Evaluation of the Safety and Precursors of Efficacy

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

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

Study Overview

• Status: Completed
• Conditions: Subcutaneous Fat
• Intervention / Treatment: Device: 1064nm Laser; Device: 940nm Laser

Detailed Description

The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Staten Island, New York, United States, 103206
      • Aesthetic Pavilion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biopsy of Tissue Sample as a Measure of Effectiveness	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	6 months post treatment
Ultrasound Measurement to Evaluate Reduction of Fat	Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine reduction of fat	6 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High Frequency Ultrasound to Measure Skin Elasticity and Thickness	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.	6 months post last treatment

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Study Director: Patric Krantz, Cynosure, Inc.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: March 25, 2014
• First Submitted That Met QC Criteria: March 25, 2014
• First Posted (Estimate): March 28, 2014

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CYN13-NIF-JD-04