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

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.

Study Overview

• Status: Completed
• Conditions: Skin Tightening of the Mandibular and Sub-mandibular Areas
• Intervention / Treatment: Device: 1440 nm wavelength laser with handpiece (Cynosure)

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Greenvale, New York, United States, 11548
      • Cosmetique - Dermatology, Laser & Plastic Surgery LLP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1440 nm wavelength laser with hand piece; 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); To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: March 12, 2013
• First Submitted That Met QC Criteria: March 15, 2013
• First Posted (Estimate): March 19, 2013

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CYN10-DS-MS2