Cellulite an overview of non-invasive therapy with energy-based systems

Transcription

1 DOI: /j x Review 553 Cellulite an overview of non-invasive therapy with energy-based systems 1, 2, 3, 4 Michael H. Gold (1) Gold Skin Care Center, Nashville, TN, USA (2) Tennessee Clinical Research Center, Nashville, TN, USA (3) Vanderbilt University School of Medicine, Vanderbilt University School of Nursing, Nashville, TN, USA (4) Huashan Hospital of Fudan University, Shanghai China; No. 1 Hospital of China Medical University, Shenyang, China JDDG; : Submitted: Accepted: Keywords celulite orange peel endermologie Summary Cellulite is one of the most common skin care concerns seen in modern dermatology. The presence of cellulite in the 21 st century is now considered a major problem whose treatment options are varied and numerous, all with hopes of improving the appearance of cellulite and maintaining its response over a period of time. The purpose of this article is to review cellulite, its predisposing factors, its classification, and some of the more common devices now in use to treat the disorder. Introduction Cellulite is one of the most common skin care concerns seen in modern dermatology. Once thought of as a true sign of beauty and of wealth, the presence of cellulite in the 21 st century is now a major problem whose treatment options are varied and multitude, all with the hopes of improving the appearance of cellulite and maintaining this response over a period of time. The purpose of this article is to review cellulite, its predisposing factors, its classification, and to review some of the more common devices now in use to improve its appearance. Cellulite, known by many names including liposclerosis, gynoid dystrophy, edematofibrosis, and dermopanniculitis, is a very common entity which, by some estimates, affects all races and up to 85 % of women over the age of 20 years [1, 2]. Cellulite is often described best by comparing its appearance to that of the surface of an orange or an orange peel or with a look resembling cottage cheese look. It is most commonly found on the thighs and buttocks of women, but can also be seen in other areas, such as the abdomen, breasts, and arms. Goldman [3] describes cellulite as a normal physiologic state in postadolescent women that serves to ensure adequate caloric availability for pregnancy and lactation by maximizing adipose deposits; adipose tissue is also essential for nutrition, energy, support, protection, and thermal protection. There are several predisposing factors that are well known and described by most who write about cellulite. These include gender, as noted above, in that more women are affected by cellulite; genetic predisposition, as most women with cellulite can trace cellulite to others in their family as well; cellulite is more common in Caucasians than in other races [4]; cellulite is more common in those with an increase in subcutaneous fat [5]; and age, in that most cellulite occurs on post-pubertal women. Cellulite can be classified into four grades, as shown in Table 1 [6]. This classification can be used to determine one s degree of cellulite and to help follow the response to therapy. Treatment Options for Cellulite There are a myriad of treatment options for cellulite that are available, have been available, and will become available during our lifetimes. If you pick up any women s magazine, you can always find advertisements and testimonials about cellulite creams and potions that are going to work miracles on one s cellulite. Even medical devices, some of which have a Food and Drug Administration (FDA) approval for the treatment of cellulite, need to be kept in proper context; that is, they will improve the appearance of cellulite while the therapy is being performed, and for some time afterward; long term clearance has not yet been proved with any of the medical devices currently on the market for the improvement of cellulite. More research into the arena is needed in order to be able to advise patients properly as to what type of maintenance program is needed, as most believe maintenance is crucial to longterm improvement. The treatment for cellulite, as far as devices are concerned, includes both noninvasive and invasive therapies. This paper will review the noninvasive therapies for cellulite which are the most popular approach today, as more and more people are opting for noninvasive means to improve the appearance of a variety of maladies. The most popular cellulite therapy falls into this group. The first true noninvasive device for the treatment of cellulite is known as Endermologie (LPG, France). This treatment dates back into the early 1990s and was The Author Journal compilation Blackwell Verlag GmbH, Berlin JDDG /2012/1008 JDDG (Band 10)

