TriActive

TriActive (Cynosure, Inc, Westford, MA, USA) has the capability to treat cellulite and postliposuction fibrosis with a tri-fold treatment approach using diode laser, contact cooling, and massage to work synergistically to restore the body’s normal homeostatic environment. The TriActive laser energy is emitted through six 808-nm diode lasers to target the endothelial cells to enhance arterial, venous, and lymphatic flow and promote neovascularization. The contact cooling system can manually be adjusted from 10°C to 25°C and it aids in decreasing edema by causing an initial vasoconstriction followed by a compensatory vasodilatation allowing for the pooled fluid to remobilize. The rhythmic massage, which can be selected as either single or dual phase, counteracts circulatory stasis, thereby mobilizing fluids by stimulating lymphatic drainage. In addition, the massage stretches the connective tissue, thus smoothing the interface between the dermis and epidermis.

The parameters of the TriActive system can be manipulated to optimize patient results. The depth and intensity of the rhythmic massage can be controlled by the frequency (0.1–5.0 Hz) and duty cycle (20%–80%). The frequency (hertz) measures the number of aspirations per second. At higher frequencies, a superficial mechanical action is achieved, whereas lower repetition rates stimulate deeper tissue. The duty cycle is the percentage of time for which the aspiration is active between one aspiration and the next. For example, a duty cycle of 70% indicates that the aspiration is active 70% of the time between the 2 aspirations. The higher the value, the stronger the action. Thus, by manipulating the duty cycle and frequency, the intensity and depth of the message can be increased or decreased.

For Fitzpatrick skin types I through III, it is recommend to start at 30 W and then adjusting for patient discomfort and erythema. The frequency should initially be set at 3 Hz with a duty cycle of 60%; the former may be increased to 4 or 5 Hz, but the latter needs to be decreased to 50%. The dual mode is advised for the massage setting. When treating darker skin types, Fitzpatrick skin types IV through VI, energy should be adjusted down to an initial fluence of 20 W. The fluence should be adjusted based on patient discomfort and the level of erythema. The previously mentioned repetition rates (hertz) and duty cycles can be used for skin types I to III. No matter what the skin type is, the contact cooling function should be on and set at the coolest level (10°C) and can be adjusted during the treatment.

A seal of the applicator should always be chambered to the skin; when air is heard to be sucked into the chamber, it indicates that the applicator is not positioned properly for ideal vacuum suction on the skin. Five minutes should be spent on each major surface, that is, the posterior thigh, outer thigh and hip, inner thigh, anterior thigh, and buttocks. Each treatment should last approximately 30 minutes, and each zone should be treated with 3 to 5 passes, with the end point being significant erythema and warmth radiating from the treated skin. The TriActive device has also been used before, during, and after other surgical procedures including liposuction and abdominoplasty. Goldman has noted a marked improvement in irregularities when TriActive is performed after liposculpture. This improvement may be because of the redistribution of dystrophic adipose cells.

The experimental studies in Europe regarding the efficacy of TriActive were conducted by Zerbinati, in which 10 patients were enrolled and each was treated with 20-minute sessions 3 times a week. To evaluate the efficacy of the technique, all the patients were requested not to change habits such as diet, physical activity, and lifestyle in general. Clinical observation, circumference of the thighs and hips, plicometry, skin elasticity, and thermography were recorded. All patients noted an increase in skin tone and a reduction in the circumference of the areas treated.

A similar study to those presented earlier to evaluate the efficacy of the TriActive system without the lymphatic drainage protocol confirmed the importance of lymphatic drainage. A total of 13 healthy women aged 19 to 51 years, with a mean age of 36.6 years and a mean body mass index of 22.26 (19.2–29.3; calculated as the weight in kilograms divided by height in meters squared), were included in the study. Mean starting percentage body fat of the subjects was 22.18% (16.46%–31.02%). Subjects underwent biweekly treatments for 6 weeks. Treatments were administered locally only on the hips and thighs. Efficacy was measured via waist, hip, and thigh circumferences; elasticity; and thermography. Analysis of the results included a subjective evaluation of pretreatment and posttreatment photos by 5 blinded evaluators. An overall improvement of 21% was noted among the treated patients. The most notable improvement was in the appearance of cellulite (23%), skin texture (16%), size (15%), and skin tone (14%). The results of thermography evaluated in this study showed neither changes of mean temperature nor variations in uniformity of temperature distribution in the treated areas. The results revealed a trend toward modest improvement, with steady improvements in hip and thigh circumferences. Comparison to pretreatment photos also suggests modest improvements in the appearance of cellulite and overall appearance, with those subjects starting with the least symptoms showing the greatest degree of improvement. Comparing these results to those of the previous studies suggests the importance of considering the entire system and method as a whole concept to be diligently performed for maximizing results.

