Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR1)

January 6, 2016 updated by: Neothetics, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85704
        • WG Clinical Research
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
    • California
      • Beverly Hills, California, United States, 90210
        • Clinical Testing Center of Beverly Hills
      • Fremont, California, United States, 94538
        • Center For Dermatology Cosmetic and Laser Surgery
      • San Diego, California, United States, 92123
        • University Clinical Trials, Inc.
      • San Diego, California, United States, 92121
        • Dermatology/Cosmetic Laser Associates of La Jolla, Inc
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • Florida
      • Aventura, Florida, United States, 33180
        • The Center for Clinical & Cosmetic Research
      • Boca Raton, Florida, United States, 33486
        • Skin Care Research, Inc.
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Coral Gables, Florida, United States, 33134
        • Clinical Research of South Florida
      • Miami, Florida, United States, 33144
        • International Dermatology Research
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Altman Dermatology Associates
      • Buffalo Grove, Illinois, United States, 60089
        • Glazer Dermatology
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Dermatology Specialists Research
    • Michigan
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Skin Laser & Surgery Specialist of NY/NJ
    • New York
      • New York, New York, United States, 10155
        • Skin Specialty Dermatology
      • New York, New York, United States, 10022
        • JUVA Skin & Laser Center
      • Smithtown, New York, United States, 11787
        • Marina I Peredo, M.D, P.C.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27517
        • Aesthetic Solutions
      • Charlotte, North Carolina, United States, 28207
        • Dermatology, Laser and Vein Specialists of the Carolinas
    • Texas
      • Austin, Texas, United States, 78746
        • Westlake Dermatology Clinical Research Center
      • College Station, Texas, United States, 77845
        • J & S Studies, Inc.
      • Dallas, Texas, United States, 75246
        • Menter Dermatology Research Center
      • Katy, Texas, United States, 77494
        • Suzanne Bruce and Associates, P.A., The Center for Skin Research
      • Plano, Texas, United States, 75093
        • Research Across America
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Dermatology Research Center, Inc.
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo
Other Names:
  • Placebo for LIPO-202
Experimental: LIPO-202
Experimental arm
Drug: LIPO-202
Other Names:
  • Salmeterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests.
Time Frame: 8 weeks
Physical examination, adverse events, vital signs, and laboratory tests.
8 weeks
Change in the clinician reported photonumeric score
Time Frame: 8 weeks post the start of treatment
8 weeks post the start of treatment
Change in the patient reported global abdominal perception score
Time Frame: 8 weeks post the start of treatment
8 weeks post the start of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in waist circumference
Time Frame: 8 weeks post the start of treatment
8 weeks post the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neothetics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 24, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 6, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPO-202-CL-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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