2 554 Review Cellulite therapy update Table 1: Nürnberger-Müller cellulite classification scale. Stage 0 Stage 1 Stage 2 Stage 3 No dimpling when the subject is standing and lying. The pinch test reveals folds and furrows, but there is no mattress-like appearance. No dimpling while the subject is standing or lying, but the pinch test reveals the mattress-like appearance. Dimpling appears spontaneously when standing and not lying down. Dimpling is spontaneously positive standing and lying down. developed utilizing the theory that vascular and lymphatic alterations promote cellulite; thus devices that integrate massage into the treatment can improve cellulite. This theory, which remains unproven some twenty years after it was introduced, is the basis behind the Endermologie device which has been shown in several clinical studies to improve the appearance of cellulite. The skin is pulled into a mechanical massaging device and kneaded between its rollers to promote lymphatic drainage and alter the skin s architectural framework. In the original study, a 1.86 mm decrease in skin thickness was noted after 12 treatments with the Endermologie device [7]. Other studies noted only marginal results with only 2 out of 17 patients seeing improvement in one of the clinical trials [8]. Despite this, Endermologie remains a popular procedure outside of the US, and will continue to be known as the device that set off the cellulite mechanical revolution. Lasers and intense pulsed light (IPL) sources have also been used to treat cellulite, alone or in combination with massage and mechanical suction. Fink et al., in 2006, reported on the use of an IPL device, with and without an over-thecounter retinoid cream in improving the appearance of cellulite. Eight of the 20 patients enrolled in their clinical trial received IPL alone, while 12 patients received IPL plus retinyl cream. Fifteen of the patients completed the trial; the majority of those reporting improvement greater than 50 % were in the combination therapy group. The authors note the effects diminished over time in most. While there was no control group and no blinding, their study still suggests that combination therapy may be important in cellulite [9]. One of the first combination devices featuring suction, massage, and low-level diode laser light sources, as well as contact cooling was the TriActive, manufactured by Deka Lasers, (Florence, Italy) and originally marketed in the United States (US) by Cynosure (Westford MA), although not available in the US at this time. A newer version, known as the TriActive Plus, is available in Europe and perhaps in the US at a later time. Zerbinati performed the original European study with the TriActive [10]. In this clinical trial, 10 patients were treated three times a week with the TriActive device for 20 minutes. All of the patients noted an increase in their skin tone and a reduction in the circumference of the treated areas. Boyce et al. [11] also evaluated patients with the TriActive. Thirteen patients were enrolled into this clinical trial and each patient received biweekly treatments for six weeks. They found an overall improvement of 21 %. The most noticeable improvements were seen in the improvement of cellulite (23 %), skin texture (16 %), size (15 %), and skin tone (14 %). Modest improvement in the appearance of cellulite and overall appearance of the skin was seen most in those with the least symptoms showing the greatest degree of improvement. Gold [12] evaluated 10 women with biweekly sessions for eight weeks. Nine of the patients completed the study treatments and the one-month follow-up visits. An approximate 50 % improvement was noted in the visual grading in 80 % of the subjects. Clinical examples are shown in Figure 1. Nootheti et al. [13] compared the TriActive to one of the other mechanical cellulite devices (VelaSmooth, Syneron-Candela, Yokneam, Israel). Patients were randomized to receive one of the treatments on one leg and the other on the opposite leg. Although there was a trend towards a greater improvement with the TriActive, the results of the study were not statistically significant. Both devices worked