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Single Treatment of Grades II and III Cellulite Using a Minimally Invasive 1,440-nm Pulsed Nd:YAG Laser and Side-Firing Fiber: An Institutional Review Board-Approved Study with a 24-Month Follow-Up Period

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Abstract

Background

Cellulite represents one of the common topographic alterations to the skin surface and one of the structural changes to the subdermal fat and septal band of the posterolateral thighs. Currently, no treatment exists to address this entity with a multifactorial genesis that produces long-term beneficial outcomes. This clinical study evaluated the safety and efficacy of the 1,440-nm laser and the duration of the clinical benefits during 2 years.

Methods

Initially, 25 healthy women with thigh cellulite were enrolled in this prospective institutional review board (IRB)-approved study. For grade II cellulite, the laser fiber delivered up to 1,000 J of energy to the undersurface of the entire involved skin. For grade III cellulite, the laser fiber distributed 1,300 to 1,500 J of energy to melt the subdermal fat, subcise the taut septal bands, and heat the reticular dermis. Baseline and posttreatment analyses included standardized high-resolution photography, skin elasticity measurements, ultrasound scanning for dermal thickness, histology, investigator global assessment scores, and recording of adverse events.

Results

Of the 24 subjects who underwent treatment, only 20 were available for the 6-month follow-up assessment. Objective measurements at 2 years demonstrated an increase over the baseline mean skin elasticity (34 %) and mean dermal thickness (11 %), as well as an increase in the average percentage of dermal thickening determined by ultrasound imaging. Independent investigator global assessments were rated higher for grade II subjects than for grade III subjects throughout the 2-year follow-up period. Mild adverse events disappeared by the third month.

Conclusions

This IRB-conducted clinical trial, as part of a multicenter study for Food and Drug Administration approval, demonstrated the safety and efficacy of a single minimally invasive treatment for grades II and III thigh cellulite during a 2-year follow-up period.

Level of Evidence II

This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

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Disclosure

The author is a consultant for Cynosure, the manufacturer of the device discussed in this study, and declared no conflicts of interest with respect to the authorship and publication of this article. The author received an unrestricted study grant from Cynosure to support this clinical research as part of an IRB-approved and sponsored clinical study.

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  1. Loma Linda University School of Medicine, Loma Linda, CA, USA

    Gordon H. Sasaki

  2. Private Practice, 800 South Fairmount Avenue, Suite 319, Pasadena, CA, 91105, USA

    Gordon H. Sasaki

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Correspondence to Gordon H. Sasaki.

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Sasaki, G.H. Single Treatment of Grades II and III Cellulite Using a Minimally Invasive 1,440-nm Pulsed Nd:YAG Laser and Side-Firing Fiber: An Institutional Review Board-Approved Study with a 24-Month Follow-Up Period. Aesth Plast Surg 37, 1073–1089 (2013). https://doi.org/10.1007/s00266-013-0219-9

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