cellulite rx

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Journal of Cosmetic and Laser Therapy. 2005; 7: 81-85 Taylor &i Francis

ORIGINAL ARTICLE

Cellulite treatment using a novel combination radiofrequency, infrared

light, and miechanical tissue manipulation device

TINA S. ALSTER & ELIZABETH L. TANZI

Washington Institute o f Dermatologic Laser Surgery, W ashington, DC, USA

AbstractBackground. Must post-pubenal women exhibit cellulite, particularly in the thigh and buttock regions. The prevalence ofcellulite has led to many attempts at treatment, including a variety of topical solutions, massage-based therapies, andsurgical techniques—most with suboptimal clinical effects. The purpose of this controlled study was toevaluate a novelcombination device involving radiofrequency, infrared light, and mechanical tissue manipulation for the treatment ofcellulite.

Methods. Twenty adult women (ages 25-57 years) ofvarious skin phototypes (I-V), andwith mod erate bilateral thigh andbuttock cellulite, received eight biweekly treatments to a randomly selected side (the eontralateral side serving as a non-treated control). Acombined bipolar radiofrequency., infrared light, and mechanical suction-based massage device wasapplied at 20 watts RF, 20 watts IR (700-1500 nm) light, and 200 millibar vacuum (750 mmHg negative pressure).Patients were evaluated using standardized digital photography and eircumferential legmeasurements at baseline, prior toeach treatment session, and at one, three, and six months after the final treatment. Clinical improvement scores ofcomparable photographs using a quartile grading scale (0^ < 2 5 % , 1 =25%-50%, 2^51%-75%, 3= >75% improvement)were made independently by two masked medical assessors after the series of treatments. Final post-treatment body weight

and patients' subjective evaluations were recorded.Results. Ninety per cent (18/20) of patients noticed overall clinical im provement, and 17 ofthese 18 patients reported thaithey would pursue treatment of the eontralateral thigh. Side effects were limited totransient er>'thema inmost patienls, andbruising was observed in 2/20 patients after the first couple of treatment sessions, but not as the treatmen t series progressed.Clinical improvement scores averaged 1.82 (corresponding to —50% improvement) after the series of treatments.Circumferential thigh measurements were reduced by 0.8 cmon the treatment side.

Cortclmions. Cellulite can be signifieantly and safely reduced with the use ofa noninvasive device that com bines bipolar RF,infrared light, andmechanical massage. The effects of treatment appear tobe prolonged, but maintenance treatments maybe necessary tofurther enhance the clinical results achieved.

Key words: Cellulite, Laser, Light, Massag e, Radiofrequ eney, Treatment

Introduction

Cellulite is a common and perturbing physiologic

condition experienced by most post-pubertal

women. It is clinically manifest by irregular skin

contours or dimpling of the skin, most commonly in

the thigh and buttock regions. It is caused by excess

adipose tissue retention within fibrous septae. The

skin irregularity is proportional to the subcutaneous

fat projected into the upper dermis. The fibrous

septae sequester fat in discrete packets and the

vertically oriented bands are anchored to the deep

fascia, causing the skin surface to pucker.

The etiology of cellulite is unknown, but is

determined by the amount of body fat and the

have more body fat (27%) compared to men (15%)

of proportional body fitness (see (1), p. 1059).

Estrogen increases metabolic rate at one-third the

level of testosterone, causing a significant general-

ized increase in fat deposition in the subcutaneous

tissue of women (see (1), p. 1024). Much gender-

specific fat deposition is based upon hormonal

receptor site density and sensitivity in different body

regions, with insulin exerting an inhibitory effect on

lipolysis and facilitating increased glucose entry into

adipocytes (2,3). Histologic analysis of fibrous

septae in cellulite has shown inflammation (4),

which accounts for localized edema with subsequent

increased projection of adipose tissue. A functional

defect in lymphatic drainage has also been proposed



82 T. S. Alster & E. L. Tami

as has slowed circulation which increases lipogenesis(5). Changes in capillary dynamics cause increasedprotein and fluid extravasation which further slowscirculation and increases acidosis, ultimately leadingto sclerosis, interstitial fibrosis, and decreased

venous retum and lymphatic flow, causing adipocytedeformity and the characteristic skin contour irre-gularities of cellulite (6).

Good diet and physical conditioning do notuniformly prevent the development of cellulite.The prevalence of this cosmetically unappealingcondition has led to many attempts at treatment. Avariety of topical solutions, massage-based therapies,and surgical techniques, including liposuction andsubcision, have been advocated to promote micro-circulation and therefore reduce cellulite — mostwith suboptimal clinical effects (7). More recently,

nonablative lasers and radiofrequency systems havebeen shown to improve skin surface texture due toselective dermal heating which effects neocoUagen-esis (8,9).

The purpose of this controlled study was toevaluate a novel combination device involving radio-frequency, infrared light, and mechanical manipula-tion for the treatment of cellulite.

