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Submental Study (Sequential Treatment Approach)

NCT03510598 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-12-30

Study results available
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Summary

Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools.

Conditions

  • Body Fat Disorder

Interventions

DEVICE

The ZELTIQ CoolSculpting System

The CoolSculpting machine will be used to perform the treatments.

DRUG

Kybella 20 MG in 2 ML Injection

Injectable drug called KYBELLA® (deoxycholic acid)

Sponsors & Collaborators

  • Zeltiq Aesthetics

    lead INDUSTRY

Principal Investigators

  • Kerrie Jiang, NP · Zeltiq Aesthetics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-27
Primary Completion
2018-12-08
Completion
2018-12-08
FDA Drug
Yes
FDA Device
Yes

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 NCT03510598 on ClinicalTrials.gov