1. Endermologie vs Vasershape followed by Endermologie
2. Vasershape vs Vasershape followed by Endermologie
3. Vasershape vs Velashape II
1. Vasersmooth vs Cellulaze
2. Vasersmooth vs Slim Lipo cellulite device
3. Vasersmooth vs Vasersmooth adding autologous stem cells
4. Vasersmooth vs Vasersmooth adding autologous fat transfer
5. Vasersmooth vs Vasersmooth adding stem cells & fat transfer
6. Vasersmooth vs Vasersmooth adding Platelet Rich Plasma (PRP) & fat transfer
Cellulite is present in about 85% of post-pubescent woman, which usually affects the thighs and buttocks.1,2 The pathogenesis of cellulite includes fibrous septae attachments of the skin extending into the subcutaneous fat connecting to the underlying muscle, a thickened hypodermal fat layer, hypodermal fat lobules herniating into the dermal-hypodermal interface and reduced microcirculation.3,4 Ultrasound imaging has been used to view both the skin thickness and the dermis-hypodermis interface.5
There are currently numerous medical technologies, both minimally invasive and non-invasive, marketed for the treatment of cellulite. However, if one current technology is superior to all the others, this study would be unnecessary. This study is designed to compare both minimally invasive and non-surgical technologies.
The first modality for the treatment of cellulite was developed in the 1970’s known as Endermologie (LPG Systems, Valence, France). This is a non-invasive motorized mechanical roller that mobilizes subcutaneous fat, temporarily improves microcirculation up to four fold up to 6 hours post-treatment, increases flow velocities in the subcutaneous veins within the adipose tissue, and improves lymphatic drainage by three fold up to 3 hours post-treatment, however, in vivo redistribution of fat was not demonstrated.6
Additionally, biopsies revealed that Endermologie increases elastin or oxytalan fiber diameter and density, and collagen fibers show a more compact appearance with increased density in the papillary and upper reticular dermis (although the collagen effect is weaker than the elastic fiber effect). Despite these histological changes, there was no change in skin elasticity as measured by a Cutometer. There is no evidence to document if this is a temporary or permanent effect. There was a subjective observed reduction in adipose volume, however, this observation lasted only two weeks after treatment.7 A porcine study revealed accumulation of dense, longitudinal collagen bands in the mid and deep sub-dermis with distortion and disruption of adipocyte cell membranes. No inflammatory response, skin or muscle injury was observed. The skin and subcutaneous tissue thickness remained constant.8
Patient’s lost a mean weight of 1.35 pounds and a mean body circumference of 0.54 inches undergoing 7 sessions.9 Another study confirmed these findings with a mean weight reduction of 0.45 pounds and body circumference of 0.45 inches after undergoing 20 sessions of treatment, although no long term follow-up was performed.10
Additionally, Endermologie demonstrated softening of superficial skin surface irregularities and cellulite with a 50% improvement by objective blind photographic grading and a 92% patient satisfaction rate. However, objective measures of body contouring were minimal and proportional to weight loss. Thus, Endermologie alone should not be considered an effective body contouring method.10 Endermologie is approved by the Food and Drug Administration for the temporary improvement in the appearance of cellulite.
Technology using a mechanical roller, infrared light at 700 nm and bipolar radiofrequency was developed and underwent two alterations, known as Velasmooth, Velashape I and the newest model, Velashape II (Syneron Medical Inc., Irvine, California). Heat generated by the infrared light and radiofrequency is theorized to increase the dissociation of oxygen from oxyhemoglobin and diffusion into adipose tissue. As with Endermologie, the mechanical massage improves circulation and may stretch the connective tissue bands in the fat layer.11 Velashape II is approved by the Food and Drug Administration for the temporary improvement in the appearance of cellulite.
A non-focused ultrasound device, Vasershape, manufactured by General Projects (Florence, Italy) and distributed in the United States by Sound Surgical Technologies (Louisville, Colorado) was FDA approved as a non-invasive device for the temporary treatment of cellulite in 2010. The Vasershape system delivers a non-invasive treatment that uses therapeutic massage and ultrasound diathermy using the combined action of two low-frequency ultrasound heads cross-sectioned onto the area being treated. This advanced ultrasound hand piece is placed over the skin so that the deep penetrating action of the ultrasound, up to 5 cm, is concentrated onto the affected tissue only, offering a treatment has been shown to be both safe and effective.12
The action of the low-frequency ultrasound (ultrasound diathermy) must always be followed with lymphatic drainage. This is performed through the use of the suction/massage hand piece and a special elastomeric membrane, which applies movement to the tissue. This membrane operates in an undulating motion, which gently lifts, folds and compresses the tissue following a sequence of movements specific to each area being treated. This manipulation of the cutaneous and subcutaneous tissues improves lymphatic, arterial and venous circulation. With the same hand piece, the lymph nodes are opened prior to drainage, thus allowing the elimination of potential toxins and lipids in the interstitial spaces caused by the action of the ultrasound.
In the first published series using Vasershape in the US, the multi-center study revealed reductions of 2.1 inches in the abdomen and 1.0 inch in the thighs over 5 treatments performed once per week, and reductions of 0.8 in and 0.5 in, respectively, were achieved after the first treatment. These results were achieved with no adverse events and no patient discomfort.13
Due to the less than optimal outcomes for cellulite treatment using any of the non-invasive medical technologies, minimally invasive techniques used for the treatment of cellulite have been brought to market.