Gold evaluated TriActive on 10 women with cellulite who were treated with 15 biweekly sessions. Of the 10 subjects, 9 completed the study and the 1-month follow-up period. There were no significant changes in the subject’s weight. An approximate 50% improvement in the visual grading scale was noted in 80% of subjects.

Nootheti and colleagues performed the first comparative study to determine the relative efficacy of treatment of cellulite using 2 novel modalities, TriActive and VelaSmooth (Syneron Medical Ltd, Yokneam Illit, Israel). VelaSmooth is based on a combination of 2 different ranges of electromagnetic energy, which produces heat, infrared (IR) light and RF combined with mechanical manipulation of the skin and it also has been demonstrated to improve the appearance of cellulite (see later discussion). Patients were treated twice a week for 6 weeks, with randomization of TriActive on one side and VelaSmooth on the other side. A total of 12 treatments per leg were performed. Cellulite grading was determined using the 4-stage Nurnberger-Muller scale, and measurements of thigh circumference were taken before treatment and after the final treatment. Visual inspection and photographic grading were quantified and statistically examined.

In comparing efficacy of treatment between VelaSmooth and TriActive, 28% versus 30% improvement was calculated in the upper-thigh circumference measurements, whereas 56% versus 37% improvement was observed in the lower-thigh circumference measurements. These differences in treatment efficacy, based on the thigh circumference measurements, were not found to be significant ( P >.05). Based on before and after blinded photographic evaluation, 25% (19 of 20) of the subjects showed improvement in cellulite appearance for both TriActive and VelaSmooth. Based on random photographic grading from a scale of 1 to 5 (1, no improvement; 5, most improvement), the average percentages of improvement for VelaSmooth and TriActive are 7% and 25%, respectively. This difference was also not found to be significant ( P = .091). Perceived change grade was also calculated based on random side-by-side comparisons of before and after photographs. About 75% (15 of 19) subjects showed improvement in the VelaSmooth-treated leg, whereas 55% (11 of 19) showed improvement in the TriActive-treated leg. The average mean percentage of improvement was roughly the same for both the treatments (22% [VelaSmooth] and 20% [TriActive]) and showed no statistically significant difference ( P >.05).

Bruising was reported in 60% of the subjects. Incidence and intensity of bruising was 30% higher in the VelaSmooth-treated leg than in the TriActive-treated leg. Of the 20 subjects, 7 reported bruising with VelaSmooth, 1 reported bruising with TriActive, and 3 reported bruising with both VelaSmooth and TriActive. Extent of bruising ranged from minor purpura to larger and diffused bruises, which lasted for a week on average with no intervention. This study revealed that both treatments effectively reduced the appearance of cellulite; however, with a P value of .05, no statistically significant difference was observed between TriActive and VelaSmooth in the reduction of cellulite. TriActive provides low-energy diode laser, contact cooling, suction, and massage, whereas VelaSmooth provides a combination of 2 different ranges of electromagnetic energy, IR light and RF, combined with mechanical manipulation of the skin. After a biweekly treatment for 6 weeks, there was no statistical significance between the 2 units in the upper- or lower-thigh circumference measurements, randomized photographic evaluations, or perceived change in before and after photographic evaluations.

VelaSmooth

VelaSmooth is based on a combination of 2 different ranges of electromagnetic energy, which produces heat, IR light and RF, known as ELOS (Syneron Medical Ltd, Yokneam Illit, Israel). VelaSmooth is a device that combines controlled IR light (700–2000 nm, in the most current model) and conducted bipolar RF energies with mechanical manipulation of the skin to improve the appearance of cellulite. In the most current model, the VelaSmooth peak optical energy is 35 W and the peak RF energy is 60 W. Prior models had a peak optical energy of 12.5 to 20 W and a peak RF energy of 20 to 50 W.

