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

Completed · Phase 2 · Has a placebo group

Conditions studied: Submental Fat

In brief

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.

Key facts

Study ID

NCT03005717

Run by

Neothetics, Inc

People needed

162

Starts

2016-12-22

Expected to finish

2017-06-02

Last updated by the study team

2017-10-20

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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".

You may not qualify if…

• History of prior treatment to reduce submental bulging;
• History of derm fillers, chemical peels, or laser or radio frequency procedures in the neck/chin area within 12 months of screening;
• History of botulinum toxin in the neck/chin area within 6 months of screening;
• 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;
• A score of 4 (Extreme Laxity) on the Skin Laxity Assessment Scale at Visit 1 (Screening);
• Any known hypersensitivity to the study drug and/or any of the components;
• Prior or current enrollment in any Lithera/Neothetics sponsored LIPO-102/LIPO-202 study;
• Concurrently enrolled in another investigational drug or device study or used any experimental or investigational drug or device within 30 days of screening;
• Female subject who is pregnant or lactating;
• 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:
• any bleeding or connective tissue disorders;
• any clinically significant kidney or liver disease;
• any untreated thyroid disease;
• asthma, COPD, diabetes (Type I and II) or cardiovascular disease
• history of major surgery within 30 days prior to randomization, or planned surgery during the study period;
• 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;
• Used tricyclic antidepressants or monoamine oxidase inhibitor medications within 14 days prior to randomization;
• Unlikely or unable to adhere to the study visit schedule or comply with protocol procedures.

Where it is running

• Clinical Testing of Beverly Hills — Beverly Hills, California, United States
• Ablon Skin Institute And Research Center — Manhattan Beach, California, United States
• AboutSkin Research — Greenwood Village, Colorado, United States
• Skin Research Institute — Coral Gables, Florida, United States
• Grekin Skin Institute — Warren, Michigan, United States
• Minnesota Clinical Study Center — Fridley, Minnesota, United States
• Mercy Research — Washington, Missouri, United States
• Skin Specialists, PC — Omaha, Nebraska, United States
• Juva Skin & Laser Center — New York, New York, United States
• Tennessee Clinical Research Center — Nashville, Tennessee, United States
• Westlake Dermatology Clinical Research Center — Austin, Texas, United States

Full record on ClinicalTrials.gov

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