in reducing the appearance of cellulite. Bruising was, however, slightly more noticeable on the VelaSmooth side. The second of the suction, mechanical massage, light-based device is the Vela - Smooth and its next generation device, the VelaShape. A VelaShape II is now available, more powerful (20 %) than its predecessors. VelaSmooth and VelaShape use infrared light ( nm), along with radiofrequency (RF) energy, known as ELOS, to produce IR energy with bipolar RF to improve the appearance of cellulite. Several reports have appeared in the literature to support its effectiveness in this regard [14 18]. Sadick et al. [14] reported on the effectiveness of the VelaSmooth in Thirty-five female patients with cellulite of the thighs and/or buttocks were treated in this clinical trial. Twenty patients received biweekly treatments for four weeks, whereas 15 patients received biweekly treatments for eight weeks. All patients noted improvement in the appearance of cellulite; those treated with 16 treatments achieved higher levels of improvement. Alster et al. [15] evaluated 20 patients with moderate thigh and buttock cellulite using biweekly treatments for four weeks. The patients were treated in a randomized fashion with one leg being treated and the other leg serving as ones control. Ninety percent noted improvement in the appearance of their cellulite; adverse events, mainly ecchymosis, were seen in about 10 % of the patients. The mean improvement was 50 % at one month after the treatments. Improvements at 3 and 6 months after the treatments were noted to be 35 % and 25 % respectively. Others confirmed the effectiveness of VelaSmooth. Kulick [16] treated 16 patients with thigh cellulite biweekly for four weeks. At three and six months after the last treatment, improvement scores by the investigator were noted to be 62 % and 50 % respectively. Patient improvement was noted to be more than 25 % at both time frames. Bruising occurred in % of the patients. Boey [17] evaluated 16 women with mild to moderate cellulite on the thighs, buttocks, and abdomen. Investigator improvement was noted to be 32.9 % from baseline; patient improvement was noted at 30.6 % from baseline. Bruising was noted in 58.8 %. Sadick et al. [18] evaluated 20 patients with the VelaSmooth; patients received 12 biweekly treatments. JDDG (Band 10) The Author Journal compilation Blackwell Verlag GmbH, Berlin JDDG /2012/1008

3 Cellulite therapy update Review 555 Figure 1: Female patient with orange peel skin on right buttock before treatment (a) and after one TriActive treatment with noticeable improvement to skin of right buttock (b). Standard digital photography was utilized. Sixteen patients completed this clinical trial; 50 % and % had more than 25 % improvement in the appearance of cellulite in the treated leg. VelaShape combines the VelaSmooth treatment head with a smaller ( mm) treatment head, known as the Vela- Contour. Several clinical studies with the VelaShape have been performed and show its usefulness in the improvement in the appearance of cellulite. Brightman et al. [19] and Winter [20] have performed clinical trials showing the effectiveness of the VelaShape in post-partum women. In their study, Brightman et al. [19] evaluated 19 patients who underwent five weekly treatments of the upper arm areas and 10 patients who had VelaShape treatments of the abdomen and flanks in post-partum women. They found statistically significant changes in arm circumference at the fifth treatment, with a mean loss of cm. At one and three months follow-up, the mean loss was 0.71 and cm respectively. Reduction in abdominal circumference was also statistically significant, with a mean loss of 1.25 cm at the third treatment and at one and three month s follow-ups of 1.43 and 1.82 cm respectively. Winter [20] also looked at body contouring with the VelaShape in postpartum women. In his study, 20 women received five treatments to the abdomen, buttocks, and thighs. He found the overall mean circumference reduction was 5.4 ± 0.7 cm, with a p < Both the physician and the patients noted improvement in skin laxity and tightening of the skin, p < Both of these studies showed the usefulness of the VelaShape in post-partum women. The next of the FD-cleared devices for the treatment of cellulite is known as SmoothShapes, developed by Eleme Medical Inc. (Merrimack, NH) and now owned by Cynosure (Westford, MA). This device utilizes two distinct wavelengths of light, 650 nm and 915 