By combining RF energy with optical energy, the required amount of optical energy may be reduced. As a result, most skin types can be successfully treated because RF does not target melanin, and therefore, epidermal heating is reduced. Manipulation is provided via vacuum suction and mechanical rollers in a 40 × 40-mm applicator head.

Before initiating treatment, the skin should be cleaned. Conductive lotion is applied to the treatment area, gel should never be used. Once rehydrated, the skin does not need constant reapplication of conductive lotion even if it appears dry, the electrode rollers remain coupled to the skin as long as proper pressure and contact is made by the operator. However, additional lotion should be applied during treatment if it becomes difficult to move the applicator across the treatment area. Proper applicator seal to the skin surface is indicated by the lack of hearing air being sucked into the chamber in addition to a nonflashing light indicator on the applicator. For the effective and safe delivery of RF energy, it is ensured that the RF rollers maintain equal compression and contact with the skin surface.

Each treatment area (ie, posterior thigh, anterior thigh, inner thigh, outer thigh and hip, buttocks) should be treated for 5 minutes with 3 to 6 passes of the VelaSmooth applicator. The targeted end point is significant erythema and warmth (40°C–42°C, which is maintained for 5–10 minutes) in the treatment area. The time for each treatment session is approximately 20 to 30 minutes per side of the body. With the most current model of VelaSmooth, the manufacturer recommends treatments once a week for 4 to 6 weeks; however, most studies have been performed using earlier, less-powerful models and included biweekly treatments for 4 weeks.

All 3 parameters on this device can be independently adjusted to tailor treatment to each patient’s needs. The treatment levels on all 3 components range from 1 to 3. To maximize the effectiveness of the device for the treatment of cellulite, areas should be treated with the highest levels of IR light and RF (as tolerated by the patient), with a vacuum level of 1 to 2. However, the following exceptions apply: (1) all treatments levels should never be simultaneously set at maximum parameters; (2) in skin types IV to VI or tanned skin, the IR light should be set to 1 to 2. If the patient does not experience lasting erythema or excessive heat, the level may be increased to 2 to 3 and the skin response should be reevaluated; and (3) to increase the degree of patient comfort in sensitive areas, such as the inner thighs and abdomen, the vacuum can be adjusted to a level 1 or 2. Adverse events include erythema, pain, edema, bullae formation, scabbing, ecchymoses, postinflammatory hyperpigmentation, and scarring.

A total of 35 female patients with cellulite of the thighs and/or buttocks were treated in a 2-arm, multicenter study by Sadick and Mulholland. The first group (n = 20) received biweekly treatments for 4 weeks, whereas the second group (n = 15) received biweekly treatments for 8 weeks. All patients were treated with maximum tolerance parameters for all energies (RF maximum energy, 20 W and optical maximum energy, 20 W). Two patients developed crusting, which resolved within 3 days. All patients were evaluated on a quartile scale for percentile improvement from baseline to 3 to 4 weeks after the last treatment session. All patients demonstrated some improvement in the appearance of cellulite. However, patients treated with 16 treatments achieved higher levels of physician-graded improvement, corresponding to a 50% to 75% or 75% to 100% improvement.

Alster and Tanzi investigated 20 patients with moderate thigh and buttock cellulite using biweekly VelaSmooth (20 W RF, 20 W IR) treatments for 4 weeks. This study was conducted in a randomized, split-leg manner, with the untreated leg serving as the control. Physician-graded improvement was based on a quartile scale, similar to the study by Sadick and Mulholland. About 10% of patients experienced ecchymoses, and 90% experienced improvement in the appearance of cellulite on the treated leg, with a mean improvement of nearly 50% at 1 month after the last treatment. All but one of these subjects were interested in receiving treatments to the control leg. Of note, at 3 and 6 months after the last treatment, the physician-graded improvement scale decreased to approximately 35% and 25%, respectively.

