Trial Outcomes & Findings for CoolSculpting and RF for the Submental (NCT NCT03873779)

Results Overview

UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

From date of first treatment to 12 weeks after final treatment (up to 24 weeks)

Results posted on

2025-03-10

Participant Flow

A separate cohort was initially planned for radiofrequency treatment immediately following cryolipolysis at the same visit, however no participants were enrolled in this cohort.

Participant milestones

Participant milestones
Measure	Cryolipolysis Followed by Radiofrequency Treatment Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Overall Study STARTED	8
Overall Study Received Cryolipolysis Treatment	8
Overall Study Received Radiofrequency Treatment	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cryolipolysis Followed by Radiofrequency Treatment Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

CoolSculpting and RF for the Submental

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cryolipolysis Followed by Radiofrequency Treatment n=8 Participants Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	3 Participants n=5 Participants
Race/Ethnicity, Customized Other	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: From date of first treatment to 12 weeks after final treatment (up to 24 weeks)

Population: The Safety Population consisted of all participants who received at least one study treatment.

UADEs were defined as any serious adverse effect on health and safety or any life-threatening problem or death caused by, or associated with a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants.

Outcome measures

Outcome measures
Measure	Cryolipolysis Followed by Radiofrequency Treatment n=8 Participants Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Number of Participants With Unanticipated Adverse Device Effects (UADEs)	0 Participants

PRIMARY outcome

Timeframe: Baseline, 12 weeks post radiofrequency treatment

Population: The Per-protocol population (PP) consisted of all participants who received both CoolSculpting and radiofrequency treatment, and had a weight change of no more than 5 percent at the time of the 12-week post final treatment visit.

Photos obtained during the study were reviewed by an independent physician reviewer who entered assessments according to the Global Aesthetic Improvement Scale (GAIS). The GAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who were assessed as improved ("Very Much Improved," "Much Improved", and "Improved").

Outcome measures

Outcome measures
Measure	Cryolipolysis Followed by Radiofrequency Treatment n=6 Participants Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)	2 Participants

SECONDARY outcome

Timeframe: Baseline, 12 weeks post radiofrequency treatment

Population: The PP population consisted of all participants who received both CoolSculpting and radiofrequency treatment, and had a weight change of no more than 5 percent at the time of the 12-week post final treatment visit.

Fat layer thickness was measured using a caliper at the center of the treatment area.

Outcome measures

Outcome measures
Measure	Cryolipolysis Followed by Radiofrequency Treatment n=6 Participants Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Percent Change From Baseline in Fat Layer Thickness	-31.9 percent change Standard Deviation 9.4

SECONDARY outcome

Timeframe: Baseline, 12 weeks post radiofrequency treatment

Population: The PP population consisted of all participants who received both CoolSculpting and radiofrequency treatment, and had a weight change of no more than 5 percent at the time of the 12-week post final treatment visit.

Participants rated improvement in their treatment areas based on the SGAIS. The SGAIS had outcome choices of "very much improved", "much improved", "improved", "no change", "worse", "much worse", or "very much worse", with "very much improved" representing the most aesthetic improvement. Reported here is the sum of participants who reported as improved ("Very Much Improved," "Much Improved", and "Improved").

Outcome measures

Outcome measures
Measure	Cryolipolysis Followed by Radiofrequency Treatment n=6 Participants Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Number of Participants With Improvement Based on Subject-graded Global Aesthetic Improvement Scale (SGAIS)	6 Participants

SECONDARY outcome

Timeframe: Baseline, 12 weeks post radiofrequency treatment

Population: The PP population consisted of all participants who received both CoolSculpting and radiofrequency treatment, and had a weight change of no more than 5 percent at the time of the 12-week post final treatment visit.

Participants assessed their own satisfaction with their face and chin using the SSRS. The SSRS is a participants self-rating scale, scored on a 7-point scale with 0=extremely dissatisfied, 1=dissatisfied, 2=slightly dissatisfied, 3=neither satisfied nor dissatisfied, 4=slightly satisfied, 5=satisfied, and 6=extremely satisfied, with 6 representing higher participant satisfaction. Reported here is the number of participants with a score of 4 or higher, indicating satisfaction.

Outcome measures

Outcome measures
Measure	Cryolipolysis Followed by Radiofrequency Treatment n=6 Participants Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Number of Participants With Positive Response in Subject Self-Rating Scale (SSRS) Score	5 Participants

SECONDARY outcome

Timeframe: Baseline, 12 Weeks Post Radiofrequency Treatment

Population: The Per-protocol population consisted of all participants who received at least 1 study treatment and had a weight change of no more than 5 percent at the time of the 12-week post final treatment visit.

Participants reported their satisfaction with aspects of treatment on a written questionnaire which included a 5-point Likert scale ranging from -2 to 2, with -2 representing more negative response and 2 representing more positive response. Reported here are the numbers of participants with responses of 1 or 2, indicating a positive response, to the following categories: Comfort of Treatment Procedure, How Visible is Fat Reduction, Overall Effect from the Procedure, Overall Satisfaction with Treatment from the Procedure to the Result, Made Me Look More Youthful, Made My Chin Look More Toned, Feel Less Self-Conscious About Chin Fat, Overall Appearance Has Improved.

Outcome measures

Outcome measures
Measure	Cryolipolysis Followed by Radiofrequency Treatment n=6 Participants Participants received cryolipolysis treatment in submental and submandibular areas using the CoolSculpting System and CoolMini applicator for fat layer reduction on Day 0, which was followed with a radiofrequency treatment performed 12 weeks after CoolSculpting.
Number of Participants With Positive Response on Subject Satisfaction Questionnaire Comfort of Treatment Procedure	3 Participants
Number of Participants With Positive Response on Subject Satisfaction Questionnaire How Visible is Fat Reduction	4 Participants
Number of Participants With Positive Response on Subject Satisfaction Questionnaire Overall Effect from the Procedure	3 Participants
Number of Participants With Positive Response on Subject Satisfaction Questionnaire Overall Satisfaction with Treatment, from the Procedure to the Result	5 Participants
Number of Participants With Positive Response on Subject Satisfaction Questionnaire Made Me Look More Youthful	4 Participants
Number of Participants With Positive Response on Subject Satisfaction Questionnaire Made My Chin Look More Toned	4 Participants
Number of Participants With Positive Response on Subject Satisfaction Questionnaire Feel Less Self-Conscious About Chin Fat	4 Participants
Number of Participants With Positive Response on Subject Satisfaction Questionnaire Overall Appearance Has Improved	4 Participants

Adverse Events

Cryolipolysis Followed by Radiofrequency Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sally Hallas, RN, Director Clinical Development - Body Contouring

Zeltiq

Phone: 209-294-5571

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Publication restrictions are in place

Restriction type: OTHER