nm, along with a vacuum apparatus and massage mechanism. The mechanism of action for the SmoothShapes device was first studied by Neira et al. [21]; they noted when adipocytes were first exposed to 650 nm light, a transitory pore is produced in the membrane of the adipocyte, which then allows for the release of fat into the intracellular space. The 915 nm wavelength is preferentially absorbed by the lipids in the fat cells and with an increase in temperature, fat liquefaction is known to occur. With the combination of 635 nm and 915 nm, an increase in neocollagenesis and improvement in blood and lymphatic circulation occurs. The combination of the two wavelengths, the vacuum and massage, improves the appearance of cellulite. The combination treatment is known as photomology. Several clinical studies have looked at the SmoothShapes in improving the appearance of cellulite and producing circumferential reduction. Lach [22] noted that 88.9 % were somewhat or definitely improved with their treatments with the SmoothShape device, which was confirmed with MRI evaluations. Sixty-five subjects were evaluated in this study. After a mean of 14.3 treatments, MRI evaluations pre- and posttreatments showed a fat thickness decrease by 1.19 cm 2 in the leg treated The Author Journal compilation Blackwell Verlag GmbH, Berlin JDDG /2012/1008 JDDG (Band 10)

4 556 Review Cellulite therapy update Figure 2: Female patient before treatment (a); and after eight treatments with SmoothShapes (b). Standard digital photography was utilized. with the device versus an increase of 3.82 cm 2 in the leg treated with massage alone. Pankratov et al. [23] looked at the SmoothShapes device in the improvement of cellulite and found significant results. Gold et al. [24] also evaluated the SmoothShapes in the improvement in the appearance of cellulite and in the reduction on thigh circumference. Eighty-three patients were enrolled in this multicenter clinical trial. One thigh was treated eight times with the device and the other thigh served as the control in this trial. Reduction in thigh circumference was noted in all the treatment areas as compared to the controls, after dividing the areas into upper, middle, and lower thighs after the fifth treatment, the eighth treatment, and at the one month follow-up time period. The maximum reduction ( 0.82 cm) occurred in the upper thigh at one month. The mean reduction of all areas was 0.64 cm for the treated thighs compared to 0.20 cm for the untreated thighs. This difference was statistically significant, p < Cellulite improvement was also noted in these individuals. A clinical example is shown in Figure 2. Kulick [25] looked at the next generation SmoothShapes II device, a smaller and 50 % more powerful device in the treatment of cellulite and circumferential reduction. In his study, 20 women were treated two times per week for four weeks. Utilizing standard photography and the new VECTRA 3-dimensional photographic system (Canfield Scientific Inc., Fairfield, NJ), he noted that 76 % of the subjects enrolled in the clinical trial had an average of 2.3 mm elevation of cellulite dimples and a 4.9 mm of flattening of cellulite bilges six months after their SmoothShapes II treatments. Other energy-based modalities, some currently on the market for skin tightening indications, have also been shown to be effective for the treatment of cellulite. These RF-alone devices produce unipolar or monopolar RF. The first monopolar system, known commercially as ThermaCool or Thermage (Solta Medical, Hayward, CA), has FDA approval for the treatment of cellulite, although clinical trials with regards to its effectiveness are not apparent in the literature; however, it has been shown effective for skin laxity using the Multiplex Tip [26]. The unipolar device, known as Accent XL (Alma Lasers Ltd., Caesarea, Israel), has also been FDA-approved for the treatment of cellulite. It incorporates RF energy deeper into the skin as compared to bipolar RF systems, up to mm. In the first clinical evaluation of this system, Pino et al. [27] evaluated 26 females who each received two treatments with the Accent system with the unipolar hand piece. The authors evaluated the distance from the dermis to the muscle and the dermis to Camper s fascia in the thighs and in the buttocks via ultrasound evaluations. They found that % of the patients had a % decrease in these measurements. They also noted a qualitative improvement of fibrous tissue in 