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

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: Central Abdominal Bulging
• Intervention / Treatment: Drug: Placebo; Drug: LIPO-202

• Study Type: Interventional
• Enrollment (Actual): 793
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Total Skin and Beauty Dermatology Center
  • California
    • Beverly Hills, California, United States, 90212
      • Stoll Dermatology of Beverly Hills
    • Encinitas, California, United States, 92024
      • Diagnamics, Inc.
    • Manhattan Beach, California, United States, 90266
      • Ablon Skin Institute and Research Center
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc.
    • Rancho Mirage, California, United States, 92270
      • Rancho Mirage Dermatology
    • San Diego, California, United States, 92121
      • Faces Plus
    • San Diego, California, United States, 92126
      • Therapeutics Clinical Research
    • Santa Ana, California, United States, 92705
      • Syrentis Clinical Research
  • Colorado
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • The Savin Center, PC
  • Florida
    • Lake Worth, Florida, United States, 33461
      • Altus Research
    • Miami, Florida, United States, 33137
      • Baumann Cosmetic and Research Institute
    • Miami, Florida, United States, 33131
      • The Miami Institute
    • South Miami, Florida, United States, 33143
      • Miami Research Associates
    • Tampa, Florida, United States, 33603
      • Clinical Research of West Florida, Inc.
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Laser and Skin Surgery Center of Indiana
    • South Bend, Indiana, United States, 46617
      • South Bend Clinic
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • SkinCare Physicians
  • Minnesota
    • Edina, Minnesota, United States, 55424
      • Zel Skin & Laser Specialist, LLC
  • Missouri
    • Washington, Missouri, United States, 63090
      • Mercy Health Research
  • New Jersey
    • Montclair, New Jersey, United States, 07042
      • Image Dermatology
  • New York
    • New York, New York, United States, 10075
      • Sadick Research Group
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates
  • Oregon
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Pennsylvania
    • Chadds Ford, Pennsylvania, United States, 19317
      • Chaddsford Dermatology
    • Philadelphia, Pennsylvania, United States, 19107
      • Society Hill Dermatology
    • Philadelphia, Pennsylvania, United States, 19103
      • Paddington Testing Co., Inc.
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Tennessee Clinical Research Center
  • Texas
    • Austin, Texas, United States, 78759
      • DermResearch Inc.
    • Dallas, Texas, United States, 75231
      • Modern Research Associates, PLLC
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, P.A., The Center for Skin Research
    • Pflugerville, Texas, United States, 78660
      • Austin Institute Clinical Research
  • Washington
    • Spokane, Washington, United States, 99202
      • Premier Clinical Research

Participation Criteria

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:

• 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

How is the study designed?

Design Details

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

Number of Arms

2

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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent Change in Waist Circumference	8 weeks post the start of treatment

Collaborators and Investigators

• Sponsor: Evofem Inc.
• Collaborators: Neothetics, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 9, 2015
• Primary Completion (Actual): October 29, 2015
• Study Completion (Actual): October 29, 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 (Actual): January 7, 2019
• Last Update Submitted That Met QC Criteria: January 4, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Salmeterol Xinafoate
• Other Study ID Numbers: LIPO-202-CL-19