Evaluation of the Safety and Precursors of Efficacy
Completed · Not applicable
Conditions studied: Subcutaneous Fat
In brief
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.
Key facts
- Study ID
- NCT02098811
- Run by
- Cynosure, Inc.
- People needed
- 10
- Starts
- 2013-06-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2020-10-27
Who can join
Age: 20 and older, up to 55. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Aesthetic Pavilion — Staten Island, New York, United States
Full record on ClinicalTrials.gov
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