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Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Submental Subcutaneous Fat

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ClinicalTrials.gov Identifier: NCT03005717
Recruitment Status : Completed
First Posted : December 29, 2016
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Neothetics, Inc

Brief Summary:
Study LIPO-202-CL-31 is a multi center, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of two different doses of LIPO-202 versus placebo on submental bulging due to subcutaneous fat. Approximately 150 participants of either gender who have a "Moderate Bulge" or "Large Bulge" in the submental fat (on Patient-Reported Submental Bulging Scale [PR-SBS] and Clinician-Reported Submental Bulging Scale [CR-SBS]) will be recruited for this study.

Condition or disease Intervention/treatment Phase
Submental Fat Drug: LIPO-202 Drug: Placebo for LIPO-202 Phase 2

Detailed Description:

Potential subjects will present and complete the Screening Visit. All qualifying subjects will be randomized to one of three treatment groups and treated with up to 30 subcutaneous injections of the assigned study drug into submental fat, once a week for 8 weeks. Upon completion of treatment visits, subject will return to the clinic for a follow-up visit and end of study visit, one and four weeks after the last treatment. The number and pattern of injections will be based on the area (cm x cm) of submental fat at baseline. At each visit the subjects will also undergo an examination of the treatment area, collection of vital signs and questioning about possible adverse events (AEs).

The study consists of 11 visits: a Screening Visit, eight Treatment Visits, a Follow up Visit and an End of Study Visit.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of LIPO-202 (Salmeterol Xinafoate for Injection) for the Reduction of Submental Subcutaneous Fat
Actual Study Start Date : December 22, 2016
Actual Primary Completion Date : June 2, 2017
Actual Study Completion Date : June 2, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active High
Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX
Drug: LIPO-202
Other Name: Salmeterol Xinafoate for Injection

Experimental: Active Low
Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.02 mcg SX/mL Total Weekly Dose: up to 0.3 mcg SX
Drug: LIPO-202
Other Name: Salmeterol Xinafoate for Injection

Placebo Comparator: Placebo
Placebo for LIPO 202 (Salmeterol Xinafoate for Injection)
Drug: Placebo for LIPO-202
Lyophile manufactured to mimic LIPO-202 lyophile.
Other Name: Placebo




Primary Outcome Measures :
  1. Safety as measured by number of subjects with adverse events. [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
  2. Safety as measured by the number of subjects with abnormal post baseline shifts in laboratory results. [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
  3. Change from baseline in the patient reported submental bulging scale. [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
    The self-rating scale is 5-point scale that the subject evaluates their submental fat.

  4. Change from baseline in the clinician reported submental bulging scale [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]
    The clinician scale is 5-point rating scale in which the clinician evaluates the subject's submental fat.

  5. Change in submental fat thickness measured with calipers (mm). [ Time Frame: 12 weeks (Baseline through 4 weeks post last dose) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy males or non-pregnant females;
  2. Capable of providing written, informed consent; and ,
  3. Have submental bulging that is evaluated by the Investigator as "Moderate" or "Large".

Exclusion Criteria:

  1. History of prior treatment to reduce submental bulging;
  2. History of derm fillers, chemical peels, or laser or radio frequency procedures in the neck/chin area within 12 months of screening;
  3. History of botulinum toxin in the neck/chin area within 6 months of screening;
  4. Any skin conditions (including, but not limited to: skin infections, psoriasis, eczema, keloids, tattoos or hypertrophic or tethered scars) or history of trauma in the treatment area that may affect study procedures;
  5. A score of 4 (Extreme Laxity) on the Skin Laxity Assessment Scale at Visit 1 (Screening);
  6. Any known hypersensitivity to the study drug and/or any of the components;
  7. Prior or current enrollment in any Lithera/Neothetics sponsored LIPO-102/LIPO-202 study;
  8. Concurrently enrolled in another investigational drug or device study or used any experimental or investigational drug or device within 30 days of screening;
  9. Female subject who is pregnant or lactating;
  10. Any medical condition that in the opinion of the Investigator might complicate study procedures or assessments or jeopardize the subject's safety, including, but not limited to:

    1. any bleeding or connective tissue disorders;
    2. any clinically significant kidney or liver disease;
    3. any untreated thyroid disease;
    4. asthma, COPD, diabetes (Type I and II) or cardiovascular disease
    5. history of major surgery within 30 days prior to randomization, or planned surgery during the study period;
  11. Used drugs with anticoagulant activity (including aspirin) within 14 days prior to randomization, β adrenergic receptor agonists or blockers, strong CYP3A inhibitors, or nonpotassium sparing diuretics (e.g., loop or thiazide diuretics) within 28 days prior to randomization;
  12. Used tricyclic antidepressants or monoamine oxidase inhibitor medications within 14 days prior to randomization;
  13. Unlikely or unable to adhere to the study visit schedule or comply with protocol procedures.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03005717


Locations
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United States, California
Clinical Testing of Beverly Hills
Beverly Hills, California, United States, 90210
Ablon Skin Institute And Research Center
Manhattan Beach, California, United States, 90266
United States, Colorado
AboutSkin Research
Greenwood Village, Colorado, United States, 80113
United States, Florida
Skin Research Institute
Coral Gables, Florida, United States, 33146
United States, Michigan
Grekin Skin Institute
Warren, Michigan, United States, 48088
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, Missouri
Mercy Research
Washington, Missouri, United States, 63090
United States, Nebraska
Skin Specialists, PC
Omaha, Nebraska, United States, 68144
United States, New York
Juva Skin & Laser Center
New York, New York, United States, 10022
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Westlake Dermatology Clinical Research Center
Austin, Texas, United States, 78746
Sponsors and Collaborators
Neothetics, Inc
Investigators
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Study Chair: Daniel Piacquadio, MD Consultant, Therapeutics, Inc.
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Responsible Party: Neothetics, Inc
ClinicalTrials.gov Identifier: NCT03005717    
Other Study ID Numbers: LIPO-202-CL-31
First Posted: December 29, 2016    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Neothetics, Inc:
submental
Salmeterol Xinafoate
LIPO-202
bulge
Additional relevant MeSH terms:
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Salmeterol Xinafoate
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action