Trials / Completed
CompletedNCT03510598
Submental Study (Sequential Treatment Approach)
Fat Reduction in the Submental Area - a Sequential Treatment Approach With CoolMini and KYBELLA®
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- Zeltiq Aesthetics · Industry
- Sex
- All
- Age
- 22 Years – 65 Years
- Healthy volunteers
- Accepted
Summary
Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools.
Detailed description
The Zeltiq CoolSculpting System and the sequential use of the injectable drug Kybella for non-invasive and then minimally invasive fat reduction in the submental area will be evaluated during the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2018-03-27
- Primary completion
- 2018-12-08
- Completion
- 2018-12-08
- First posted
- 2018-04-27
- Last updated
- 2021-12-30
- Results posted
- 2021-12-30
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03510598. Inclusion in this directory is not an endorsement.