Sixteen patients were treated with biweekly treatments for thigh cellulite for 4 weeks in a study by Kulick. All patients were treated with maximal machine parameters, using a RF energy of 20 W and an optical energy of 12.5 W. All patients were followed up for 6 months after their last treatment. Transient erythema occurred after treatment in all patients. Bruising occurred in 32.25% of subjects, but resolved within a week. A single patient sustained a second-degree burn. At 3 and 6 months after the last treatment, the mean investigator-graded improvement scores were 62% and 50%, respectively. At both time points, all patients graded their cellulite improvement to be more than 25%.

In a study by Boey, 17 women received VelaSmooth (using the earlier low-energy model) treatments for mild to moderate cellulite on the thighs, buttocks, and abdomen. The mean investigator-graded improvement from baseline was 32.9%, whereas the mean subject-graded improvement from baseline was 30.6%. Follow-up times and a description of the treatment regimen were not provided. Bruising was reported in 58.8% of patients, but no crusting was reported. Most patients experienced temporary erythema and edema.

In a study by Sadick and Magro, 20 patients with thigh and buttock cellulite were randomized to receive 12 biweekly VelaSmooth treatments in a split-leg fashion. Of the 16 patients who completed the study, 31.25% experienced bruising at some point during the study. At 4 and 8 weeks after the last treatment, as graded by the investigator’s quartile-based scale, 50% (at both time points) of subjects and by an independent investigator-evaluated quartile-based scale, 50% and 68.75% (respectively) of subjects had more than 25% improvement in the appearance of cellulite in the treated leg. At 8 weeks’ follow-up, 31.25% of patients had more than 51% improvement in the appearance of cellulite in the treated leg as graded by the independent investigator.

Similar, split-anatomic controlled studies with the 20 W RF and 20 W IR VelaSmooth have continued to show improvement in the appearance of cellulite as rated by investigator and subject-based grading scales. Many investigators have recommended monthly maintenance treatments to help sustain the clinical improvements.

VelaShape

VelaShape (Syneron Medical Ltd, Yokneam Illit, Israel) is an FDA-cleared device for the noninvasive temporary circumferential reduction in thigh size and temporary cellulite reduction, based on the same combination of bipolar RF, IR light (700–2000 nm), vacuum, and mechanical tissue manipulation as the original VelaSmooth device. VelaShape combines the previous VelaSmooth treatment head along with a smaller (30 × 30 mm) treatment head, the VelaContour (Syneron Medical Ltd, Yokneam Illit, Israel).

VelaShape II is a newer version of the original VelaShape, with 20% more power allowing for shorter treatment sessions, as well as an improved interface terminal to optimize treatments and facilitate device maintenance. The applicator heads have different energy and vacuum parameters. On the VelaShape II platform, the VelaContour is able to achieve up to 440 mbar negative pressure, 20 W peak IR energy, and 23 W peak RF energy, whereas VelaSmooth is able to achieve up to 380 mbar negative pressure, 35 W IR energy, and 60 W RF energy. Instructions for the use of VelaShape are similar to those listed in the previous section. Additional instructions for VelaShape are as follows: large areas (such as the waist, hips, and thighs) are treated with the VelaSmooth applicator for most of the treatment session. In curved small areas, such as the lower abdomen and the periumbilical area, and/or over local fatty deposits, the VelaContour applicator is used instead. The VelaContour treatment is identical to that of VelaSmooth; however, a 20% overlap is recommended with VelaContour. With the new higher-energy VelaShape II, treatments are delivered at weekly intervals (VelaShape II User Manual, 2009). Clinical studies with these newer devices are presently underway. In the authors’ office, they have noted a significant improvement over the use of VelaSmooth.

SmoothShapes

SmoothShapes (Eleme Medical, Inc, Merrimack, NH, USA) is an FDA-cleared device for the temporary improvement in the appearance of cellulite that involves the application of dual wavelengths of laser energy (650 and 915 nm) along with vacuum and massage.

