Cryolipolysis for Jawline Contouring
Not Applicable
Active, not recruiting
- Conditions
- Body Fat Disorder
- Interventions
- Device: The ZELTIQ System
- Registration Number
- NCT03352141
- Lead Sponsor
- Zeltiq Aesthetics
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 45
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fat Reduction The ZELTIQ System The treatments are designed to see if the fat can be reduced along the jawline with Cryolipolysis.
- Primary Outcome Measures
Name Time Method Safety endpoint in relation to adverse events Through study completion, an average of 9-months. Measurement of device- or procedure-related adverse events. It is expected there will be zero UADEs
Photo review 12 weeks post second treatment. Correct identification of pre-treatment vs. final post-treatment visit images by two out of three blinded independent reviewers.
- Secondary Outcome Measures
Name Time Method Effectiveness endpoint gauged by reduction in fat layer thickness 12 weeks post second treatment. Reduction in fat layer thickness as measured by ultrasound at the final post-treatment visit.
Trial Locations
- Locations (1)
Pacific Derm
🇨🇦Vancouver, British Columbia, Canada