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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

NCT02098811•Cynosure, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 55 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

Locations (1)

Aesthetic Pavilion

Staten Island, New York, United States

Key Dates

Start Date

June 1, 2013

Primary Completion Date

May 1, 2014

Completion Date

May 1, 2014

Last Updated

October 27, 2020

Enrollment

ACTUAL participants

Conditions

Subcutaneous Fat

Interventions

1064nm Laser

DEVICE

940nm Laser

DEVICE

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat

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Subcutaneous Fat

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COMPLETEDPHASE2

Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

NCT05760248

Subcutaneous Fat Disorder

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COMPLETEDPHASE2

A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of the Safety and Precursors of Efficacy

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of CBL-514 Injection for Reducing Subcutaneous Fat

Safety and Efficacy Study of 10XB-101 in Adults With Bilateral Flank Adiposity

A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat

Combination of Light and Ultrasound to Reduce Abdominal Fat

Diagnostic Ultrasound for Measuring Fat of the Body

Subject Evaluation of a 1064nm Diode Laser/RF