Clinical Investigation of Non Invasive Fat Reduction

Subcutaneous Fat Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01842802
• Other study ID #: CYN12-NIF-ABDM02
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: August 2013

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 compare non invasive treatments using a YAG and Didode Laser to reduce the volume of fat.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• A healthy non-smoking male or female between 20-60 years of age

• Subjects 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 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 III.

• Subjects who are willing to consent to participate in the study will be asked to undergo biopsies, ultrasound measurements, and blood testing 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 including EMLA cream or percocet

• 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 deems clinically significant based on standard of care treatment

Related Conditions & MeSH terms

• Subcutaneous Fat

Intervention

Device:
• Diode Laser
Diode Laser for treatment of subcutaneous fat
• YAG laser
YAG laser for treatment of subcutaneous fat

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 Samples as a Measure of Effectiveness	Biopsy of treated area will be obtained up to 5 months post treatment and will be histologically assessed for changes in adipocytes and surrounding tissue to determine effectiveness of device.	5 months post treatment
Primary	Ultrasound Measurement to Evaluate Reduction of Fat	Ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to determine reduction of the subcutaneous fat layer.	5 months post treatment
Secondary	Lipid level blood testing to evaluate changes post treatment	Blood testing will be performed to evaluate changes in lipid levels post treatment	5 months post treatment