Clinical and Histological Evaluations of a 1060nm Laser Device for Non-Invasive Fat Reduction

JOHN W. DECORATO, MD, FACS

Study Design:

  • 17 subjects in total were treated; 11 treatments being in the abdomen and 6 in the ank.
  • Pre- and post-treatment, a thermocouple needle was placed into the treatment area to measure tissue temp at interval depths (5, 10, 15, 20, 25, 30mm).
  • 1060nm diode laser with contact cooling for skin protection to cause injury to subcutaneous adipose tissue (SAT) by establishing a controlled hyperthermic temperature of 42-47°C.

    Evaluation:

    • Ultrasound measurements of fat thickness were performed at baseline, 6 and 12 weeks post-treatment.

    • High resolution photographs were taken at baseline and 12 weeks post-treatment.

Results:

• Laser treatments were well-tolerated by all subjects with no damage to the skin.

• Side effects included mild pain, stinging and numbness, all resolved by 2 weeks.

Conclusion:

  • Ultrasound, MRI, and photographic evaluations show similar level of fat reduction by laser hyperthermic treatment as compared to cryolipolysis (24%).
  • The in vivo tissue response demonstrated that a prolonged hyperthermic exposure can cause adipocyte injury.

Fat thickness changes demonstrated by ultrasound

Baseline 3 Month Post Tx 6 Month Post Tx

Total depth of adipose tissue (cm)

Results-MRI Measurements

Average reduction in fat volume as compared to cryolipolysis:

3 MONTH POST TX

6 MONTH POST TX

Fat Volume Reduction

Laser Side

Cryo Side

Laser Side

Cryo Side

Average Reduction

24%

(±9%)

22%

(±13%)

21%

(±10%)

19%

(±9%)

Example of fat thickness changes demonstrated by MRI:

Control Side Laser Tx Control Side Laser Tx

Control Side

Laser Tx

Baseline 3 Month Post Tx

6 Month Post Tx

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© 2015 Cynosure, Inc. Cynosure is a registered trademark of Cynosure, Inc. 921-0571-000 Rev.1 09/15

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