Evaluation of the Safety and Precursors of Efficacy

Not Applicable

Completed

• Conditions: Subcutaneous Fat
• Interventions: Device: 1064nm Laser; Device: 940nm Laser

• Registration Number: NCT02098811
• Lead Sponsor: Cynosure, Inc.

Brief Summary

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.

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 Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-28
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-23
• Last Update Posted: 2020-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1064nm laser Treatment Before Abdominoplasty	1064nm Laser	Patient will be treated with 1064nm Laser prior to abdominoplasty
940nm Laser Treatment Before Abdominoplasty	940nm Laser	Patient will be treated with 940nm Laser prior to abdominoplasty

Primary Outcome Measures

Name	Time	Method
Ultrasound Measurement to Evaluate Reduction of Fat	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
Biopsy of Tissue Sample as a Measure of Effectiveness	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

Secondary Outcome Measures

Name	Time	Method
High Frequency Ultrasound to Measure Skin Elasticity and Thickness	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.

Trial Locations

Locations (1)

Aesthetic Pavilion; 🇺🇸 Staten Island, New York, United States