Trial Outcomes & Findings for Cryolipolysis for Jawline Contouring (NCT NCT03352141)

NCT ID: NCT03352141

Last Updated: 2025-07-23

Results Overview

This outcome measurement considered all unanticipated device- or procedure-related adverse effects.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Enrollment through study completion, an average of 6 months.
• Results posted on: 2025-07-23

Participant Flow

Participant milestones

Measure	CoolSculpting for Jawline Contouring All enrolled participants will be treated with the Zeltiq CoolSculpting System in the jawline area. Each participant will have up to 2 treatments, treatments 6 weeks apart.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cryolipolysis for Jawline Contouring

Baseline characteristics by cohort

Measure	CoolSculpting for Jawline Contouring n=15 Participants All enrolled participants will be treated with the Zeltiq CoolSculpting System in the jawline area. Each participant will have up to 2 treatments, treatments 6 weeks apart.
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	50.9 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race/Ethnicity, Customized Am Indian or Alaska Native	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pac Islander	0 Participants n=5 Participants
Race/Ethnicity, Customized White	13 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants
Region of Enrollment Canada	15 participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment through study completion, an average of 6 months.

Population: All 15 enrolled subjects were evaluated by the study investigator for unanticipated adverse device effects throughout the duration of the study.

This outcome measurement considered all unanticipated device- or procedure-related adverse effects.

Outcome measures

Measure	CoolSculpting for Jawline Contouring n=15 Participants All enrolled participants will be treated with the Zeltiq CoolSculpting System in the jawline area. Each participant will have up to 2 treatments, treatments 6 weeks apart.	Submandibular Ultrasound Measurement (LEFT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Submandibular Ultrasound Measurement (RIGHT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Jowl Ultrasound Measurement (LEFT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Jowl Ultrasound Measurement (RIGHT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.
Number of Participants With Unanticipated Adverse Device Effects (UADE)	0 Participants with UADE reported	—	—	—	—

PRIMARY outcome

Timeframe: Baseline through 12 weeks post second treatment.

Population: Fourteen (14) of the enrolled subjects were included in the analysis of efficacy. One (1) subject was excluded due to body weight outside the requirements of the protocol.

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 (baseline) 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 photographs will be presented will be randomized; for each subject placement of the baseline and 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 75% correct identification of pre-treatment photos by 2 out of 3 reviewers.

Outcome measures

Measure	CoolSculpting for Jawline Contouring n=14 Photograph Pairs All enrolled participants will be treated with the Zeltiq CoolSculpting System in the jawline area. Each participant will have up to 2 treatments, treatments 6 weeks apart.	Submandibular Ultrasound Measurement (LEFT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Submandibular Ultrasound Measurement (RIGHT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Jowl Ultrasound Measurement (LEFT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Jowl Ultrasound Measurement (RIGHT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.
Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers	8 Number Photo Pairs Correctly Identified	—	—	—	—

SECONDARY outcome

Timeframe: Baseline and 12 weeks post-final treatment.

Population: Fourteen (14) subjects were included in the efficacy analysis; one (1) subject was excluded due to weight change outside of the requirements of the protocol.

When compared to baseline ultrasound imaging, the change in fat layer thickness at the final post-treatment visit will be measured. Ultrasound measurements were obtained in 5 areas intended for treatment at the baseline visit. A template was created for identification of the locations for subsequent measurements using external landmarks (e.g. skin imperfections) as reference points. The Treatment Effect = Follow-Up Average Thickness - Baseline Average Thickness. A negative change reflects a decrease in the average thickness from the baseline visit to the follow-up visit, and a positive result reflects an increase.

Outcome measures

Measure	CoolSculpting for Jawline Contouring n=14 Participants All enrolled participants will be treated with the Zeltiq CoolSculpting System in the jawline area. Each participant will have up to 2 treatments, treatments 6 weeks apart.	Submandibular Ultrasound Measurement (LEFT) n=14 Participants Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Submandibular Ultrasound Measurement (RIGHT) n=14 Participants Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Jowl Ultrasound Measurement (LEFT) n=14 Participants Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Jowl Ultrasound Measurement (RIGHT) n=14 Participants Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.
Change in Fat Layer in the Treated Jawline Area	-0.14 cm Standard Deviation 0.12	-0.10 cm Standard Deviation 0.11	-0.10 cm Standard Deviation 0.11	-0.08 cm Standard Deviation 0.07	-0.03 cm Standard Deviation 0.05

SECONDARY outcome

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

Population: Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.

Subject satisfaction with the CoolSculpting procedure will be assessed by a questionnaire administered at the 12-week post-final treatment follow-up visit. The questionnaire will consist of 5-point Likert questions with 1 = very dissatisfied; 2 = dissatisfied; 3 = not sure; 4 = satisfied and 5 = very satisfied. Positive responses (very satisfied and satisfied) will be reported.

Outcome measures

Measure	CoolSculpting for Jawline Contouring n=14 Participants All enrolled participants will be treated with the Zeltiq CoolSculpting System in the jawline area. Each participant will have up to 2 treatments, treatments 6 weeks apart.	Submandibular Ultrasound Measurement (LEFT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Submandibular Ultrasound Measurement (RIGHT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Jowl Ultrasound Measurement (LEFT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.	Jowl Ultrasound Measurement (RIGHT) Fourteen subjects were included in the efficacy analysis. One subject was excluded due to weight change outside the requirements of the protocol.
Overall Satisfaction With the Treatment	9 Participants	—	—	—	—

Adverse Events

CoolSculpting for Jawline Contouring

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	CoolSculpting for Jawline Contouring n=15 participants at risk All enrolled participants will be treated with the Zeltiq CoolSculpting System in the jawline area. Each participant will have up to 2 treatments, treatments 6 weeks apart.
Skin and subcutaneous tissue disorders Prolonged bruising	6.7% 1/15 • Number of events 1 • Adverse event data were collected from the time of enrollment through the final 12-week post-final treatment follow-up visit, an average of 6 months.
Skin and subcutaneous tissue disorders Prolonged edema	13.3% 2/15 • Number of events 5 • Adverse event data were collected from the time of enrollment through the final 12-week post-final treatment follow-up visit, an average of 6 months.

Additional Information

Lori Brandt, Director Cinical 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