An Open-Label Study to Evaluate Retreatment With LIPO-202

August 11, 2015 updated by: Neothetics, Inc
Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

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
    • Colorado
      • Englewood, Colorado, United States, 80113
        • AboutSkin dermatology
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Dermatology Research Institute, LLC
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Gwinnett Clinical Research Center, Inc
    • Louisiana
      • New Orleans, Louisiana, United States, 70124
        • Lupo Center for Aesthetic and General Dermatology
    • New York
      • New York, New York, United States, 10065
        • Bass Plastic Surgery PLLC
      • Stony Brook, New York, United States, 11790
        • DermResearch Center of New York
    • Texas
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center of San Antonio
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Provided consent
  • Healthy male or non-pregnant female subjects
  • BMI < 30 kg/m2
  • Stable diet and exercise routine
  • Central abdominal bulging that is 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.
  • Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
  • Known hypersensitivity to study drugs
  • Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIPO-202
Drug: LIPO-202

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: vital signs, physical exams, laboratory tests
Time Frame: 12 months
12 months

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

March 1, 2015

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

March 19, 2015

First Submitted That Met QC Criteria

March 19, 2015

First Posted (Estimate)

March 25, 2015

Study Record Updates

Last Update Posted (Estimate)

August 13, 2015

Last Update Submitted That Met QC Criteria

August 11, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LIPO-202-CL-22

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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