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

Phase 3

Completed

• Conditions: Central Abdominal Bulging
• Interventions: Drug: LIPO-202; Drug: Placebo

• Registration Number: NCT02398188
• Lead Sponsor: Evofem Inc.

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Study Start: 2015-04-09
• Primary Completion: 2015-10-29
• Study Completion: 2015-10-29
• Status Verified: 2018-10
• Results First Submitted: 2018-10-29
• Results First Submitted QC: 2019-01-04
• Last Update Submitted: 2019-01-04
• Results First Posted: 2019-01-07
• Last Update Posted: 2019-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 793

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIPO-202	LIPO-202	Experimental arm
Placebo	Placebo	Placebo comparator

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response	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.
Percent Change in the Patient Reported Global Abdominal Perception Score	8 weeks post the start of treatment	1 equals much improved, 7 equals much worse. The higher the scores the worse the outcome.

Secondary Outcome Measures

Name	Time	Method
Percent Change in Waist Circumference	8 weeks post the start of treatment

Trial Locations

Locations (35)

Total Skin and Beauty Dermatology Center; 🇺🇸 Birmingham, Alabama, United States

Stoll Dermatology of Beverly Hills; 🇺🇸 Beverly Hills, California, United States

Diagnamics, Inc.; 🇺🇸 Encinitas, California, United States

Ablon Skin Institute And Research Center; 🇺🇸 Manhattan Beach, California, United States

Dermatology Specialists, Inc.; 🇺🇸 Oceanside, California, United States

Rancho Mirage Dermatology; 🇺🇸 Rancho Mirage, California, United States

Faces Plus; 🇺🇸 San Diego, California, United States

Therapeutics Clinical Research; 🇺🇸 San Diego, California, United States

Syrentis Clinical Research; 🇺🇸 Santa Ana, California, United States

Colorado Medical Research Center; 🇺🇸 Denver, Colorado, United States

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