Neira and colleagues investigated the effects of low-level laser energy on adipose tissue. This group demonstrated when adipocytes were exposed to a 635-nm wavelength, a transitory pore was produced within the adipocyte membrane, releasing fat into the intracellular space. Pore formation in the adipocyte membrane was repeated in another controlled study. As a result, the 650-nm wavelength was chosen for its action in enhancing adipocyte membrane permeability and fat emulsification. Of note, the 650-nm wavelength is absorbed minimally in the epidermis and dermis, which allows for enhanced penetration to the subcutaneous tissue. The 915-nm wavelength scatters less than the 650-nm wavelength and is preferentially absorbed by the lipids in fat cells. A temperature increase within the adipocytes results in fat liquefaction. Both the wavelengths are reported to stimulate neocollagenesis and improve blood and lymphatic circulation. Tissue manipulation, using vacuum and massage, enhances the transfer of the liquefied fat within the adipocytes into the intracellular spaces along with improving circulation of blood and lymphatic fluid.

The most current SmoothShapes treatment head (also known as the Photomology module) consists of 2 rollers, a vacuum chamber, four 650-nm light-emitting diodes (LEDs) (1 W), and eight 915-nm laser diodes (15 W) in a 90 × 90 mm dimension. Prior models delivered maximum energies of 1 W from the 650-nm LED and 10 W from the 915-nm diodes. Subcutaneous tissue up to 10 mm depth is heated via the dual laser energy with surface temperatures remaining less than 40°C.

Ecchymoses, erythema, edema, pain, burn, abrasions, scaling, infection, dyspigmentation, and scarring are potential adverse effects from SmoothShapes.

The suction level is recommended not to exceed 500 mbar (375 mm Hg). When initiating treatment, the treatment head is placed on the skin surface and then moved across the treatment area. Each treatment area (eg, posterior, lateral, and anterior thighs) is approximately 8.5 × 11 in. The duration of each treatment area can be selected with a maximum treatment time of 30 minutes, with a default time of 10 minutes (SmoothShapes XV User Manual, 2010).

To date, most SmoothShapes clinical trials have investigated the volumetric effects of SmoothShapes in patients with cellulite, as graded by circumferential reduction and magnetic resonance imaging (MRI), but not the improvement in the appearance of cellulite itself. In the study by Lach, 88.9% of subjects who completed the study reported they were “somewhat” or “definitely” pleased with the results of their treatment. In an abstract presented by Fournier and colleagues, 8 to 12 biweekly treatments were performed using the 915-nm (10 W) and 650-nm (1 W) SmoothShapes device to evaluate the effects on cellulite. Thirty female patients, with Fitzpatrick skin types I to V and with mild to moderate cellulite of the thighs were enrolled in this split-leg study, using the untreated leg as the control. The group reported that a high level of patient satisfaction was achieved.

SmoothShapes was performed on 20 women, with skin types II to VI and with mild to moderate lateral thigh cellulite in a study by Kulick. Patients received biweekly treatments for 4 weeks, with the application of Photomology treatment head for 15 minutes per lateral thigh. Energy was delivered at the maximum settings (1 W for 650 nm, 10 W for 915 nm). Photographic evaluations were performed with standard digital photography and 3-dimensional digital photography at baseline and 1, 3, and 6 months after the final treatment. Textural images for all patients were developed from the 3-dimensional digital photography computer database.

Improved resolution of textural changes was reported with the 3-dimensional digital photography system. Physician-rated improvement was seen in 82% of subjects at 1 month and in 76% at both 3 and 6 months posttreatment. Seventeen patients completed the study, and no adverse events were reported. Textural images showed elevations of depressed areas and reduction of surface bulges. Computer-generated volumetric analysis demonstrated a decrease in thigh volume. At 6 months after the final treatment, 94% of subjects reported sustained improvement in the appearance of cellulite. Percentile improvements based on quartile scales or a similar grading system were not evaluated. Further studies evaluating the clinical appearance of cellulite are necessitated.

Accent

The Accent XL (Alma Lasers Ltd, Caesarea, Israel) platform consists of 2 treatment heads, one using unipolar RF and the other bipolar RF, which is FDA-cleared for the treatment of wrinkles and rhytides. As compared with bipolar RF, unipolar RF is able to affect deeper structures (up to 15–20 mm). The Accent XL UniPolar treatment head emits electromagnetic radiation, and heat is generated through high-frequency (40.68 MHz) oscillations within water molecules. Heat is then subsequently transferred into neighboring tissues. Because of the increased depth of penetration, the unipolar treatment head has been investigated for the improvement of the appearance of cellulite.

