Clinical trial NCT02398188: Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Abdominal Bulging
Lead sponsor: Evofem Inc.
Sponsor class: INDUSTRY
Collaborators: name: Neothetics, Inc
First posted: 2015-03-25
Enrollment: 793
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Who Achieved a Composite P-GAPS1/CPnS2 Response
timeFrame: Baseline and End of Study (1 week post last treatment, 9 weeks after first treatment)
measure: Percent Change in the Patient Reported Global Abdominal Perception Score
timeFrame: 8 weeks post the start of treatment
Secondary outcomes:
measure: Percent Change in Waist Circumference
timeFrame: 8 weeks post the start of treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Total Skin and Beauty Dermatology Center
state: Alabama
city: Beverly Hills
country: United States
facility: Stoll Dermatology of Beverly Hills
state: California
city: Encinitas
country: United States
facility: Diagnamics, Inc.
state: California
city: Manhattan Beach
country: United States
facility: Ablon Skin Institute And Research Center
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: Rancho Mirage
country: United States
facility: Rancho Mirage Dermatology
state: California
city: San Diego
country: United States
facility: Faces Plus
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center
state: Colorado
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: Lake Worth
country: United States
facility: Altus Research
state: Florida
city: Miami
country: United States
facility: The Miami Institute
state: Florida
city: Miami
country: United States
facility: Baumann Cosmetic and Research Institute
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Florida, Inc.
state: Florida
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
city: Carmel
country: United States
facility: Laser and Skin Surgery Center of Indiana
state: Indiana
city: South Bend
country: United States
facility: South Bend Clinic
state: Indiana
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
city: Edina
country: United States
facility: Zel Skin & Laser Specialist, LLC
state: Minnesota
city: Washington
country: United States
facility: Mercy Health Research
state: Missouri
city: Montclair
country: United States
facility: Image Dermatology
state: New Jersey
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Chadds Ford
country: United States
facility: Chaddsford Dermatology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Co., Inc.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Society Hill Dermatology
state: Pennsylvania
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: Austin
country: United States
facility: DermResearch Inc.
state: Texas
city: Dallas
country: United States
facility: Modern Research Associates, PLLC
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A., The Center for Skin Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute Clinical Research
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Neothetics, Inc
name: Maria Feldman
role: STUDY_DIRECTOR
References: