Journal of Cosmetic and Laser Therapy, 2011; 13: 13–20 ORIGINAL ARTICLE Reduction in thigh circumference and improvement in the appearance of cellulite with dual-wavelength, low-level laser energy and massage J Cosmet Laser Ther Downloaded from informahealthcare.com by HINARI on 03/30/11 For personal use only. MICHAEL H. GOLD1, KHALIL A. KHATRI2, KELLEY HAILS3, ROBERT A. WEISS4 & NATHALIE FOURNIER5 1Tennessee 3Seacoast Clinical Research Center, Nashville, TN, USA, 2Skin & Laser Surgery Center of New England, Rejuvenation Center, 4Laser Skin and Vein Institute, and 5Centre Laser Dermatologie Phlébologie Abstract Objectives: This study evaluated the efficacy and safety of a low-level, dual-wavelength laser energy and massage device for improving the appearance of cellulite and reducing thigh circumference. Methods: Subjects (n ⫽ 83) with mild to moderate cellulite enrolled in this IRB-approved, open-label, multicenter study. Their right or left thighs received eight treatments with a low-level, dual-wavelength laser and massage device. The untreated contralateral thigh served as a control. Circumferences of the upper, middle, and lower thighs (treated and untreated) were measured before the fifth and eighth treatments and 1 month after the final treatment. Results: Reduction in thigh circumference of the treated areas exceeded those of the control areas for the upper, middle, and lower thigh in most subjects. The maximum reduction (–0.82 cm) occurred in the upper thigh at 1 month. The mean reduction of the upper, middle, and lower thigh circumferences was –0.64 cm for the treated thighs compared to –0.20 cm for untreated thighs. The difference was significant (p ⬍ 0.0001). Fifty-nine (71.1%) treatment thighs lost circumference compared to 44 (53.0%) control thighs. Resolution of adverse effects including erythema, swelling, and increased urination was seen within 30 minutes after treatment. All were resolved without sequelae and within the expected duration. Conclusion: The low-level, dual-wavelength laser energy and massage device safely improves the appearance of cellulite while reducing thigh circumference. Key Words: cellulite, circumference, low-level laser, massage Introduction A major cosmetic concern, cellulite is found in approximately 85% of postpubertal women (1). Women with this condition present with irregular skin dimpling, most frequently on the thigh and buttocks, that resembles cottage cheese (2) or orange peels. Enlarged adipocytes, weakened connective tissue, and reduced microcirculation have been implicated in the pathogenesis of cellulite (3,4). Although cellulite occurs in both slim and obese persons, the condition can be accentuated by excess body weight (1,3). A variety of non-invasive devices are FDA-cleared for temporarily improving the appearance of cellulite. These include a handheld device that kneads the skin, a device with bipolar radio frequency (RF) and infrared (IR) energy that can also massage the skin, a low-fluence 810-nm diode laser with vacuum massage capability, a vacuum massage device with or without a 660–880-nm probe or 880-nm light pad device, and a suction and mechanical massage device that provides 650-nm light and 915-nm laser energy (5). Other modalities include subcision (6,7), mesotherapy and injection lipolysis (8,9), ultrasound- and laser-assisted liposuction (10,11), RF (12), topical aminophylline (9,13), and retinol (14). Scientific proof of efficacy is anecdotal and based on subjective assessments for most of these modalities. This study evaluated the efficacy and safety of a low-level, dual-wavelength laser energy and massage device for the temporary reduction of thigh circumference and, through the use of photographs before and after treatment, improvement in the appearance of cellulite. Correspondence: Michael H. Gold, Tennessee Clinical Research Center, 2000 Richard Jones Road, Nashville, TN 37215, USA. Fax: 1 615 383 1948. E-mail: [email protected] (Received 17 February 2010 ; accepted 26 December 2010 ) ISSN 1476-4172 print/ISSN 1476-4180 online © 2011 Informa UK, Ltd. DOI: 10.3109/14764172.2011.552608 14 M. H. Gold et al. Methods J Cosmet Laser Ther Downloaded from informahealthcare.com by HINARI on 03/30/11 For