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Evaluation of the Safety and Efficacy of a Non-Invasive Disruption of Fat and Skin Tightening Using 1064nm and 940nm Wavelengths

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ClinicalTrials.gov Identifier: NCT02098811
Recruitment Status : Completed
First Posted : March 28, 2014
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Cynosure, Inc.

Brief Summary:
The purpose of this study is to evaluate and compare the safety and efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.

Condition or disease Intervention/treatment Phase
Subcutaneous Fat Device: 1064nm Laser Device: 940nm Laser Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Efficacy of a Non-Invasive Disruption of Fat and Skin Tightening Using 1064nm and 940nm Wavelengths
Study Start Date : June 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: 1064nm laser Treatment Before Abdominoplasty
Patient will be treated with 1064nm Laser prior to abdominoplasty
Device: 1064nm Laser
Patient will be treated with 1064nm Laser prior to abdominoplasty

Experimental: 940nm Laser Treatment Before Abdominoplasty
Patient will be treated with 940nm Laser prior to abdominoplasty
Device: 940nm Laser
Patient will be treated with 940nm Laser prior to abdominoplasty




Primary Outcome Measures :
  1. Biopsy of Tissue Sample as a Measure of Effectiveness [ Time Frame: 6 months post treatment ]
    Biopsy of treated area will be obtained up to 6 months post treatment and will be histologically assessed for changes in adipocytes, collagen and surrounding tissue to determine effectiveness of device

  2. Ultrasound Measurement to Evaluate Reduction of Fat [ Time Frame: 6 months post treatment ]
    Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine reduction of fat


Secondary Outcome Measures :
  1. High Frequency Ultrasound to Measure Skin Elasticity and Thickness [ Time Frame: 6 months post last treatment ]
    High frequency ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to measure changes in skin elasticity and skin thickness.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Non-smoking subjects between ages of 20-55 years of age presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
  • Subjects (Group 2 and 3) who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
  • Understand and accept the obligation associated with the procedure
  • Subjects with Fitzpatrick skin types I to VI.
  • Subjects (Group 2 and 3) who are willing to consent to participate in the study will be asked to undergo treatment, elasticity and ultrasound measurements, as outlined for each group and defined in section 6.0.
  • Subjects must agree to maintain the same diet and exercise regime throughout the study

Exclusion Criteria:

  • Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
  • A history of allergic reactions to medications or anesthesia required for the procedure
  • A history of thrombophlebitis
  • A history of acute infections
  • A history of heart failure
  • Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment
  • Intolerance to anesthesia or medications to be prescribed before or after the procedure.
  • Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
  • Taking medications that are photosensitive
  • A history of keloid formation
  • A study subject must not be pregnant or have been pregnant in the last 3 months
  • The physician has the right to make determination of eligibility as he/she determines based on the standard of care

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098811


Locations
United States, New York
Aesthetic Pavilion
Staten Island, New York, United States, 103206
Sponsors and Collaborators
Cynosure, Inc.
Investigators
Study Director: Patric Krantz Cynosure, Inc.

Responsible Party: Cynosure, Inc.
ClinicalTrials.gov Identifier: NCT02098811     History of Changes
Other Study ID Numbers: CYN13-NIF-JD-04
First Posted: March 28, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015