Trial Outcomes & Findings for CoolSculpting Treatment in the Upper Arms (NCT NCT02939105)

Last Updated: 2021-06-09

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. Reviewers are practicing dermatologists or plastic surgeons. All reviewers will be blinded to post-treatment vs. baseline untreated area. The order in which images are 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. Criteria for evaluable photos for the purposes of the independent review: subject completed treatment regimen; subject has complete set of baseline photos; subject has a complete set of post-treatment photos; photos were taken using Zeltiq standard procedure. The expected success rate is 70% correct identification by 2 out of 3 reviewers.

Recruitment status

COMPLETED

Study phase

Target enrollment

15 participants

Primary outcome timeframe

12 weeks post-final treatment

Results posted on

2021-06-09

Participant Flow

Subjects seeking a reduction in upper arm fat were recruited from the general population.

Participant milestones

Participant milestones
Measure	CoolSculpting Intervention Group The CoolSculpting System was used in the study. The study was designed to evaluate the safety and effectiveness of cryolypolysis for non-invasive reduction of upper arm fat.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

CoolSculpting Treatment in the Upper Arms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CoolSculpting Intervention Group n=15 Participants Subjects treated with CoolSculpting System for Arm Fat
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	51.1 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment Canada	15 participants n=5 Participants
Body Mass Index (BMI)	26.8 kg/m^2 n=5 Participants
Fitzpatrick Skin Type FST I -always burns, never tans	0 participants in skin type category n=5 Participants
Fitzpatrick Skin Type FST II- burns easily, tans poorly	9 participants in skin type category n=5 Participants
Fitzpatrick Skin Type FST III- tans after initial burn	4 participants in skin type category n=5 Participants
Fitzpatrick Skin Type FST IV - burns minimally, tans easily	0 participants in skin type category n=5 Participants
Fitzpatrick Skin Type FST V- rarely burns, tans darkly easily	2 participants in skin type category n=5 Participants
Fitzpatrick Skin Type FST VI- never burns	0 participants in skin type category n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks post-final treatment

Population: The analysis population included subjects with baseline and post-treatment photos.

Outcome measures

Outcome measures
Measure	CoolSculpting Intervention Group n=30 photos Subjects treated with CoolSculpting for arm fat
Proportion of Correctly Identified Pre-treatment Photos	26 photos

PRIMARY outcome

Timeframe: Enrollment through12 weeks post-final treatment

Population: Each adverse event occurring in the per-protocol population of 15 subjects was evaluated by investigators for any relationship to the study device or procedure.

The primary safety endpoint of the study is the incidence of unanticipated adverse device effects (UADE) reported in the study period. Investigators assessed each adverse event to determine if there was relationship to the study device or procedure. Adverse event data are collected from the time of study enrollment through the final follow-up visit at 12 weeks post-treatment.

Outcome measures

Outcome measures
Measure	CoolSculpting Intervention Group n=15 Participants Subjects treated with CoolSculpting for arm fat
Number of Participants With Unanticipated Adverse Device Effects (UADE) Associated With the CoolSculpting System and Vacuum Applicators in the Upper Arms	0 number of participants with UADE

Adverse Events

CoolSculpting Intervention Group

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

Kerrie Jiang, Sr. 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