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OpenTrials
Completed

NCT Number: NCT01813747

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cosmetique - Dermatology, Laser & Plastic Surgery LLP

Greenvale, New York, 11548, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

1440 nm wavelength laser with handpiece (Cynosure)

Device

To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas.

Primary outcomes

  1. Photographic Evaluation

    Time frame: 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

  2. Photographic Evaluation

    Time frame: 3 months post last treatment

    Photographs will be evaluated and compared by investigator for baseline and 3 month images using the Cervicomental Angle Scale

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: up to 3 months post last treatment

    Side effects and events will be recorded

  2. Photographic Evaluation

    Time frame: 1 week post treatment

    Photos will be evaluated by the investigator comparing time baseline and 1 week photos using the global aesthetic improvement scale

  3. Photographic Evaluation

    Time frame: 1 week post treatment

    Photographs will be evaluated and compared by investigator for baseline and 1 week images using the Cervicomental Angle Scale

Sponsors and collaborators

Lead sponsor

Cynosure, Inc.

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2013
Registry last updated
Oct 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.