Body Fat Disorder
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of non-invasive reduction of subcutaneous fat along the jawline with Cryolipolysis.
Interventions
DEVICEThe ZELTIQ System
The CoolSculpting machine will be used to perform the treatments.
Sponsors
Zeltiq Aesthetics
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or female subjects \> 22 years of age and \< 65 years of age. * Treatment area skin fold thickness \> 1cm (measured by caliper). * Sufficient treatment area requiring at least 2 cooling cycles. * No weight change exceeding 5% of body weight in the preceding month. * Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study. * Subject has signed a written informed consent form.
Exclusion criteria
* Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result. * Prominent platysmal bands at rest which may interfere with assessment of treatment area. * Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands. * Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands. * Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the treatment area (below the mandible) within the past 6 months. * Botulinum toxin or other aesthetic drug injections within the treatment area in the past 6 months. * History of facial nerve paresis or paralysis (such as Bell's palsy). * History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment. * History of prior neck surgery, or prior surgery in the area of intended treatment. * Current infection in and adjacent to treatment area. * Known history of cryoglobulinemia, cold urticaria, cold agglutinin disease or paroxysmal cold hemoglobinuria. * Known history of Raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. * History of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. * Currently taking or has taken diet pills or weight control supplements within the past month. * Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation. * Active implanted device such as a pacemaker, defibrillator, or drug delivery system. * Pregnant or intending to become pregnant in the next 6 months. * Lactating or has been lactating in the past 6 months. * Unable or unwilling to comply with the study requirements. * Currently enrolled in a clinical study of an unapproved investigational drug or device. * Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Unanticipated Adverse Device Effects (UADE) | Enrollment through study completion, an average of 6 months. | This outcome measurement considered all unanticipated device- or procedure-related adverse effects. |
| Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers | Baseline through 12 weeks post second treatment. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fat Layer in the Treated Jawline Area | Baseline and 12 weeks post-final treatment. | 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. |
| Overall Satisfaction With the Treatment | 12-week post-final treatment follow-up visit | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | CoolSculpting for Jawline Contouring |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Age, Continuous | 50.9 years STANDARD_DEVIATION 7.6 |
| Race/Ethnicity, Customized Am Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pac Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 13 Participants |
| Region of Enrollment Canada | 15 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 2 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
Number of Before and After Side-by-side Photograph Pairs Correctly Identified by At Least 2 of 3 Blinded, Independent Reviewers
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting for Jawline Contouring | 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 |
Primary
Number of Participants With Unanticipated Adverse Device Effects (UADE)
This outcome measurement considered all unanticipated device- or procedure-related adverse effects.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CoolSculpting for Jawline Contouring | Number of Participants With Unanticipated Adverse Device Effects (UADE) | 0 Participants with UADE reported |
Secondary
Change in Fat Layer in the Treated Jawline Area
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CoolSculpting for Jawline Contouring | Change in Fat Layer in the Treated Jawline Area | -0.14 cm | Standard Deviation 0.12 |
| Submandibular Ultrasound Measurement (LEFT) | Change in Fat Layer in the Treated Jawline Area | -0.10 cm | Standard Deviation 0.11 |
| Submandibular Ultrasound Measurement (RIGHT) | Change in Fat Layer in the Treated Jawline Area | -0.10 cm | Standard Deviation 0.11 |
| Jowl Ultrasound Measurement (LEFT) | Change in Fat Layer in the Treated Jawline Area | -0.08 cm | Standard Deviation 0.07 |
| Jowl Ultrasound Measurement (RIGHT) | Change in Fat Layer in the Treated Jawline Area | -0.03 cm | Standard Deviation 0.05 |
Secondary
Overall Satisfaction With the Treatment
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CoolSculpting for Jawline Contouring | Overall Satisfaction With the Treatment | 9 Participants |