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

Status: Completed

Location: See all (11) locations...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 2

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 55

Healthy Volunteers: f

View:

• Healthy males or non-pregnant females;

• Capable of providing written, informed consent; and ,

• Have submental bulging that is evaluated by the Investigator as Moderate or Large.

Locations

United States

California

Clinical Testing of Beverly Hills

Beverly Hills

Ablon Skin Institute And Research Center

Manhattan Beach

Colorado

AboutSkin Research

Greenwood Village

Florida

Skin Research Institute

Coral Gables

Michigan

Grekin Skin Institute

Warren

Minnesota

Minnesota Clinical Study Center

Fridley

Missouri

Mercy Research

Washington

Nebraska

Skin Specialists, PC

Omaha

New York

Juva Skin & Laser Center

New York

Tennessee

Tennessee Clinical Research Center

Nashville

Texas

Westlake Dermatology Clinical Research Center

Austin

Time Frame

Start Date: 2016-12-22

Completion Date: 2017-06-02

Participants

Target number of participants: 162

Treatments

Experimental: Active High

Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.2 mcg SX/mL Total Weekly Dose: up to 3.0 mcg SX

Experimental: Active Low

Drug: LIPO 202 (Salmeterol Xinafoate for Injection), 0.02 mcg SX/mL Total Weekly Dose: up to 0.3 mcg SX

Placebo_comparator: Placebo

Placebo for LIPO 202 (Salmeterol Xinafoate for Injection)

Authors

Leroy Young, Glynis Ablon, Joel Schlessinger, Steven Grekin, Vernon L Young, Michael H Gold, Daniel Friedmann, Bruce Katz, John Joseph, Steven Kempers, Joely Kaufman

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

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