Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)

NCT ID: NCT02398188

Last Updated: 2019-01-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

793 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-09

Study Completion Date

2015-10-29

Brief Summary

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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.

Detailed Description

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Conditions

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Central Abdominal Bulging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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LIPO-202

Experimental arm

Group Type EXPERIMENTAL

LIPO-202

Intervention Type DRUG

Placebo

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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LIPO-202

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Salmeterol Placebo for LIPO-202

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Neothetics, Inc

INDUSTRY

Sponsor Role collaborator

Evofem Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Feldman

Role: STUDY_DIRECTOR

Neothetics, Inc

Locations

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Total Skin and Beauty Dermatology Center

Birmingham, Alabama, United States

Site Status

Stoll Dermatology of Beverly Hills

Beverly Hills, California, United States

Site Status

Diagnamics, Inc.

Encinitas, California, United States

Site Status

Ablon Skin Institute And Research Center

Manhattan Beach, California, United States

Site Status

Dermatology Specialists, Inc.

Oceanside, California, United States

Site Status

Rancho Mirage Dermatology

Rancho Mirage, California, United States

Site Status

Faces Plus

San Diego, California, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

Syrentis Clinical Research

Santa Ana, California, United States

Site Status

Colorado Medical Research Center

Denver, Colorado, United States

Site Status

The Savin Center, PC

New Haven, Connecticut, United States

Site Status

Altus Research

Lake Worth, Florida, United States

Site Status

The Miami Institute

Miami, Florida, United States

Site Status

Baumann Cosmetic and Research Institute

Miami, Florida, United States

Site Status

Miami Research Associates

South Miami, Florida, United States

Site Status

Clinical Research of West Florida, Inc.

Tampa, Florida, United States

Site Status

DeNova Research

Chicago, Illinois, United States

Site Status

Laser and Skin Surgery Center of Indiana

Carmel, Indiana, United States

Site Status

South Bend Clinic

South Bend, Indiana, United States

Site Status

SkinCare Physicians

Chestnut Hill, Massachusetts, United States

Site Status

Zel Skin & Laser Specialist, LLC

Edina, Minnesota, United States

Site Status

Mercy Health Research

Washington, Missouri, United States

Site Status

Image Dermatology

Montclair, New Jersey, United States

Site Status

Sadick Research Group

New York, New York, United States

Site Status

Wake Research Associates

Raleigh, North Carolina, United States

Site Status

Oregon Medical Research Center

Portland, Oregon, United States

Site Status

Chaddsford Dermatology

Chadds Ford, Pennsylvania, United States

Site Status

Paddington Testing Co., Inc.

Philadelphia, Pennsylvania, United States

Site Status

Society Hill Dermatology

Philadelphia, Pennsylvania, United States

Site Status

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Site Status

DermResearch Inc.

Austin, Texas, United States

Site Status

Modern Research Associates, PLLC

Dallas, Texas, United States

Site Status

Suzanne Bruce and Associates, P.A., The Center for Skin Research

Houston, Texas, United States

Site Status

Austin Institute Clinical Research

Pflugerville, Texas, United States

Site Status

Premier Clinical Research

Spokane, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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LIPO-202-CL-19

Identifier Type: -

Identifier Source: org_study_id

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