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

October 18, 2017 updated by: Neothetics, Inc

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

162

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Beverly Hills, California, United States, 90210
        • Clinical Testing of Beverly Hills
      • Manhattan Beach, California, United States, 90266
        • Ablon Skin Institute and Research Center
    • Colorado
      • Greenwood Village, Colorado, United States, 80113
        • AboutSkin Research
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Skin Research Institute
    • Michigan
      • Warren, Michigan, United States, 48088
        • Grekin Skin Institute
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • Missouri
      • Washington, Missouri, United States, 63090
        • Mercy Research
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialists, PC
    • New York
      • New York, New York, United States, 10022
        • Juva Skin & Laser Center
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Austin, Texas, United States, 78746
        • Westlake Dermatology Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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
Other Names:
  • 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
Other Names:
  • Salmeterol Xinafoate for Injection
Placebo Comparator: Placebo
Placebo for LIPO 202 (Salmeterol Xinafoate for Injection)
Lyophile manufactured to mimic LIPO-202 lyophile.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as measured by number of subjects with adverse events.
Time Frame: 12 weeks (Baseline through 4 weeks post last dose)
12 weeks (Baseline through 4 weeks post last dose)
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)
12 weeks (Baseline through 4 weeks post last dose)
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.
12 weeks (Baseline through 4 weeks post last dose)
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.
12 weeks (Baseline through 4 weeks post last dose)
Change in submental fat thickness measured with calipers (mm).
Time Frame: 12 weeks (Baseline through 4 weeks post last dose)
12 weeks (Baseline through 4 weeks post last dose)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Chair: Daniel Piacquadio, MD, Consultant, Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2016

Primary Completion (Actual)

June 2, 2017

Study Completion (Actual)

June 2, 2017

Study Registration Dates

First Submitted

December 21, 2016

First Submitted That Met QC Criteria

December 23, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 18, 2017

Last Verified

October 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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