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

NCT03005717 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2017-10-20

No results posted yet for this study

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.

Conditions

  • Submental Fat

Interventions

DRUG

LIPO-202

DRUG

Placebo for LIPO-202

Lyophile manufactured to mimic LIPO-202 lyophile.

Sponsors & Collaborators

  • Neothetics, Inc

    lead INDUSTRY

Principal Investigators

  • Daniel Piacquadio, MD · Consultant, Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-22
Primary Completion
2017-06-02
Completion
2017-06-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03005717 on ClinicalTrials.gov