Central Abdominal BulgingPhase 3AbCONTOUR1NCT02397499
Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat
A Phase 3 study testing LIPO-202 in people with Central Abdominal Bulging, run by Neothetics, Inc at 31 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 older
- 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
- 800 participants
- Where
- 31 sitesUnited States
- Study dates
- Apr 2015to Dec 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- 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
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Altman Dermatology Associates
Arlington Heights, Illinois, 60005
Westlake Dermatology Clinical Research Center
Austin, Texas, 78746
The Center for Clinical & Cosmetic Research
Aventura, Florida, 33180
Clinical Testing Center of Beverly Hills
Beverly Hills, California, 90210
Skin Care Research, Inc.
Boca Raton, Florida, 33486
Glazer Dermatology
Buffalo Grove, Illinois, 60089
Aesthetic Solutions
Chapel Hill, North Carolina, 27517
Dermatology, Laser and Vein Specialists of the Carolinas
Charlotte, North Carolina, 28207
Clinical Research of West Florida, Inc.
Clearwater, Florida, 33765
J & S Studies, Inc.
College Station, Texas, 77845
Clinical Research of South Florida
Coral Gables, Florida, 33134
Menter Dermatology Research Center
Dallas, Texas, 75246
Center for Dermatology Cosmetic and Laser Surgery
Fremont, California, 94538
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Skin Laser & Surgery Specialist of NY/NJ
Hackensack, New Jersey, 07601
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913
Suzanne Bruce and Associates, P.A., The Center for Skin Research
Katy, Texas, 77494
Dermatology Specialists Research
Louisville, Kentucky, 40202
International Dermatology Research
Miami, Florida, 33144
Juva Skin & Laser Center
New York, New York, 10022
Skin Specialty Dermatology
New York, New York, 10155
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
Skin Specialists, PC
Omaha, Nebraska, 68144
Research Across America
Plano, Texas, 75093
Dermatology Research Center, Inc.
Salt Lake City, Utah, 84117
Dermatology/Cosmetic Laser Associates of La Jolla, Inc
San Diego, California, 92121
University Clinical Trials, Inc.
San Diego, California, 92123
Clinical Science Institute
Santa Monica, California, 90404
Marina I Peredo, M.D, P.C.
Smithtown, New York, 11787
WG Clinical Research
Tucson, Arizona, 85704
Grekin Skin Institute
Warren, Michigan, 48088
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.
Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests.
Physical examination, adverse events, vital signs, and laboratory tests.
Measured: 8 weeks
Change in the clinician reported photonumeric score
Measured: 8 weeks post the start of treatment
Change in the patient reported global abdominal perception score
Measured: 8 weeks post the start of treatment
Secondary outcomes (1)
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 startApr 2015
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neothetics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Feldman, Study director, Neothetics, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02397499
- Sponsor's protocol ID
- LIPO-202-CL-18
- Acronym
- AbCONTOUR1
- Status last verified
- Jan 2016
- First submitted
- 19 Mar 2015
- Last updated
- 8 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2016. 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
- NCT02397499
- Acronym / sponsor ID
- AbCONTOUR1 / LIPO-202-CL-18
- Conditions
- Central Abdominal Bulging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Neothetics, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Dec 2015 (actual)
- First posted
- 25 Mar 2015 (estimated)
- Results
- Not posted in the source record
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
- Not 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
Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests.
Time frame: 8 weeks
Physical examination, adverse events, vital signs, and laboratory tests.
Change in the clinician reported photonumeric score
Time frame: 8 weeks post the start of treatment
Change in the patient reported global abdominal perception score
Time frame: 8 weeks post the start of treatment
1 secondary outcome
Change in waist circumference
Time frame: 8 weeks post the start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2016.
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
31 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 Neothetics, Inc at 31 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 8 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Safety as measured by Physical examination, adverse events, vital signs, and laboratory tests. (time frame: 8 weeks). The study lists 3 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 8 Jan 2016.