The minimally invasive medical technologies to be investigated in this study are the laser and ultrasound energy based devices. The two laser technologies to be investigated are Cellulaze (Cyanosure, Westford, Massachusetts) side light fiber at 1440 nm and the Slim Lipo Cellulite device (Palomar Medical Technologies, Burlington, Massachusetts) side light fiber at 924 nm. The non-focused minimally invasive ultrasound device at 36 kHz to be studied is known as Vasersmooth (Sound Surgical Technologies, Louisville, Colorado). Variants of the Vasersmooth device technique include the addition of autologous fat grafting, autologous stem cell grafting and a combination of the fat and stem cell grafting methods.
Minimally invasive laser cellulite treatment was recently evaluated for efficacy, safety and duration of clinical benefit in ten patients using Cellulaze (Cyanosure, Westford, Massachusetts), a pulsed laser that delivers energy at 1440 nm using a side firing light fiber.13 The study revealed with a single treatment observed for at least one year produced a “good” rating by survey. The results showed a patient survey of 3.2 and a physician survey of 3.4 (5 point scale) with a patient satisfaction rate of 93%. Objective measures revealed improved skin elasticity of 29%, by elastometry, and increased skin thickness of 25%, by diagnostic ultrasound. The author concluded the following: 1) uneven dermal-hypodermal interface by melting the hypodermal fat to prevent its expansion into the hypodermis, 2) the connective tissue septae were thermally subcized and 3) the dermal layer due to heat production to increase skin thickness, producing skin tightening and stimulate collagen synthesis.13
Palomar Medical Technologies has no published data on their new minimally invasive side firing 924 nm laser cellulite device. Sound Surgical Technologies has no published data on their new minimally invasive Vasersmooth side cutting ultrasound probe device.
The non-invasive technologies to be evaluated in this study include: non-focused ultrasound (1 mega Hz) or Vasershape (Sound Surgical Technologies, Louisville, Colorado), mechanical massage or Endermologie (LPG Systems, Valence, France) and a combination of infrared light (700 nm), mechanical massage and bipolar radiofrequency or Velashape II (Syneron Medical Inc., Irvine, California).
The goal is to determine the efficacy and the side effects observed of each device in a direct comparison. An additional non-invasive investigation will combine two recognized cellulite treatments, non-focused ultrasound (Vasershape) and mechanical massage (Endermologie) to improve the outcome of each used separately. The universal cellulite grading system developed in 1972, the Nurenberger-Muller Grading Scale, was chosen to ensure uniformity in cellulite assessment. There are four grades of cellulite ranging from grade 0-3:
Grade 0: “No cellulite”. There is no visible cellulite while standing. With pinching the skin, there is no appearance of cellulite. This grade of cellulite is rare and very desirable.
Grade 1: “Tight cellulite”. There is no cellulite when standing, however, when one pinches the skin of the thigh/buttock or when the thigh/buttock muscles are contracted, one will see the appearance of orange peel or mattress appearance of the skin. The pinch test should be painless and the skin-fold small.
Grade 2: “Loose cellulite”. There is visible cellulite while standing, but it is not visible when lying. The cellulite is visible when the subject contracts the buttocks or when the skin is pinched. The skin is generally loose and has a painless skin pinch.
Grade 3: There is visible cellulite while standing and in the supine position. Some refer to this as “painful cellulite”, any type of cellulite, which is characterized by significant tenderness during the pinch test.
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2. Rosenbaum M, Prieto V, Hellmer J, et al. An exploratory investigation of the morphology and biochemistry of cellulite. Plast Reconst Surg 1998; 101:1934-1939.
3. Avram MM. Cellulite: areview of its physiology and treatment. J Cosmet Laser Ther 2004;6:181-185.
4. Draelos Z. The disease of cellulite. J Cosmet Dermatol 2005;4:221-222.
5. Querlox B. Cellulite characterization by high-frequency ultrasound and high-resolution magnetic resonance imaging. In: Goldman MP, Bacci PA, Leischof G, Haxel D, Angelini F, editors. Cellulite: Pathophysiology and Treatment, New York, NY: Taylor & Francis;2006:105-114.
6. Watson J, Fodor PB, Cutcliffe B, et al. Physiological effects of Endermologie: A preliminary report. Aesthetic Surg J 1999;19(1):39-45.
7. Revuz J, Adhoute H, Cesarini JP, et al. Clinical and histological effects of the Lift6 device used on facial skin ageing. Les Nouvelles Dermatologiques, 2002;21:335-342
8. Adcock D, Paulsen S, Davis S, et al. Analysis of the cutaneous and systemic effects of Endermologie in the porcine model. Aesthetic Surg J 1998;19:414-420.
9. Ersek RA, Mann GE, Salisbury S, et al. Noninvasive mechanical body contouring: a preliminary clinical outcome study. Aesthetic Plast Surg 1997;21:61-67.
10. La Trenta, G. Endermologie versus liposuction with external ultrasound assist. Aesthetic Surg J 1999;19(6):24-30.
11. Sadick NS, 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 2005;7:81-85.
12. Atluri P, Barone F, Cervone J. Clinical Effects of Noninvasive Ultrasound Therapy for Circumferential Reduction Am Journal Cosmet Surg 2012; 29(2):114-120.
13. DiBernardo BE. Treatment of cellulite using a 1440-nm pulsed laser with one-year follow-up. Aesthetic Surg J 2011;31:328-341.
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