsChapel Hill, North CarolinaUnited States
Dermatology, Laser and Vein Specialists of the CarolinasCharlotte, North CarolinaUnited States
Westlake Dermatology Clinical Research CenterAustin, TexasUnited States
J & S Studies, Inc.College Station, TexasUnited States
Menter Dermatology Research CenterDallas, TexasUnited States
Suzanne Bruce and Associates, P.A., The Center for Skin ResearchKaty, TexasUnited States
Research Across AmericaPlano, TexasUnited States
Dermatology Research Center, Inc.Salt Lake City, UtahUnited States
Virginia Clinical Research, Inc.Norfolk, VirginiaUnited States

+Investigators