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Completed

NCT Number: NCT02398188

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

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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Key information

Conditions

Central Abdominal Bulging

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Total Skin and Beauty Dermatology Center, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIPO-202

Drug

Other names: Salmeterol

Placebo

Drug

Other names: Placebo for LIPO-202

Primary outcomes

  1. Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response

    Time frame: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)

    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.

  2. Percent Change in the Patient Reported Global Abdominal Perception Score

    Time frame: 8 weeks post the start of treatment

    1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.

Secondary outcomes

  1. Percent Change in Waist Circumference

    Time frame: 8 weeks post the start of treatment

Sponsors and collaborators

Lead sponsor

Evofem Inc.

Industry

Collaborators

  • Neothetics, Inc

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 25, 2015
Registry last updated
Jan 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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