Clinical trial NCT01813747: Mandible and Sub-mandible Using the 1440nm Wavelength Laser and Hand Piece
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Tightening of the Mandibular and Sub-mandibular Areas
Lead sponsor: Cynosure, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Photographic Evaluation
timeFrame: 3 months post last treatment
measure: Photographic Evaluation
timeFrame: 3 months post last treatment
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: up to 3 months post last treatment
measure: Photographic Evaluation
timeFrame: 1 week post treatment
measure: Photographic Evaluation
timeFrame: 1 week post treatment
Other outcomes:
Locations:
city: Greenvale
country: United States
facility: Cosmetique - Dermatology, Laser & Plastic Surgery LLP
state: New York
Study officials:
affiliation: Cynosure, Inc.
name: Patricia Krantz
role: STUDY_DIRECTOR
References: