Central Abdominal BulgingPhase 3NCT02398188
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat (AbCONTOUR2)
A Phase 3 study testing LIPO-202 in people with Central Abdominal Bulging, run by Evofem Inc. at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Central Abdominal Bulging
- What is being tested?
- LIPO-202
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 793 participants
- Where
- 35 sitesUnited States
- Study dates
- 9 Apr 2015to 29 Oct 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
DermResearch Inc.
Austin, Texas, 78759
Stoll Dermatology of Beverly Hills
Beverly Hills, California, 90212
Total Skin and Beauty Dermatology Center
Birmingham, Alabama, 35205
Laser and Skin Surgery Center of Indiana
Carmel, Indiana, 46032
Chaddsford Dermatology
Chadds Ford, Pennsylvania, 19317
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
DeNova Research
Chicago, Illinois, 60611
Modern Research Associates, PLLC
Dallas, Texas, 75231
Colorado Medical Research Center
Denver, Colorado, 80210
Zel Skin & Laser Specialist, LLC
Edina, Minnesota, 55424
Diagnamics, Inc.
Encinitas, California, 92024
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Houston, Texas, 77056
Altus Research
Lake Worth, Florida, 33461
Ablon Skin Institute And Research Center
Manhattan Beach, California, 90266
The Miami Institute
Miami, Florida, 33131
Baumann Cosmetic and Research Institute
Miami, Florida, 33137
Image Dermatology
Montclair, New Jersey, 07042
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
The Savin Center, PC
New Haven, Connecticut, 06511
Sadick Research Group
New York, New York, 10075
Dermatology Specialists, Inc.
Oceanside, California, 92056
Austin Institute Clinical Research
Pflugerville, Texas, 78660
Paddington Testing Co., Inc.
Philadelphia, Pennsylvania, 19103
Society Hill Dermatology
Philadelphia, Pennsylvania, 19107
Oregon Medical Research Center
Portland, Oregon, 97223
Wake Research Associates
Raleigh, North Carolina, 27612
Rancho Mirage Dermatology
Rancho Mirage, California, 92270
Faces Plus
San Diego, California, 92121
Therapeutics Clinical Research
San Diego, California, 92126
Syrentis Clinical Research
Santa Ana, California, 92705
South Bend Clinic
South Bend, Indiana, 46617
Miami Research Associates
South Miami, Florida, 33143
Premier Clinical Research
Spokane, Washington, 99202
Clinical Research of West Florida, Inc.
Tampa, Florida, 33603
Mercy Health Research
Washington, Missouri, 63090
About this study
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
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.
- Conditions
- Central Abdominal Bulging
- Being tested
- LIPO-202, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIPO-202Drug
Also called Salmeterol
PlaceboDrug
Also called Placebo for LIPO-202
| Study group | Role | What they receive |
|---|---|---|
| LIPO-202 | Experimental | Experimental arm Receives: Drug: LIPO-202 |
| Placebo | Placebo comparator | Placebo comparator Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks post the start of treatment
Secondary outcomes (1)
Percent Change in Waist Circumference
Measured: 8 weeks post the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study start9 Apr 2015
- Primary completion29 Oct 2015
- Study completion29 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Abdominal BulgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evofem Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Neothetics, Inc
- Responsible party
- Sponsor
- Investigators
- Maria Feldman, Study director, Neothetics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398188
- Sponsor's protocol ID
- LIPO-202-CL-19
- Status last verified
- Oct 2018
- First submitted
- 19 Mar 2015
- Last updated
- 7 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02398188
- Acronym / sponsor ID
- LIPO-202-CL-19
- Conditions
- Central Abdominal Bulging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Evofem Inc.Industry (pharma, biotech, devices)
- Collaborators
- Neothetics, Inc
- Study start
- 9 Apr 2015 (actual)
- Primary completion
- 29 Oct 2015 (actual)
- Study completion
- 29 Oct 2015 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Posted 7 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LIPO-202 | Experimental | Drug: LIPO-202Experimental arm |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo comparator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LIPO-202Also: Salmeterol | Drug | LIPO-202 |
| PlaceboAlso: Placebo for LIPO-202 | Drug | Placebo |
Primary outcome
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.
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.
1 secondary outcome
Percent Change in Waist Circumference
Time frame: 8 weeks post the start of treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Feldman study director
Neothetics, Inc
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LIPO-202 in people with Central Abdominal Bulging, run by Evofem Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.