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NCT02398188 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
A Phase 3 study of Central Abdominal Bulging, sponsored by Evofem.
- Completed
- Registry status
- Phase 3
- Development phase
- 793
- Enrollment target
- 20
- Study locations
NCT02398188: Completed Phase 3 study of Central Abdominal Bulging, sponsored by Evofem.
NCT02398188 is a Phase 3 study of Central Abdominal Bulging that has completed, run by Evofem. The registered enrollment target is 793 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02398188, a Phase 3 study of Central Abdominal Bulging, has completed, sponsored by Evofem.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 793 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 abdomina
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LIPO-202
Study Locations (20)
California
- Stoll Dermatology of Beverly Hills - Beverly Hills
- Diagnamics, Inc. - Encinitas
- Ablon Skin Institute And Research Center - Manhattan Beach
- Dermatology Specialists, Inc. - Oceanside
- Rancho Mirage Dermatology - Rancho Mirage
- Faces Plus - San Diego
- Therapeutics Clinical Research - San Diego
- Syrentis Clinical Research - Santa Ana
Florida
- Altus Research - Lake Worth
- The Miami Institute - Miami
- Baumann Cosmetic and Research Institute - Miami
- Miami Research Associates - South Miami
- Clinical Research of West Florida, Inc. - Tampa
Indiana
- Laser and Skin Surgery Center of Indiana - Carmel
- South Bend Clinic - South Bend
Alabama
- Total Skin and Beauty Dermatology Center - Birmingham
Colorado
- Colorado Medical Research Center - Denver
Connecticut
- The Savin Center, PC - New Haven
Illinois
- DeNova Research - Chicago
Massachusetts
- SkinCare Physicians - Chestnut Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 793 participants |
| Start Date | 2015-04-09 |
| Est. Completion | 2015-10-29 |
| Phase | Phase 3 |
What the finished NCT02398188 record still lists
NCT02398188 is an interventional study that assigns participants to a tested intervention. The registered 793 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 1 condition, with Central Abdominal Bulging appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02398188 names 20 study sites across 8 states, led by California, Florida, Indiana.
Frequently Asked Questions
What is clinical trial NCT02398188 about?
NCT02398188 is a clinical study titled "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.
What is the current status of trial NCT02398188?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 793 participants. The study started on 2015-04-09. Estimated completion is 2015-10-29.
What conditions does trial NCT02398188 study?
This clinical trial studies the following conditions: Central Abdominal Bulging.
What interventions are being tested in trial NCT02398188?
The interventions under investigation include: Placebo (DRUG), LIPO-202 (DRUG).
Who is sponsoring clinical trial NCT02398188?
This trial is sponsored by Evofem, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02398188 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02398188's enrollment target sits among peer trials
793 429th of 2000 higher than 1,572 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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