Mandible and Sub-mandible Using the 1440nm Wavelength Laser and Hand Piece

Study Overview
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Brief Summary
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The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to provide clinical outcome data for treatment of the mandibular and submandibular areas specifically for skin tightening and laser lipolysis.

Conditions
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Skin Tightening of the Mandibular and Sub-mandibular Areas

Intervention / Treatment
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* Device: 1440 nm wavelength laser with handpiece (Cynosure)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy non-smoking male or female subjects 18-65 years of age Presents for treatment of their unwanted skin laxity and fat in the mandibular and submandibular areas for an improved aesthetic appearance and is willing to undergo laser treatment Understands/accepts obligation not to receive any other procedures in the mid-face to sub-mandibular areas through 3 months follow up visit Understands/accepts the obligation and is logistically able to present for all scheduled follow up visits Is capable of understanding the consent form and able to provide written consent to participate in the study and any other practice consents for anesthesia and surgical procedures Understands/accepts obligation to have facial photographs taken Understands/accepts may be asked to consent to having a two 2mm biopsies in an inconspicuous place such as behind the ear Agrees to maintain present diet and exercise program Exclusion Criteria: Has had any procedure in the mid-face to sub-mandibular areas in the last six months Has a history of thrombophlebitis, history of coagulation disorders or using anticoagulant medications Has a significant systemic illness or immunity disorder or localized condition affecting treatment area Is female and pregnant, was pregnant or given birth within the last three months, is currently breast feeding, or planning a pregnancy during the course of the study Has known history of allergic reactions to local anesthesia Has any other medical condition, that, in the investigator's opinion would interfere with the subject's participation in the study Is susceptible to light induced seizures or history of seizures Has a history of keloid formation Has therapies or medications which may interfere with the treatment (including medications causing photosensitivity Has a BMI above 30

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Even though this study has recruited slightly more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1440 nm wavelength laser with hand piece<br>To assess the effectiveness of the 1440 nm wavelength laser with handpiece for skin tightening and laser lipolysis for the mandibular and sub-mandibular areas | Device: 1440 nm wavelength laser with handpiece (Cynosure)<br>* To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photographic Evaluation | Photos will be evaluated by the investigator comparing time baseline and 3 month photos using the global aesthetic improvement scale | 3 months post last treatment | 
| Photographic Evaluation | Photographs will be evaluated and compared by investigator for baseline and 3 month images using the Cervicomental Angle Scale | 3 months post last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | Side effects and events will be recorded | up to 3 months post last treatment | 
| Photographic Evaluation | Photos will be evaluated by the investigator comparing time baseline and 1 week photos using the global aesthetic improvement scale | 1 week post treatment | 
| Photographic Evaluation | Photographs will be evaluated and compared by investigator for baseline and 1 week images using the Cervicomental Angle Scale | 1 week post treatment |