personal use only. Subjects Subjects (n ⫽ 83, all women; mean age 39.7 years [37.8 to 41.6, 95% CI]) with mild to moderate cellulite on the thighs enrolled in this open-label, multicenter study. Subjects maintained a stable body weight during the previous 6 months and were required to maintain their baseline food and activity patterns during the study period. Subjects’ average weight at study entry was 139.4 ⫾ 18.0 pounds (range 108.1–219.1). The median body mass index (BMI) value at baseline was 23.10 (interquartile range [IQR] ⫽ 3.57). Sixty-one (73%) of subjects had normal (18.5–24.9) BMI levels. Weights were measured at baseline and at the final (eighth) treatment visit. Subjects completed a relevant medical history questionnaire and underwent a cutaneous examination. Exclusion criteria included pregnancy, lactation, coagulation disorders, serious systemic disease, dermatologic conditions requiring treatment in the target areas, history of neuropathy, anti-cellulite treatment during the past 3 months, and daily use of aspirin or corticosteroids. All subjects provided written informed consent to treatment. The study was approved by the Western Institutional Review Board. Treatment device A low-level, dual-wavelength laser and massage device (SmoothShapes; Eleme Medical, Merrimack, NH, USA) was used in this study. The proprietary combination of the 650 and 915-nm wavelengths with vacuum and contoured rollers for massage is called Photomology™ (15,16). The handpiece, or photomology module, includes two rollers, a vacuum chamber, four 650-nm lightemitting diodes (LEDs), and eight 915-nm laser diodes. The rollers manipulate and smooth the skin to facilitate fluid and fat mobilization and enhance lymphatic drainage as well as microcirculation. The suction level is selectable up to 500 millibars (375 mmHg). Motion sensors in the handpiece stop light emission if the module is not in firm contact with the skin and moving, ensuring that skin temperatures never exceed 40°C during treatment. Treatment procedure The authors applied dual-wavelength laser energy, vacuum, and controlled mechanical massage simultaneously to the target areas. The right or left thighs of subjects received eight treatments, always at a maximum power setting of 10 W. Subjects were treated twice weekly for 4 weeks, for a total of eight treatments. The contralateral thigh was not treated and served as a control. The treatment thigh was randomly assigned with a random integer table. Subjects who were randomly assigned an even number had their left thigh treated and subjects who were assigned an odd number had their right thigh treated. The front and back of each thigh (80-in2 area) were treated for approximately 15 minutes: a total treatment time of 30 minutes per thigh. Subjects received multiple passes with the handpiece in transverse and longitudinal directions. Thigh circumference Measurements were taken at baseline before treatment, just before treatments five and eight, and 1 month after treatment eight (final). Circumferences were measured at three thigh positions: the lower, middle, and upper areas. Vertical heights of each measurement were determined at baseline with a laser level device and recorded in the subject’s chart for accuracy and reproducibility during subsequent measurements. One person, trained by Eleme staff, performed all measurements at each site, and the three positions measured were identical for each subject over time. A spring-loaded tape was used to ensure that the tension of the tape was constant. The person who measured thigh circumferences was blinded to which thigh was being treated. Preliminary evaluation Circumferential reduction was evaluated by comparing circumferences of the lower, middle, and upper thighs before the initial treatment with circumferences at the final treatment for both the treated and untreated thighs. Differences in circumferences were evaluated for significance by the paired t-test, using p ⬍ 0.05 as the cut-off level. Improvement in cellulite appearance was evaluated by comparing pre-treatment photographs with post-treatment photographs. Data were also collected for subjects who returned for a 3-month follow-up visit. Data combination Thigh circumferences were also quantified by combining the upper, middle and lower measurements in three ways: (i) mean circumference (arithmetic average of the three measurements), (ii) sum of the three measurements, and (iii) estimated volume (constant slope and fixed height [13 cm] assumed from upper to lower measurements). Changes from baseline were evaluated at just before treatment five, just before treatment eight, and 1 month after the final (eighth) treatment. Improvement in cellulite with laser and massage 15 Table I. Mean reductions in circumference for treated and control thighs. 1 Month Location on thigh Upper Middle Lower Mean of upper, middle, and lower 3 Months T C p-value T C –0.82 –0.69 –0.40 –0.64 –0.23 –0.22 –0.17 –0.20 ⬍ 0.0001 (s) ⬍ 0.0001 (s) 0.0062 (s) ⬍ 0.0001 (s) –0.35 –0.46 –0.14 –0.32 0.11 –0.04 –0.02 –0.02 p-value 0.0001 ⬍ 0.0001 0.2397 ⬍ 0.0001 (s) (s) (ns) (s) T ⫽ treatment; C ⫽ control; s ⫽ significant; ns ⫽ non-significant. Results J Cosmet Laser Ther Downloaded from informahealthcare.com by HINARI on 03/30/11 For personal use only. Thigh circumference reduction All 83 subjects completed the 1-month follow-up visit. As shown in Table I, reductions in mean thigh circumference of the treated areas exceeded those of the control areas for the upper, middle, and lower thigh in all cases. The maximum reduction (–0.82 cm) occurred in the upper thigh at 1 month (Figure 1). The mean reduction of the upper, middle, and lower thigh circumferences was –0.64 cm for treated thighs compared to –0.20 for control thighs at 1 month (Figure 2). Clinical examples are presented (Figures 3–5). At 1 month, reductions in the treated thighs were significantly higher than those of the control thighs in all cases. The 3-month data must be regarded as preliminary since only 72 subjects returned at this time. As shown in Table I, circumferential reductions of the treated thighs were significantly greater than the untreated thighs for the upper and middle areas, and for the mean of all three thigh locations. Combination of data As stated earlier, thigh circumferences were also quantified by combining the upper, middle and lower measurements in three ways: (i) mean circumference, (ii) sum of the three measurements, and (iii) estimated volume. Mean ⫾ SD data are presented in Table II for each of these three calculations at each time point. There were no missing data. Repeated measures analyses of variance (ANOVAs) were conducted on each measurement. In each Figure 1. Mean reductions in thigh circumference for treated areas of the upper, middle, and lower thighs at 1 month. (RIC ⫽ reduction in circumference.) instance, the group (treated vs control thigh) ⫻ time (baseline, treatment five, treatment eight, 1-month follow-up) interaction was significant (p ⬍ 0.001), suggesting that circumference reduction was greater in the treated thigh. For each set of analyses, the cutoff level was set at p ⫽ 0.05/3), or 0.017, rather than 0.05 because three tests were being conducted within each set of analyses. Means ⫾ SD for changes from baseline for each of the three measurements are shown in Table III. Percent reduction For mean circumference, sum of the three measurements, and estimated volume, follow-up tests were conducted for the percent changes from baseline to take into account minor baseline differences between groups. Matched pair t-tests were used to assess the significance of change from baseline, comparing treated to control thigh. Differences were significant (p ⬍ 0.001) at each time point. Mean percent changes from baseline for each of the time points are shown in Table IV. The 1-month follow-up data (Table III) are summarized in Table V with 95% confidence intervals (CIs). As indicated previously, the differences between treated and control thighs were significant for each of the three measurements. Circumference changes by category Thirteen treatment thighs (15.7%) showed a circumference loss of 2 cm or more as compared to three Figure 2. Mean reductions in thigh circumference for treated and control areas of upper, middle, and lower thighs at 1 month. (RIC ⫽ reduction in circumference.) J Cosmet Laser Ther Downloaded from informahealthcare.com by HINARI on 03/30/11 For personal use only. 