TriActive Laser (Cynosure, Chelmsford, MA)

The second major FDA-approved laser technology for reducing cellulite is the TriActive laser (Cynosure, Chelmsford, MA), which combines six near-infrared diode laser energy (808 nm) and mechanical massage with superficial cooling. The FDA approved this device in 2003, stating its intended use is “indicated for minor muscle aches, pain, and spasm, and for improvement in local circulation and reduction in the appearance of cellulite”. This system has been shown to produce positive clinical effects on cellulite after a total of 12-16 bi-weekly treatments. The recommended protocol is composed of treatments three times a

Before After

Figure 16.10 Before and after photos of a patient who underwent treatment for cellulite with the VelaSmooth™ System. Photo courtesy of Dr. Boey, Syneron Medical Ltd.

week for two weeks, followed by five weeks of biweekly treatment [14]. This technology was designed with the intention of tightening the skin by increasing lymphatic drainage, increasing superficial blood flow, and stimulating underlying muscles and fascia. With the addition of a laser, TriActive stimulates microcirculation, whereas localized cooling reduces fluid retention (Table 16.4).

TriActive does not have to be administered by a physician because it is a Class I device. Massage therapists are often trained and hired to perform the treatment. The price for treat­ment is $2000-2500 for a series of 16 treatments. TriActive has been found to improve the results of liposuction and is often used in concordance with this procedure.

The TriActive handpiece is equipped with six 808 nm diode lasers, a cooling face, and a suction port. The suction port for mechanical massage is controlled by the frequency (Hz), which measures the number of aspirations per second, and the duty cycle, which can be manipulated to increase or decrease the intensity of the massage. The function of the cool­ing face and the diode lasers are outlined in the preceeding paragraphs [27] (Fig. 16.11).

Since TriActive is a fairly new technology, there is little evidence supporting its efficacy, and clinical trials are ongoing. However, in a study by Frew and Katz, 10 female patients with cellulite, ages 18-60 years, were treated with TriActive bi-weekly for a total of sixteen treatments. Half of the affected body areas were treated with TriActive (diode laser, contact cooling, and suction) and the contralateral sides were treated with contact cooling and suc­tion only. Digital photographs reviewed by blinded physicians and patient surveys revealed that 90% of patients reported improvement, and 80% were satisfied and would continue treatment. The only reported side effects to treatment were minimal bruising, which resolved after a week or two [28]. Similarly, Pabby and Goldman administered 10 Tri­Active treatments over a 5-week period to 11 cellulitic female patients. Blinded evaluation of pre – and posttreatment photos and thigh circumference measurements revealed that all subjects exhibited observable improvement in cellulite and average thigh circumference reduction was 0.83 cm [27]. Like the VelaSmooth system, the long-term efficacy of the TriActive laser is still under review. However, without maintenance, results will diminish within 6-8 weeks (Fig. 16.12).

The VelaSmooth system and the TriActive are the most efficacious treatments for cellu­lite reduction. Not only are these two treatments relatively new, but, unlike other forms of treatment for cellulite, they both have minimal side effects. In a study by Nootheti, et al.,

Table 16.4 VelaSmooth™ versus TriActive Laser Systems[4]

Figure 16.11 The TriActive™ handpiece is equipped with six 808 nm diode lasers, a cooling face, and a suction port. Photo courtesy of Cynosure, Inc.

the efficacy of VelaSmooth and TriActive were tested against one another. In a randomized controlled trial, twenty female patients were treated twice a week for six weeks with VelaS­mooth on one side of their body and TriActive on the contralateral side. Patient evaluation consisted of blinded review of photographs and circumferential thigh measurements before and after treatment. The circumferential upper thigh results revealed a 28% versus a 30% improvement rate in VelaSmooth verus TriActive, respectively. These differences in treat­ment efficacy were not significant (p>0.05). Blinded review of photographs found that 25% of subjects showed an improvement in cellulite appearance and 55-75% of subjects showed a change in cellulite grade. Again, there was no significant difference in the photo results of the VelaSmooth versus TriActive. While no significant difference was found in the effi­cacy of these two laser systems, there was a difference in the side effects of the treatments. The bruising incidence and intensity was 30% higher in legs treated with VelaSmooth com­pared to TriActive. While 7 out of 20 subjects reported bruising in the VelaSmooth leg, only 1 subject reported bruising in the Triactive leg [29].

