Evaluation of the Safety and Precursors of Efficacy

Subcutaneous Fat Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098811
• Other study ID #: CYN13-NIF-JD-04
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: May 2014

Study information

• Verified date: October 2020
• Source: Cynosure, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Subcutaneous Fat

Intervention

Device:
• 1064nm Laser
Patient will be treated with 1064nm Laser prior to abdominoplasty
• 940nm Laser
Patient will be treated with 940nm Laser prior to abdominoplasty

Locations

Country	Name	City	State
United States	Aesthetic Pavilion	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Cynosure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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