Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area Using Cryolipolysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Body Fat Disorder
- Sponsor
- Zeltiq Aesthetics
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Percentage of Correct Identification of Pre-treatment Photographs
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Study to Evaluate Non-Invasive Subcutaneous Fat Reduction in the Submental Area using Cryolipolysis.
Healthy adult men and women with submental skin fold thickness > 1cm who desire reduction of submental fat.
Detailed Description
Non-invasive treatment for subcutaneous fat reduction in the submental area.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects \> 22 years of age and \< 65 years of age.
- •Submental skin fold thickness \> 1cm (measured by caliper).
- •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
- •Skin laxity in the neck or chin area for which reduction in submental 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 submental fat
- •Evidence of any cause of enlargement in the submental 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 neck or chin area (below the mandible) within the past 6 months.
- •Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within 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 dental infection.
Outcomes
Primary Outcomes
Percentage of Correct Identification of Pre-treatment Photographs
Time Frame: 12 week post-final-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 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. 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.
Safety of CoolScupting in the Submental Area
Time Frame: Time of enrollment through12 week post-final treatment follow-up
Safety of the Zeltiq CoolSculpting device will be assessed by measuring the incidence of device- and/or procedure-related adverse events. Adverse event reports are collected from the time of enrollment through the 12 week follow-up visit.
Secondary Outcomes
- Change in the Fat Layer of the Treated Area as Measured by Ultrasound(12 weeks post-final treatment)
- Subject Satisfaction With CoolScupting in the Submental Area(12 weeks post-final treatment)