53 % and a straightening of the fibrous bands in 50 %. Alexiades-Armenakas et al. [28] evaluated ten female patients in a randomized, split-leg clinical study. The patients received a mean of 4.22 treatments (every other week). At three months following the final treatment cellulite dimple density, distribution, and depth improved by %, %, and %, respectively. An improvement of 7.83 % improvement in the appearance of cellulite was noted. Goldberg et al. [29] evaluated 30 patients with cellulite utilizing the Accent device and the unipolar hand piece. Each patient underwent six treatment sessions. Twenty-seven patients noted improvement in the appearance of cellulite and circumferential reduction in this clinical study. The mean decrease in leg circumference was 2.45 cm. Histologic changes showed dermal fibrosis in the upper dermis. No MRI or lipid abnormalities were noted. Other RF devices have recently been cleared by the FDA and may have an increasing role in the treatment of cellulite. The Exilis (BTL Industries Inc., Prague, Czech Republic), combines monopolar RF energy and ultrasonic energy. Its FDA clearance is for the treatment of wrinkles and rhytids, although recent antidotal evaluations have shown its effectiveness in the improvement of cellulite. Another device, the TriPollar, or Apollo, by Pollagen (Tel Aviv, Israel) also is being used for the treatment of cellulite. This device uses three RF electrodes to deliver low level RF energy into the dermis and subcutaneous tissues. Several studies in the literature support its use in the treatment of cellulite [30 31]. Manuskiatti et al. [30] evaluated 39 patients with cellulite and patients received 8 weekly treatments with the device. One month after the final treatment, a 50 % mean improvement in the appearance of cellulite was noted. Other devices, such as the Venus Freeze and the Viora Reaction also employ RF and may have a role in the treatment of cellulite; clinical studies with these devices are not available at this time. The Venus Freeze (Venus Concepts, Karmiel, Israel) utilizes multipolar RF and pulsed magnetic fields to accelerate angiogenesis and cutaneous wound healing. In a recent evaluation, Marini [32] was able to demonstrate its effectiveness in skin laxity, body shaping, and cellulite therapy. The Viora Reaction (Viora, Jersey City, NJ) also uses a multimode RF delivery system and clinical trials with this device are pending at the time of this writing. Conclusion The noninvasive treatment of cellulite can be performed with a variety of energy-based devices. One needs to rely on the medical literature to guide us in JDDG (Band 10) The Author Journal compilation Blackwell Verlag GmbH, Berlin JDDG /2012/1008

5 Cellulite therapy update Review 557 the realties form the perceived improvements without science behind them. And one needs to continue to be aware that no long-term clinical studies have ever been carried out with these devices in the treatment of cellulite; therefore, maintenance therapy will be required for continued improvement in most patients treated with these energy-based devices. <<< Conflict of interest Dr. Gold is a speaker for Alma Lasers, Cynosure, Apollo, Venus Concept, Cutera and Syneron. Dr. Gold has performed body contouring research for Alma Lasers and Cynosure. Correspondence to Michael H. Gold, M.D. Gold Skin Care Center 2000 Richard Jones Road, Suite 220 Nashville, TN 37215, USA Tel.: Fax: goldskin@goldskincare.com References 1 Draelos ZD, Marenus KD. Cellulite etiology and purported treatment. Dermatol Surg 1997; 23: Kligman AM. Cellulite: facts and fiction. J Geriat Dermatol 1997; 5: Goldman MP. Cellulite: a review of current treatments. Cosmet Derm 2002; 15: Rossi AB, Vergnanini AL. Cellulite: a review. J Eur Acad Dermatol Venereol 2000; 14: Peterson JD, Goldman MP. Laser, light, and energy devices for cellulite and lipodystrophy. Clin Plastic Surg 2011; 38: Nürnberger F, Müller G. So-called cellulite: an invented disease. J Dermatol Surg Oncol 1978; 4: Marchand JP, Privat Y. A new instrument for the treatment of cellulite. Medicine au Feminin 1991; 39: Collis N, Elliot LA, Sharpe C, Sharpe D. Cellulite treatment: a myth or reality: a prospective randomized, controlled trial of two therapies, endermologie, and aminophylline cream. Plast Reconstr Surg 1999; 104: Fink JS, Mermelstein H, Thomas A, Trow R. Use of intense pulsed light and a retinyl-based cream as a potential treatment for cellulite: a pilot study. J Cosmet Dermatol 2006; 5: Zerbinati N. The TriActive system; a simple and effective way of combating cellulite (internal Deka study). 