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NCT03510598 · ClinicalTrials.gov registry record · Phase 4
Submental Study (Sequential Treatment Approach)
A Phase 4 study of Body Fat Disorder, sponsored by Zeltiq Aesthetics.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT03510598: Completed Phase 4 study of Body Fat Disorder, sponsored by Zeltiq Aesthetics.
NCT03510598 is a Phase 4 study of Body Fat Disorder that has completed, run by Zeltiq Aesthetics. The registered enrollment target is 16 participants, below the 43-participant average among 3 other Body Fat Disorder trials with a reported enrollment target (63% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03510598, a Phase 4 study of Body Fat Disorder, has completed, sponsored by Zeltiq Aesthetics.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools.
Primary Outcome
The CR-SMFRS is a 5-point scale ranging from 0 to 5, with '0' = Absent Submental Convexity: no localized submental fat evident, '1' = Mild Submental Convexity: minimal localized submental fat, '2'= Moderate Submental Convexity: prominent, localized submental fat, '3' = Severe Submental Convexity: Marked, localized submental fat, '4' = Extreme Submental Convexity. The investigator performed the evaluation of each subject, including palpation of the neck and chin area; oblique anterior and profile
Conditions Studied
Interventions
- DEVICE The ZELTIQ CoolSculpting System
- DRUG Kybella 20 MG in 2 ML Injection
Study Locations (1)
California
- Rebecca Fitzgerald, MD Dermatology - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-03-27 |
| Est. Completion | 2018-12-08 |
| Phase | Phase 4 |
What the finished NCT03510598 record still lists
NCT03510598 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 43-participant average among 3 other Body Fat Disorder trials with a reported enrollment target (63% lower).
The record links to 1 condition, with Body Fat Disorder appearing as the primary indexed condition, and to 2 interventions - of which The ZELTIQ CoolSculpting System is the first listed.
NCT03510598 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03510598 about?
NCT03510598 is a clinical study titled "Submental Study (Sequential Treatment Approach)". Evaluate the safety and efficacy of subcutaneous fat layer reduction in the submental area using multiple therapeutic tools.
What is the current status of trial NCT03510598?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2018-03-27. Estimated completion is 2018-12-08.
What conditions does trial NCT03510598 study?
This clinical trial studies the following conditions: Body Fat Disorder.
What interventions are being tested in trial NCT03510598?
The interventions under investigation include: The ZELTIQ CoolSculpting System (DEVICE), Kybella 20 MG in 2 ML Injection (DRUG).
Who is sponsoring clinical trial NCT03510598?
This trial is sponsored by Zeltiq Aesthetics, which has 30 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03510598 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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