Materials and methods

Twentv' healthy adult women (ages 25-57 years,mean 48.1 years) of various skin phototypes (I-V)were cleared for study entry. Patient inclusioncriteria were the presence of moderate bilateral thighand buttock cellulite with photographable skincontour irregularities, adherence to a regular dietand exercise program, and lack of weight changefluctuations exceeding 10 pounds in the precedingmonth. Patients were excluded from study entry ifpregnant or lactating, receiving concomitant cellulitetreatments, following fad diets, had a history ofdiabetes or other systemic hormonal irregularities,

had concomitant inflammatory or infectious skinconditions in the treatment areas, or if a history ofdeep venous thrombosis, arterial disease of the legs,or congestive heart failure was present.

Baseline body weight, clinical photographicassessments, and circumferential thigh measure-ments were obtained prior to treatment. All treat-ments were delivered to a randomly selected upperanteromedial and posteolateral thigh and buttock(using the contralateral side as a non-treatedcomparative control). Eight 30-minute treatmentsessions using a combination radiofrequency (RF),

infrared (IR) light, and mechanical suction-basedmassage device (VelaSmooth, Syneron Medical,

level of 200 millibar (750 mmHg negative pressure).Four to six (average, five) passes of the device wereapplied to each treatment area.

Side effects of treatment were recorded at everysession. Standardized digital photographs usingconsistent patient positioning, camera angling, light-ing, and backd rop conditions were obtained, as wellas circumferential thigh measurements prior to eachtreatment and at one, three and six monthspost-treatment. Clinical improvement scores ofcomparable photographs using a quartile gradingscale (0 -< 25 % , l=25%-50% , 2 = 51%-75%,

3 = > 7 5 % improvement) were made independentlyby two masked medical assessors after the series oftreatments. All photographs were shown in randomorder: first, to determine whether improvement

could be ascertained, and, secondly, for clinicalgrading. Final post-treatment body weight andpatients' subjective evaluations of treatment wererecorded.

Results

All 20 patients completed the 7-mon th study. All buttwo patients noticed overall improvement in cellulitein the treated thigh/buttock regions based onsubjective questionnaires. Seventeen of these 18patients reported that they would undergo treatment

on the contralateral thigh. The one patient whowould not pursue additional treatment had experi-enced bruising with the initial sessions. Side effectswere limited to transient erythema in most patients(average duration < 1 ho ur). Bruising was observedin 10% (2/20) of study participants after the firstcouple of treatmen t sessions, but in no patient as thetreatment series progressed. Treatment was welltolerated with minimal to no discomfort — thesensation most often described as "mild heating"with occasional "pinching".

Clinical improvement scores averaged 1.82 (cor-responding to approximately 50% improvement)one month after the series of treatments. Slightdiminution of clinical effect was noted at the three-and six-month follow-up evaluations (Figures 1, 2Aand B, 3A and B ). Circumferential thigh measure-ments were reduced by 0.8 cm on the treatmen t side(Figure 4 ). The re were no m easurable differences inthe non-treated thighs nor in total body weight(average baseline weight = 148.3 lbs, post-Rx weight= 148.0 lbs) at end-study.

Discussion



Cellulite treatment 83

1+ R x- Rx

1 month post-Rx 3 month s post-Rx 6 month s post-Rx

Grading: 0 = <25%, 1 =25%-50%.2 = 5P/O -7SV 3 = >75''(, improvement

Figure 1. Clinical improvement scores.

extracts that serve to temporarily dehydrate fat cells,making tbem appear smaller (10-13). The watertbat is drawn into tbe surrounding skin by simplebydra tion may additionally give tbe skin a firmerappearance. Various berbal ingredients (e.g., blackpeppe r, ginger, green tea, capsicum, cinnamon) havebeen popularized due to their ability to stimulatemicrovascular flow (14). Retinol has been shown to

keep fat cells from maturing in laboratory tests (15).Tbe biggest drawback to topical cellulite treatmentsis tbeir inability to significantly penetrate skin inorder to render more than a transient (and super-ficial) tissue effect. Tbe concomitant use of occlusivegarments has been shown to enhance the penetration(and perhaps potentiate the effect) of topical agents,but again, tbe results appear limited and temporary(14).

2 ^ ^



84 T. S. Alster & E. L. Tanzi

I+Rx- Rx

Baseline Post-Rx

Figure 4. Thigh measurements (in centimeters).

Noninvasive massage therapies,, including suction-based mechanical massage units such asEndermologie in which motorized rollers on either

side of a vacuum chamber produce up to 500 mbarof low pressure, have been studied with variableresults (16). Endermologie's efficacy in improvingcellulite is believed to result from stretching of thevertical connective tissue and stimulation of lym-phatic flow as a result of the extreme pressuredifference and the rolling motion dictated by thetechnique. Collis and colleagues studied the effectsof aminophylline cream and Endermologie alone,and in combination, for thigh and buttock cellulite,and determined that no statistical difference existedin leg measurements in any treatment group

(17). Subjective assessments revealed slightly betterresponse to the Endermologie-treated legs than tothe aminophylline-treated legs, but the authorswere unconvinced as to the efficacy of eithertreatment.