16 M. H. Gold et al. Figure 3. The left lateral thigh of a 29-year-old female before treatment (left) and 1 month after eight treatments (right). Circumferential reductions were 2.1, 2.6, and 1.1 cm for the upper, middle, and lower thigh, respectively. Photographs courtesy of Dr Khalil Khatri. Figure 5. The posterior thigh of a 32-year-old female before treatment (left) and 1 month after eight treatments (right). Circumferential reductions were 3.2, 1.7, and 1.2 cm for the upper, middle, and lower thigh, respectively. Photographs courtesy of Dr Robert Weiss. (3.6%) control thighs. Nineteen treatment thighs (22.9%) lost between 1.0 cm and 1.99 cm, as compared to 15 (18.1%) control thighs. In summary, 59 (71.1%) treatment thighs lost circumference compared to 44 (53.0%) control thighs; 24 (28.9%) treatment thighs added circumference versus 39 (47.0%) control thighs during the study. Table VI provides a categorical cross tabulation of average circumference change from baseline to follow-up providing a paired (within subject) analysis. Each entry represents a specific number of subjects in both groups. For example, three (3.6%) subjects lost 2 cm or more in both thighs and 22 (26.5%) subjects gained circumference in both thighs. Changes in body weight Figure 4. The posterior thigh of a 27-year-old female before treatment (left) and 1 month after eight treatments (right). Circumferential reductions were 4.0, 3.5, and 2.4 cm for the upper, middle, and lower thigh, respectively. Photographs courtesy of Dr Khalil Khatri. The weight of all subjects was measured at baseline and at treatment eight. Seventy subjects (84%) maintained their weight to within 5 pounds (2.3 kg) of their pretreatment weight. Thirteen subjects (16%) gained 5 or more pounds (2.3 kg or more) during the study. For subjects who achieved a reduction in circumference in the treated thigh, the mean weight of the responders did not differ significantly from the mean weight of the non-responders (p ⫽ 0.0883). Mean circumferential reductions were –1.16 cm for the treated thighs and –0.56 cm for control thighs. For subjects who showed an increase in circumference for the treated thigh (n ⫽ 22), the mean weight gain was 2.936 pounds (1.3 kg), which was significant (p ⫽ 0.0080). For this group, the mean increase in thigh circumference was 0.70 cm for treated thigh and 0.67 cm for the control thigh. Food and drink intake and exercise information was requested from subjects; however, only 38 (46%) complied. This information did not prove to be useful. Improvement in cellulite with laser and massage 17 Table II. Mean circumference, summed circumference, and volume for both groups at the indicated treatment visits. Treatment visit (mean [SD]) Measurement Mean (cm) treated thigh control thigh Sum (cm) treated thigh control thigh Volume (ml) treated thigh control thigh Baseline Treatment 5 Treatment 8 1-Month follow-up 49.00 (3.42) 48.86 (3.51) 48.62 (3.38) 48.73 (3.49) 48.62 (3.40) 48.75 (3.57) 48.37 (3.55) 48.65 (3.74) 147.01 (10.26) 146.57 (10.53) 145.85 (10.14) 146.20 (10.46) 145.85 (10.21) 146.24 (10.72) 145.10 (10.64) 145.96 (10.64) 2534.40 (379.59) 2516.77 (395.38) 2497.65 (373.31) 2501.12 (389.22) 2487.08 (373.91) 2510.52 (397.21) 2465.86 (393.74) 2496.41 (413.36) J Cosmet Laser Ther Downloaded from informahealthcare.com by HINARI on 03/30/11 For personal use only. Adverse effects Resolution of adverse effects including erythema, swelling, and increased urination was seen within 30 minutes after treatment. All were resolved without sequelae and within the expected duration. Discussion The results of the present study confirm those of Lach (17) in which the combination of low-level, dual-wavelength laser with massage prototype provided significantly greater reduction in subcutaneous fat than massage alone, as shown by magnetic resonance imaging (MRI). The 650-nm light increases collagen production, reduces edema, increases cell membrane permeability, and relieves pain inflammation, all without destroying fat cells (18–20). The 915-nm energy selectively heats fat (21) and promotes wound healing (22). The vacuum-assisted mechanical massage facilitates the mobilization of interstitial fluid and fat, promotes lymphatic