Because of the lack of melanin absorption by RF energy, all skin types can be successfully treated. The Accent XL UniPolar treatment head has an integrated cooled treatment tip to increase patient comfort. The unipolar RF energy is delivered up to 200 W. Before initiation of treatment, mineral oil is applied to the treatment area. The operator moves the handpiece across the treatment (6 × 10 in gridded) area in 30-second passes in a circular fashion. Consecutive passes are applied to the gridded area until the treatment end point (40°C–43°C, measured via IR thermometer) is achieved.

Treatment sessions are performed every other week for up to 3 to 4 months. Transient erythema is common and expected. Crusting, blistering, scarring, dyspigmentation, pain, and ecchymoses are potential adverse events associated with unipolar RF treatment.

Alexiades-Armenakas and colleagues assessed 10 female patients with cellulite distributed over the thighs using a novel cellulite grading scale (0–4), which reflected the appearance of contours and dimple depth, density, and distribution. In a randomized split-leg manner, all patients received a mean of 4.22 (range, 3–6) treatments (administered every other week) to the investigational limb, with the untreated leg serving as a control. Unipolar RF energy was emitted at 150 to 200 W per 30-second pass. Photographs were assessed by 2 blinded physicians at each treatment and at 1 and 3 months after the last treatment. At 3 months after the final treatment, dimple density, distribution, and depth improved by 11.25%, 10.75%, and 1.75% to 2.5%, respectively. Overall, an average 7.83% improvement in the appearance of cellulite was reported on the treated leg; however, statistical significance was not obtained. Although most patients demonstrated transient erythema, there were no episodes of scarring, crusting, or dyspigmentation.

A total of 30 patients with moderate to severe thigh cellulite were treated every other week for 3 months with 150 to 170 W of unipolar RF. All areas were treated with 3 passes and 30 seconds per pass. Patients were evaluated 6 months after the final treatment via photography, MRI, estimation of plasma lipid concentrations, and skin biopsy. No changes in plasma lipid levels or blistering, dyspigmentation, or scarring were observed. MRI evaluations at the conclusion of the study failed to reveal a change in the subcutaneous tissue. Fibroplasia of the dermis was noted on histologic examination at 6 months after the final treatment. No changes were present in the subcutaneous tissue on histology. Using standardized digital photography, performed at baseline and 6 months after the final treatment, the mean cellulite improvement was 2.9 (as graded on a 4-point scale). It was concluded that the longevity of results in this study was because of the induction of dermal fibroplasias. Although studies have revealed a good safety profile with unipolar RF, there is a general lack of consensus regarding the efficacy in the improvement of the clinical appearance of cellulite.

Exilis

Exilis (BTL Industries, Inc, Prague, Czech Republic), a device that combines monopolar RF and ultrasonic energy, has recently been introduced to the market with an FDA clearance for the noninvasive treatment of wrinkles and rhytides. Animal studies in porcine tissue have demonstrated that a penetration depth of 30 mm is safely obtainable. The Exilis body treatment head has a cooling tip, an integrated IR thermometer for constant temperature monitoring of the skin surface, and an adjustable RF (watt) energy control. Peak monopolar RF energy and ultrasonic energy are 120 W and 3 W/cm ² , respectively. The integrated Energy Flow Control system eliminates peaks of RF energy. A unique feature of this device, as compared with other RF devices, is the sensor monitors for constant contact between the skin surface and applicator. If the treatment head is removed from the skin surface during treatment, arcing, pain, blistering, or a burn will not result.