In conclusion, the safety and efficacy of these methods for reducing cellulite must con­tinue to be evaluated. The efficacy of all of these systems has not yet been perfected, and safety is still a concern. The objective and subjective ways in which clinical trials are evalu­ating the efficacy of different treatments must be monitored for bias. Future combinations of light energies, radiofrequencies, topical treatments, subcutaneous injections, and/or mechanical massage may provide the foolproof answer for improving cellulite appearance (Table 16.5). The long-term efficacy of all of these treatments is promising with mainte­nance, but without maintenance, positive results have been shown to dissipate over time. Cellulite has been an aesthetic issue that women have been trying to combat with different

Figure 16.12 Before and after photos of a patient who underwent treatment for cellulite with the TriActive™ System. Photo courtesy: Cynosure, Inc.

Table 16.5 Body Shaping Technologies of the Future That Can Offer Other Alternatives for Cellulite Reduction

Manufacturer

Device

Energy Source

Mechanism of Action

Regulatory Status (Europe and USA)

Alma Lasers

Accent XL

Unipolar

Heat generated by

CE cleared.

Inc

and Bi-polar Radiofrequency

tissue resistance to radiofrequency – induced current.

FDA 510k

Syneron

VelaSmooth

Vacuum coupled

Tissue manipulation,

CE cleared

Medical Ltd

Bi-polar Radiofrequency, Infared Light

heat generated by tissue resistance to radiofrequency – induced current, infrared – induced heat for skin tightening

FDA cleared

Cynosure, Inc

TriActive

Laser plus vacuum massage

Cellular stimulation plus vacuum massage

FDA 510k

DEKA/

SmartLipo

1064 nm

Laser assisted

CE cleared.

Cyanosure

Nd:YAG laser

destruction of fat cells, coagulation of small blood vessels, collagen shrinkage

FDA cleared

DermaMed

International,

Inc.

C-Sculpt

LED, cooling, and massage

Cellular stimulation plus vacuum massage.

General Project

Slim Project

Computerized vacuum assisted massage

Tissue manipulation.

LipoSonix, Inc

LipoSonix System

Ultrasound

Fat cells disrupted by sound waves.

CE pending FDA pending

(Continued)

Table 16.5 Body Shaping Technologies of the Future That Can Offer Other Alternatives for Cellulite Reduction (Continued)

Manufacturer

Device

Energy Source

Mechanism of Action

Regulatory Status (Europe and USA)

Pollogen Ltd.

Regen

Monopolar plus Bi-polar

Heat generated by tissue resistance to radiofrequency – induced current.

CE cleared

SmoothShapes,

SmoothShapes100

650 nm and

Tissue manipulation

CE cleared

Inc.

900 nm Diode Laser

by vacuum massage, laser assisted reduction of fat layer.

FDA cleared

Syneron

VelaShape

Bi-Polar RF,

Increase in localized

CE cleared

Medical Ltd

Infared Light and Mechanical Massage

metabolism adipose tissue

FDA cleared

Thermage Inc.

ThermaCool

Monopolar

Heat generated by

FDA cleared

System with 3.0 cm2

ThermaTip DC

Radiofrequency

tissue resistance to radiofrequency – induced current.

for non-invasive treatment of wrinkles and rhytides; temporary improvement in appearance of cellulite (not for face of shallow tissue areas)

ThermaMedic

ThermaLipo

RF-AMFLI

technology

Heat generatd by tissue resistance to radiofrequency – induced current

Ulthera, Inc.

Ulthera System

Ultrasound

Tissue heated by sound waves, stimulate new tissue production

CE cleared FDA pending.

UltraShape

Ltd.

CONTOUR 1 ver2

Ultrasound

Mechanical and sound wave – induced disruption of fat cells

CE cleared

methods for decades. It will be interesting to follow the future innovations of surgeons and dermatologists in the search for the perfect ‘cure’ to this widespread issue.

Updated: September 25, 2015 — 2:48 pm