Fat Reduction in the Submental Area - a Sequential Treatment Approach With CoolMini and KYBELLA®
Overview
- Phase
- Phase 4
- Intervention
- The ZELTIQ CoolSculpting System
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- The Proportion of Subjects Who Have at Least a 1-grade Improvement on the Clinician Reported Submental Fat Rating Scale (CR-SMFRS) at the Final Follow-up Visit When Compared to the Baseline Grade.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella
CoolSculpting followed by Kybella treatments. Kybella supplied in 2mL vials.
Intervention: The ZELTIQ CoolSculpting System
Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella
CoolSculpting followed by Kybella treatments. Kybella supplied in 2mL vials.
Intervention: Kybella 20 MG in 2 ML Injection
Outcomes
Primary Outcomes
The Proportion of Subjects Who Have at Least a 1-grade Improvement on the Clinician Reported Submental Fat Rating Scale (CR-SMFRS) at the Final Follow-up Visit When Compared to the Baseline Grade.
Time Frame: Baseline and 12-week post-treatment follow-up visit.
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 views of the chin and neck; and observation of pronation, supination and lateral movement of the head. The score was determined during a live assessment while the subject's head was in the Frankfort plane posture and was recorded as a whole number.
The Proportion of Subjects for Whom a 2-grade Improvement Was Recorded Using the CR-SMFRS From Baseline to Final Follow-uo Visit.
Time Frame: Baseline and 12-week post-treatment follow-up visit.
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 views of the chin and neck; and observation of pronation, supination and lateral movement of the head. The score was determined during a live assessment while the subject's head was in the Frankfort plane posture and was recorded as a whole number.
The Number of Device, Drug or Procedure-related Adverse Events.
Time Frame: 12-week post-treatment follow-up visit, approximately 31 weeks from enrollment.
Adverse event information is collected from the time of study enrollment to the completion of the final follow-up visit. Investigators determined if adverse events occurring in the study are 'Not Related', 'Possibly Related', 'Probably Related', or have a 'Causal" relationship to the study device, drug or procedure.
Secondary Outcomes
- Subject Satisfaction as Measured by a Comparison of Baseline and 12-weeks Post-final Treatment of Completed Subject Self-Rating Scales (SSRS).(Baseline and 12-weeks post- final treatment visit.)
- Change in Submental Fat Layer Thickness as Measured by Ultrasound.(12-week post-treatment follow-up visit.)