Trial Outcomes & Findings for Fat Reduction in the Submandibular/Submental Area (NCT NCT02700165)

Last Updated: 2021-11-16

Results Overview

Change in the treated vs. untreated areas will be assessed by observation of changes in surface contour and/or fat volume by an independent photo review of pre-treatment and post-treatment images of the treated areas. Reviewers will be practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images will be presented will be randomized; for each subject placement of the baseline, pre-treatment image will be randomized for each pair of subject images. Reviewers will be asked to select the baseline photos for each subject photo series and record selections on a data collection form. Success is defined as 70% correct identification of pre-treatment images by at least 70% correct identification of pre-treatment images by two out of three reviewers.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

Baseline (pre-treatment) and 12 weeks post treatment

Results posted on

2021-11-16

Participant Flow

Subjects seeking reduction of fat in the submental and submandibular area were recruited from the general population.

Participant milestones

Participant milestones
Measure	CoolSculpting With CoolMini Applicator for Fat Reduction in the Chin Per protocol, subjects were permitted to receive up to 3 CoolSculpting treatments on the submental and submandibular area at each of two treatment sessions spaced 6 weeks apart. At each treatment session, subjects were treated with the CoolSculpting device programmed for a specified protocol-defined time and temperature. All subjects received 2 cooling cycles at the first treatment session. At the second treatment visit, 12 subjects received 2 cooling cycles and 2 received 1 cycle.
Overall Study STARTED	14
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fat Reduction in the Submandibular/Submental Area

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CoolSculpting With CoolMini Applicator n=14 Participants ZELTIQ CoolSculpting System Treatment Group
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	50.5 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	12 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Region of Enrollment United States	14 Participants n=5 Participants
Body Mass Index	33.1 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-treatment) and 12 weeks post treatment

Population: All subjects were included in the analysis population.

Outcome measures

Outcome measures
Measure	CoolSculpting With CoolMini Applicator n=14 photos ZELTIQ CoolSculpting System Treatment Group
Proportion of Accurately Identified Pre-Treatment Photos by a Panel of Blinded Independent Reviewers	11 photos

PRIMARY outcome

Timeframe: Enrollment through the 12 week final follow-up visit

Population: The per-protocol population of 14 subjects was analyzed.

The primary safety endpoint is the count of unanticipated adverse device effects (UADEs) reported in the study period. It is expected there will be zero UADEs.

Outcome measures

Outcome measures
Measure	CoolSculpting With CoolMini Applicator n=14 Participants ZELTIQ CoolSculpting System Treatment Group
The Number of Unanticipated Adverse Device Effects (UADE) Reported	0 UADEs

SECONDARY outcome

Timeframe: Baseline and 12 week post-treatment

Caliper measurements will be collected prior to treatment (pre-treatment) and at the 12-week follow-up visit. The caliper measurement process involves pinching the tissue within the treatment area in order to obtain the measurement, thereby folding the tissue and doubling the fat layer thickness. Measurements were taken with subjects standing in a neutral position. Measured values (mm) will be halved to reflect single fat layer change and will not take into account the fold of tissue during the measurement process. The fat layer measured pre-treatment will be compared to the 12-week post-treatment measurement.

Outcome measures

Outcome measures
Measure	CoolSculpting With CoolMini Applicator n=14 Participants ZELTIQ CoolSculpting System Treatment Group
Change in Fat Layer Thickness of the Submental Area as Measured by Caliper	-2.3 millimeters fat layer change Standard Deviation 0.8

SECONDARY outcome

Timeframe: 12 weeks post-treatment

Population: The per-protocol population of 14 subjects was included the analysis group.

Subject satisfaction as assessed by questionnaires administered at 12 weeks. Subjects will be asked to determine overall satisfaction with the treatment using a 5-point scale and free-text response options on a questionnaire. The choice options will be 1 = very dissatisfied, 2- dissatisfied, 3 - not sure, 4- satisfied and 5- very satisfied. Positive responses to questionnaire statements (score 4 or 5) will be used to assess satisfaction with the CoolSculpting procedure.

Outcome measures

Outcome measures
Measure	CoolSculpting With CoolMini Applicator n=14 Participants ZELTIQ CoolSculpting System Treatment Group
Subject Satisfaction Agree/strongly agree appearance improved	11 Participants
Subject Satisfaction Procedure comfortable/very comfortable	7 Participants
Subject Satisfaction Visible fat/very visible fat reduction	10 Participants
Subject Satisfaction Agree/strongly agree appearance more youthful	9 Participants
Subject Satisfaction Agree/strongly agree chin looked more toned	12 Participants
Subject Satisfaction Agree/strongly agree less self-conscious of chin	11 Participants
Subject Satisfaction Agree/strongly agree result was as expected	11 Participants
Subject Satisfaction Satisfied/very satisfied with CoolSculpting	13 Participants
Subject Satisfaction Would recommend procedure to a friend	13 Participants

Adverse Events

CoolSculpting With CoolMini Applicator

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	CoolSculpting With CoolMini Applicator n=14 participants at risk The ZELTIQ CoolSculpting System Treatment Group
Musculoskeletal and connective tissue disorders Hip Replacement	7.1% 1/14 • Number of events 1 • Adverse event data was collected from enrollment through the 12 week final follow-up visit.

Other adverse events

Other adverse events
Measure	CoolSculpting With CoolMini Applicator n=14 participants at risk The ZELTIQ CoolSculpting System Treatment Group
Skin and subcutaneous tissue disorders Rash on face and neck	7.1% 1/14 • Number of events 1 • Adverse event data was collected from enrollment through the 12 week final follow-up visit.
Surgical and medical procedures Ear pain	7.1% 1/14 • Number of events 1 • Adverse event data was collected from enrollment through the 12 week final follow-up visit.
General disorders Tongue tingling	7.1% 1/14 • Number of events 1 • Adverse event data was collected from enrollment through the 12 week final follow-up visit.

Additional Information

Kerrie Jiang, Exective Director, Regulatory, Clinical and Medical Affairs

Zeltiq Aesthetics

Phone: (925) 621-7462

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place