Dietary supplements containing cellasene, gingkobiloba, sweet clover, and grape seed have beentouted to increase metabolism and circulation whiledecreasing swelling, but are not FDA-approved ascellulite treatments. In addition, cellasene containssignificant levels of iodine and therefore should beavoided by those individuals with thyroid conditions.

Surgical subcision has been noted to improvemoderate to severe cellulite (18). The techniqueinvolves the insertion of a needle to interrupt theconnective tissue adhesions that tether the dermis tothe underlying fascia, thereby diminishing the lumpyskin appearance. The longevity of clinical effectremains unclear, Liposculpture has also been used todecrease the appearance of celiulite by reducing localfat volume and by disrupting the fibrous bands, butagain, long-term results are lacking.

Mesotherapy is yet another popularized treatmentfor cetlulite, despite few studies substantiating itseffectiveness and longevity (19,20). The techniqueinvolves a series of injections that perfuse a variety of

is responsible for lipolysis. The lack of a precisetreatment protocol and the risk of localized adverseevents, including edem a, ecchymoses, tende r subcuta-

neous nodules, infection, urticaria! reactions, andirregular skin contours, led to banning of phosphati-dylcoholine by the Brazilian National Agency ofHealth in 2003, Its use in the US has yet to beapproved by the FD A.

The study reported herein demonstrates one ofthe latest noninvasive treatments for cellulite andinvolves a combination of mechanical massagewhich improves microcirculation and concomitantradiofrequency and infrared light heat delivery to thedermis which can initiate collagen remodelingthrough controlled tissue inflammation and collagen

contraction. No significant side effects wereobserved and patients tolerated the treatment ses-sions without difficulty. The fact that clinical resultsremained in evidence for several months after theseries of eight sessions attests to the longevity of thetreatment. However, in practice, it would seemreasonable to continue maintenance treatments on amonthly basis in order to further enhance the resultsobtained.

One could argue that any treatment that makesthe skin thicker and more reflective can reduce theappearance of cellulite. The use of topical creamsthat tighten, moisturize, and attempt to thicken theepidermis thus have been shown to improve theclinical appearance of cellulite, albeit temporarily.Combined technologic advances, such as demon-strated by the device in this study, serve to add evenfurther clinical improvement, as well as longevity tothe results obtained. The negative pressure massageserves to improve circulation and loosen the bands ofconnective tissue around the fat deposits that causeskin dimpling, while the radiofrequency and infraredenergy heat the skin, creating a controlled inflam-matory response and rendering it more malleable

and receptive to the rolling action of the massageunit. Lymphatic drainage is thus enhanced creating



Cellulite treatment 85

massage technology has been shown to be a safe andeffective treatment option with long-lasting results.Maintenance treatments may extend and funherimprove upon the results obtained.

Conclusions

Cellulite can be significantly and safely redu ced withtbe use of a noninvasive device tbat combines bipolarRF, infrared light, and mecbanical massage. Theeffects of treatment appear to be prolonged, butmaintenance treatments may be necessary to furtherenhance the clinical results achieved.

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6. Leibaschoff GH. Cellulite (liposclerosis): etiolog\' and treat-ment. Am J Cosmet Surg. 1997;14:39'i-401.

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12. Jackson EM. Substantiating the efficacy of thigh creams.Cosmet Dermatol. 19Q5;8:31-4L

13. Dickinson BI, Gora-Harper ML. Aminophylline for celluliteremoval. Ann Pharmacother. 1996;30:292-3.

14. Rao J, Paabo KE, Goldman MP. A double-blinded rando-mized trial testing the tolerability and efficacy of a noveltopical agent with and without occlusion for the treatment ofcellulite: a study and review of the literature. J DrugsDermatol. 2004;3:417-25.

15. Kligman AM, Pagnoni A, Stoudemayer T. Topical retinolimproves cellulite. J Derm atolT reat. 1999;I0:l 19-25.

16. Chang P, Wiseman J, Jacoby T, Salisbury AV, Ersek RA.Noninvasive mechanical body contouring (Endermologie): aone-year clinical outcome study update. Aesthetic Plast Surg.]998;22:!45-53.

17. Collis N, Elliot LE, Sharpe C, Sharpe DT. Cellulitetreatment: a myth or reality: a prospective randomized,controlled trial of two therapies, Endermologie and amino-phylline cream. Plast Recontr Surg. 1999;104:l 110-17.

18. Hexsel DM, Mazzuco R. Subcision: a treatment for cellulite.Int J Dermatol. 2000;39:539 44.

19. Rotunda AM, Suzuki H, Moy RL, Kolodney MS. Detergenteffects of sodium deoxycholate are a major feature of aninjectable phosphatidyleholine formulation used for localizedfat dissolution. Dermatol Surg. 2004;3a:1001-09.

20 . Hexsel D, Serra M, Mazzueo R, Dal'FornoT, Zechmeister D.Phosphatidyleholine in the treatment of localized fat. J DrugsDermatol. 2003;2:511-18.

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