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

NCT ID: NCT01813747

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-08-31

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.

Detailed Description

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Conditions

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Skin Tightening of the Mandibular and Sub-mandibular Areas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

1440 nm wavelength laser with handpiece (Cynosure)

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cynosure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patricia Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

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Cosmetique - Dermatology, Laser & Plastic Surgery LLP

Greenvale, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CYN10-DS-MS2

Identifier Type: -

Identifier Source: org_study_id