flow as well as subcutaneous blood flow, all of which promotes a healthier more collagenic tissue. The massaging facilitates the movement of fat toward and into the lymphatic system while the contoured rollers promote lymphatic drainage (17). Although not evaluated in the present study, this device is also used for the relief of minor muscle aches and pain, relief of muscle spasms, and temporary improvement of local blood circulation. Unlike Lach, we based our results on changes in measured thigh circumferences before and after treatment rather than MRI. As shown in Table VII, our thigh circumference reductions are in general agreement with those of Alster and Tanzi (23) with their combination of RF, IR, and massage, and with those of Sadick and Magro (24) with the same device. Alster and Tanzi treated the ‘upper anteromedial and posterolateral thigh’ while Sadick and Magro treated the upper and lower thigh. Both studies included an untreated control, as in our study. Since the remaining studies in Table VII did not include a control, it is difficult to compare our results with theirs. Sadick and Magro reported a 0.84-cm mean decrease in the upper thigh circumference and a 0.5cm decrease in the lower thigh. In our study (Table I), the corresponding mean reductions were 0.82 and 0.40 cm, indicating that the reductions in the upper thighs were greater than those of the lower thighs in both studies. Sadick and Magro also reported that 71.87% of treated subjects achieved a decrease in overall thigh circumference, which compares well with the 71.1% of similar subjects in our study. Sadick and Magro also reported that the greatest reduction in thigh circumference occurred at 4 weeks, Table III. Changes from baseline in mean circumference, summed circumference, and volume. Change (mean [SD]) Measurement Mean (cm) treated thigh control thigh Sum (cm) treated thigh control thigh Volume (ml) treated thigh control thigh Baseline to treatment 5 Baseline to treatment 8 Baseline to 1-month follow-up –0.39 (0.70) –0.12 (0.76) –0.39 (0.76) –0.11 (0.78) –0.64 (1.07) –0.20 (1.04) –1.16 (2.11) –0.37 (2.29) –1.16 (2.27) –0.33 (2.34) –1.91 (3.20) –0.61 (3.13) –36.75 (95.57) –15.64 (95.57) –47.32 (102.19) –6.24 (110.68) –68.54 (124.63) –20.35 (123.09) 18 M. H. Gold et al. Table IV. Percent change from baseline for mean circumference, summed circumference, and volume. Change (mean [SD]) Measurement Baseline to treatment 5 Baseline to treatment 8 Baseline to 1-month follow-up –0.77 (1.45) –0.24 (1.59) –0.78 (1.54) –0.22 (1.62) –1.30 (2.18) –0.43 (2.17) –0.77 (1.45) –0.24 (1.59) –0.78 (1.54) –0.22 (1.62) –1.30 (2.18) –0.43 (2.17) –1.38 (3.81) –0.52 (3.81) –1.80 (3.99) –0.17 (4.47) –2.73 (4.94) –0.82 (4.96) J Cosmet Laser Ther Downloaded from informahealthcare.com by HINARI on 03/30/11 For personal use only. Mean (cm) treated thigh control thigh Sum (cm) treated thigh control thigh Volume (ml) treated thigh control thigh and that the decrease immediately after treatment and at treatment eight was not significant. In the present study, the reductions of all thigh areas appear to reach a maximum at 1 month (Table I) but may begin to decline at 3 months. This trend is consistent with the data of Sadick and Magro that the greatest reduction appears to be at 1 month, and that repeat treatments would be necessary to maintain the maximum reduction. Regarding the combination data, each outcome variable attempts to incorporate information from all three measurements taken on each subject during the study. However, in light of the differential loss across the upper, middle and lower sites, it is obvious that the outcome is much influenced by where the measurement is taken. The upper site appears to be most amenable to treatment. The summed measurement is not directly comparable to that used for devices in Table VII, and would appear to, perhaps, take advantage of redundant information. The volume calculation incorporates information from all three measurements, and has no redundancy. It is estimated because the actual configuration of the thigh is not considered. However, it may be the most accurate (average) depiction of changes affected by the treatment. The average volume loss in the treated thighs from