Anecdotally, this device has been used off-label for improvement in the appearance of cellulite; however, randomized clinical trials are lacking. For the treatment of cellulite, the treatment area is divided into 20 × 10-cm sections. The grounding electrode is placed adjacent to the zone of treatment, and mineral oil is applied to the skin surface within the gridded area. The cooling tip is adjusted to 10°C, and the treatment head is moved continuously in a circular array within the 200-cm ² grid. The recommended starting RF energy is 50 W and it should be increased over 1 minute until a surface temperature of 40°C to 41°C is reached. Once the target temperature is attained, treatment is continued for an additional 3 minutes to maintain the skin surface at 40°C to 41°C while the RF energy is simultaneously decreased. The average treatment time per grid is 6 minutes, with a total treatment time of 30 minutes per session. Treatments are administered weekly for 3 to 4 weeks. For the following 48 hours after treatment, patients are encouraged to increase their fluid intake, which enhances treatment efficacy by allowing degraded adipose tissue by-products to be eliminated (Exilis User Manual, 2009). Further studies are necessitated to investigate the effects of Exilis on the appearance of cellulite.

TriPollar

TriPollar (Pollogen, Tel Aviv, Israel) combined 3 RF electrodes to deliver low-level (5–30 W) RF energy into the dermis and subcutaneous tissues at a depth of up to 20 mm to produce volumetric heating for immediate collagen contraction and neocollagenesis. The depth of heating is roughly equivalent to the mean difference between the spacing of the RF electrodes. The polarity of the 3 electrodes is in constant alternating rotation between all electrodes (ie, all electrodes have the capability to act as positive or negative, although 1 is always positive and 2 are negative) to avoid overheating of the positive electrode. Cutaneous cooling is not required with this device. As of October, 2010, this product has not received FDA clearance yet.

Before treatment, the skin surface is cleansed and dried. Glycerin oil is applied to the treatment area and then the applicator head is glided across the skin surface in either circular or linear strokes. Erythema and warmth during treatment are expected. Skin temperature should be monitored with an IR thermometer to prevent surface temperatures increasing above 40°C to 42°C, and once the target temperature is obtained, treatment is continued for an additional 2 minutes. Treatments are administered weekly for 6 to 8 weeks, and monthly maintenance treatments are encouraged. Adverse events include erythema (although expected and transient), burns, bruising, and mild discomfort during treatment.

The only cellulite study was performed by Manuskiatti and colleagues on 39 patients with mild to severe cellulite involving the arms, abdomen, buttocks, or thighs. Treatments were administered weekly for 8 treatments using 20.0 to 28.5 W total per treatment. Thirty-seven patients (81 anatomic sites) completed the study. One month after the final treatment session, nearly a 50% mean improvement in the clinical appearance of cellulite, as graded by a blinded investigator, was observed.

Laser-Assisted Lipolysis for the Treatment of Cellulite

Laser-assisted lipolysis (LAL) is indicated for body contouring. Although some physicians use LAL exclusively without liposuction, others think it is best served as an adjunct to liposuction. With traditional liposuction, the improvement in appearance of cellulite is modest, and in certain instances, it may exacerbate cellulite. Because of the simultaneous capabilities of LAL to emulsify fat and stimulate neocollagenesis, resulting in skin shrinkage and tightening, it was extrapolated that this technology may have a role in the treatment of cellulite.

Goldman and colleagues investigated a combination approach of laser lipolysis using a pulsed 1064-nm Nd:YAG laser (SmartLipo, Deka, Calenzo, Italy) and autologous fat transplant in 52 women with moderate to severe cellulite of the hips, buttocks, thighs, flanks, and/or abdomen. Fat was manually harvested via syringe aspiration from a site distant to the areas treated with LAL. An average volume of 240 cm ³ of centrifuged adipose tissue was then transferred to the depressed areas with a 10% to 15% overcorrection. Ecchymoses and edema were common, but no burns or infections occurred. At 1 year posttreatment, patient evaluation of improvement was greater than 75% in 30.8% of patients and 51% to 75% in 53.8% of patients. Although patient satisfaction was high, the isolated effect of the laser was unknown.

In a small study by Palm and Goldman, 9 patients (11 sites) received treatment with either LAL (CoolLipo, CoolTouch Inc, Roseville, CA, USA) or mechanical disruption with a liposuction microcannula. At the conclusion of the study, there was no difference in the efficacy between the 2 treatment regimens, with both groups improving by 1 point on a 4-point investigator-evaluated scale. Patient-evaluated improvement did not differ between the 2 regimens. Further larger studies are needed to investigate the effects of LAL alone in the management of cellulite.