Trial Outcomes & Findings for Submental Study (Sequential Treatment Approach) (NCT NCT03510598)

NCT ID: NCT03510598

Last Updated: 2021-12-30

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 16 participants
• Primary outcome timeframe: Baseline and 12-week post-treatment follow-up visit.
• Results posted on: 2021-12-30

Participant Flow

Participant milestones

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
Overall Study STARTED	16
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Submental Study (Sequential Treatment Approach)

Baseline characteristics by cohort

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n=16 Participants All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	16 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants
Race/Ethnicity, Customized African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants
BMI	31.8 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12-week post-treatment follow-up visit.

Population: Of the 16 subjects enrolled in the study, 1 subject withdrew after the first CoolSculpting treatment, an another subject was excluded from the efficacy analysis due to failure to maintain weight according to protocol requirements.

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.

Outcome measures

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n=14 Participants All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
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.	14 Participants

PRIMARY outcome

Timeframe: Baseline and 12-week post-treatment follow-up visit.

Population: Of the 16 subjects enrolled in the study, 1 subject withdrew from the study after the first CoolSculpting treatment. A second subject was excluded from the efficacy analysis for weight change outside of the range specified in the study protocol.

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.

Outcome measures

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n=14 Participants All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
The Proportion of Subjects for Whom a 2-grade Improvement Was Recorded Using the CR-SMFRS From Baseline to Final Follow-uo Visit.	10 Participants

PRIMARY outcome

Timeframe: 12-week post-treatment follow-up visit, approximately 31 weeks from enrollment.

Population: All adverse events for all subjects treated with CoolSculpting or CoolSculpting and Kybella were evaluated for the relationship to the device, the drug or the study procedure.

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.

Outcome measures

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n=16 Participants All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
The Number of Device, Drug or Procedure-related Adverse Events.	90 adverse events

SECONDARY outcome

Timeframe: 12-week post-treatment follow-up visit.

Population: Of the 16 subjects enrolled and treated, 1 subject withdrew from the study after the first CoolSculpting treatment. A second subject was excluded from the efficacy analysis for weight gain outside of protocol requirements.

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.

Outcome measures

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n=14 Participants All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
Change in Submental Fat Layer Thickness as Measured by Ultrasound.	0.02 centimeters Standard Deviation 0.13

SECONDARY outcome

Timeframe: Baseline and 12-weeks post- final treatment visit.

Population: Of the 16 subjects enrolled and treated in the study, 1 subject withdrew from the study after the first CoolSculpting treatment. Another subject was excluded from this efficacy analysis for weight gain outside requirements defined in the study protocol.

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.

Outcome measures

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n=14 Participants All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
Subject Satisfaction as Measured by a Comparison of Baseline and 12-weeks Post-final Treatment of Completed Subject Self-Rating Scales (SSRS).	71.4 percent of participants Interval 41.9 to 91.6

Adverse Events

Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Treatment for Submental Fat Reduction Using Zeltiq CoolSculpting System Followed by Kybella n=16 participants at risk All subjects enrolled in the study were to receive 2 CoolSculpting sessions in which submental fat was treated. Six weeks following the final CoolSculpting session, subjects were treated with Kybella in the submental area.
Skin and subcutaneous tissue disorders Erythema/purpura	93.8% 15/16 • Number of events 28 • Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.
Skin and subcutaneous tissue disorders Edema	93.8% 15/16 • Number of events 29 • Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.
Skin and subcutaneous tissue disorders Numbness	93.8% 15/16 • Number of events 25 • Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.
Skin and subcutaneous tissue disorders Numbness and tingling	25.0% 4/16 • Number of events 4 • Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.
Skin and subcutaneous tissue disorders Bruising	25.0% 4/16 • Number of events 4 • Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.
Musculoskeletal and connective tissue disorders Back pain	6.2% 1/16 • Number of events 1 • Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.
Renal and urinary disorders Urinary tract infection	6.2% 1/16 • Number of events 1 • Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.
Musculoskeletal and connective tissue disorders Foot sprain	6.2% 1/16 • Number of events 1 • Adverse event data were collected from the time of enrollment through the final 12-week post-treatment follow-up visit. The final follow-up visit timing was predicated on the number of Kybella treatment sessions each subject completed. The range for the final follow-up visit was from 28 to 31 weeks.

Additional Information

Lori Brandt, Director Clinical Trial Management

Zeltiq Aesthetics

Phone: 925 621-7460

Email: lori.brandt@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place