11 Boyce S, Pabby A, Chuchaltkaren P, Brazzini B, Goldman MP. Clinical evaluation of a device for the treatment of cellulite: TriActive. Am J Cosmet Surg 2005; 22: Gold M. The use of rhythmic suction massage, low level laser irradiation, and superficial cooling to effect changes in adipose tissue/cellulite. Lasers Surg Med 2006; 38(s): Nootheti PK, Magpantay A, Yosowitz G, Calderon S, Goldman MP. A single center, randomized, comparative, prospective clinical study to determine the efficacy of the Velasmooth system versus the Triactive system for the treatment of cellulite. Lasers Surg Med 2006; 38: Sadick N, Mulholland RS. A prospective clinical study to evaluate the efficacy and safety of cellulite treatment using the combination of optical and RF energies for subcutaneous tissue heating. J Cosmet Laser Ther 2004; 6: Alster TS, Tanzi EL. Cellulite treatment using a novel combination radiofrequency, infrared light, and mechanical tissue manipulation device. J Cosmet Laser Ther 2005; 7: Kulick M. Evaluation of the combination of radiofrequency, infrared energy, and mechanical rollers with suction to improve skin surface irregularities (cellulite) in a limited treatment area. J Cosmet Laser Ther 2006; 8: Boey G. Cellulite treatment with a radiofrequency, infrared light, and tissue manipulation device. The American Society of Dermatologic Surgery Annual Meeting. Palm Dessert, CA. October Sadick N, Magro C. A study evaluating the safety and efficacy of the VelaSmooth system in the treatment of cellulite. J Cosmet Laser Ther 2007; 9: Brightman L, Weiss E, Chapas AM, Karen J, Hale E, Bernstein L, Geronemus RG. Improvement in arm and postpartum abdominal and flank subcutaneous fat deposits and skin laxity using a bipolar radiofrequency, infrared, vacuum and mechanical massage device. Lasers Surg Med 2009; 41: Winter ML. Post-pregnancy body contouring using a combined radiofrequency, infrared light and tissue manipulation device. J Cosmet Laser Ther 2009; 11: Neira R, Arroyave J, Ramirez H, Ortiz CL, Solarte E, Sequeda F, Gutierrez MI. Fat liquefaction: effect of low-level laser energy on adipose tissue. Plast Reconstr Surg 2006; 110: Lach E. Reduction of subcutaneous fat and improvement in cellulite appearance by dual-wavelength, low-level laser energy combined with vacuum and massage. J Cosmet Laser Ther 2008; 10: Pankratov MM. Does Body Contouring Need to be Painful? Light Activated Tissue Regeneration and Therapy Conference, Gold MH, Khatri KA, Hails K, Weiss RA, Fournier N. Reduction in thigh circumference and improvement in the appearance of cellulite with dual-wavelength, low-level laser energy and massage. J Cosmet Laser Ther 2011; 13: Kulick MI. Evaluation of a noninvasive, dual-wavelength laser-suction and massage device for the regional treatment of cellulite. Plast Reconstr Surg 2010; 125: Anolik R, Chapas AM, Brightman LA, Geronemus RG. Radiofrequency devices for body shaping: a review and study of 12 patients. Semin Cutan Med Surg 2009; 28: Del Pino ME, Rosado RH, Azuela A, Azuela A, Graciela Guzmán M, Argüelles D, Rodríguez C, Rosado GM. Effect of controlled volumetric tissue heating with radiofrequency on cellulite and the subcutaneous tissue of the buttocks and thighs. J Drugs Dermatol 2006; 5: Alexiades-Armenakas M, Dover JS, Arndt KA. Unipolar radiofrequency treatment to improve the appearance of cellulite. J Cosmet Laser Ther 2008; 10: Goldberg DJ, Fazeli A, Berlin AL. Clinical, laboratory, and MRI analysis The Author Journal compilation Blackwell Verlag GmbH, Berlin JDDG /2012/1008 JDDG (Band 10)

6 558 Review Cellulite therapy update of cellulite treatment with a unipolar radiofrequency device. Dermatol Surg 2008; 34: Manuskiatti W, Wachirakaphan C, Lektrakul N, Varothai S. Circumference reduction and cellulite treatment with a TriPollar radiofrequency device: a pilot study. J Eur Acad Dermatol Venereol 2009; 23: Kaplan H, Gat A. Clinical and histopathological results following TriPollar radiofrequency skin treatments. J Cosmet Laser Ther 2009; 11: Marini L. RF and pulsed magnetic field combination: an innovative approach to effectively addressing skin laxity, body reshaping, and cellulite. Presented at the Indonesian Society for Aesthetic Medicine, Dec 2011, Jakarta, Indonesia. JDDG (Band 10) The Author Journal compilation Blackwell Verlag GmbH, Berlin JDDG /2012/1008