Submental Study (Sequential Treatment Approach)

Phase 4

Completed

• Conditions: Body Fat Disorder
• Interventions: Device: The ZELTIQ CoolSculpting System; Drug: Kybella 20 MG in 2 ML Injection

• Registration Number: NCT03510598
• Lead Sponsor: Zeltiq Aesthetics

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.

Study Timeline

• Study Start: 2018-03-27
• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-04-17
• Study First Posted: 2018-04-27
• Primary Completion: 2018-12-08
• Study Completion: 2018-12-08
• Status Verified: 2020-08
• Results First Submitted: 2021-11-01
• Results First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Results First Posted: 2021-12-30
• Last Update Posted: 2021-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella	The ZELTIQ CoolSculpting System	CoolSculpting followed by Kybella treatments. Kybella supplied in 2mL vials.
Treatment for Submental Fat Reduction withCoolSculpting System followed by Kybella	Kybella 20 MG in 2 ML Injection	CoolSculpting followed by Kybella treatments. Kybella supplied in 2mL vials.

Primary Outcome Measures

Name	Time	Method
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.	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.	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.	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 Outcome Measures

Name	Time	Method
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.	The SSRS is a 7-point scale with 0 = extremely dissatisfied 1= dissatisfied, 2 = slightly dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = slightly dissatisfied, 5 = satisfied, and 6 = extremely satisfied. The percentage of subjects reporting "slightly satisfied", "satisfied" or "extremely satisfied" is presented.
Change in Submental Fat Layer Thickness as Measured by Ultrasound.	12-week post-treatment follow-up visit.	Change in the fat layer thickness will be calculated by comparison of pre-treatment and 12 week post-final treatment ultrasound measurements taken in the area treated with the device. The Sponsor's standardized techniques for obtaining ultrasound imaging will be used. Overall fat layer thickness changes will be normalized for each subject by subtracting the change in the pre-treatment area from the change in treated area to remove the influence of weight variations. This result is considered the treatment effect. Results indicate the fat layer reduction in centimeters.

Trial Locations

Locations (1)

Rebecca Fitzgerald, MD Dermatology; 🇺🇸 Los Angeles, California, United States