Skin Tightening of the Mandibular and Sub-mandibular Areas
Conditions
Brief summary
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.
Interventions
DEVICE1440 nm wavelength laser with handpiece (Cynosure)
To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas.
Sponsors
Cynosure, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photographic Evaluation | 3 months post last treatment | Photos will be evaluated by the investigator comparing time baseline and 3 month photos using the global aesthetic improvement scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events | up to 3 months post last treatment | Side effects and events will be recorded |
| Photographic Evaluation | 1 week post treatment | Photos will be evaluated by the investigator comparing time baseline and 1 week photos using the global aesthetic improvement scale |
Countries
United States
Outcome results
None listed