baseline to 1-month follow-up is Table V. Mean changes at 1 month with 95% confidence intervals (CIs). Measurement Mean (cm) treated thigh control thigh Sum (cm) treated thigh control thigh Volume (ml) treated thigh control thigh Mean change from baseline to 1-month follow-up 95% CI –0.64 –0.20 –0.87 to –0.41 –0.43 to ⫹0.02 –1.91 –0.61 –2.62 to –1.22 –1.29 to ⫹0.07 –68.54 –20.35 –95.75 to –41.34 –47.34 to ⫹6.52 –68.54 ml (–95.75 to –41.34). This is equivalent to a loss of 2.73% (–3.81% to –1.65%) during treatment, commensurate with a loss of 1 cm from a 50-cm thigh (2.0%). For subjects who showed an increase in thigh circumference for the treated thigh (n ⫽ 22), the mean weight gain (2.936 pounds [1.3 kg]) was significant (p ⫽ 0.0080). The significant increase in body weight suggests that at least part of the increase in thigh circumference in the control group may be attributed to weight gain during the study period. The strengths of the present study are the large number of subjects, the inclusion of an untreated control, measurement of thigh circumferences at three levels, and body weight data at the beginning and end of the study period. Thigh circumference is considered an indicator of cellulite product efficacy (1,26). For subjects who achieved a reduction in circumference in the treated thigh (n ⫽ 57), the mean weight of the treated group did not differ significantly from the mean weight of the non-responders (p ⫽ 0.0883). This suggests that the reduction in thigh circumference cannot be attributed to weight loss. The explanation for the loss in thigh circumference (0.1–2.0 cm or more) in 53% of control thighs of the present study is unclear. Sadick and Magro (24) noted that 37.5% of control subjects showed a 0.5–1.5-cm reduction in upper thigh circumference and 43.75% showed a 0.5–2.5-cm reduction in lower thigh circumference. Weight loss among subjects was not significant. The authors indicated that the reason for the circumferential reduction was ‘difficult to pinpoint’, although the reduction was more dramatic in the treated thighs, as in the present study. The greater percentage of subjects in the present study (53% vs 37.5% and 43.75% in the study of Sadick and Magro) whose control thighs showed a circumferential reduction may be due to differences in the number of subjects (83 vs 20) and in the anatomical location at which circumferences were measured. Alster and Tanzi (23) reported no measurable reduction in the control thighs before and after treatments. Improvement in cellulite with laser and massage 19 Table VI. Cross tabulation of categorized average circumference change from baseline to follow-up for treated and control thighs. Control thigh (%) J Cosmet Laser Ther Downloaded from informahealthcare.com by HINARI on 03/30/11 For personal use only. Treated thigh (%) Loss of 2.0 cm or more Loss of 1.0–1.99 cm Loss of 0 0.1–1.0 cm Gain Total Loss of 2.0 cm or more Loss of 1.0–1.99 cm Loss of 0.1–1.0 cm 3 (3.6) 6 (7.2) 4 (4.8) 0 0 0 3 (0) (0) (0) (3.6) 5 3 1 15 Limitations of the present study are that the improvement in cellulite appearance is supported only by clinical photographs taken before and after treatment. Numerical data other than thigh circumference reduction are not presented. However, the authors feel that for the treatment of cellulite, clinical significance is best evaluated by photographs of actual results. Although the thigh circumference reductions in the present study appear modest, they are consistent with those of published studies (23,24) in which a control was included. The authors support Sadick and Magro (24) in their assertion that ‘positive results are not solely based on thigh circumference but that the smoothness and appearance of the thigh is particularly significant as well’. The author cautions practitioners that the device used in the present study temporarily improves cellulite. Although patients desire more permanent (6.0) (3.6) (1.2) (18.1) 10 11 1 26 (12.0) (13.3) (1.2) (31.3) Gain 0 (0) 4 13 22 39 (4.8) (15.7) (26.5) (47.0) Total 13 (15.7) 19 (22.9) 27 (32.5) 24 (28.9) 83 (100) results, they will pursue treatment even if the improvement is temporary because non-invasive technologies that permanently eliminate cellulite are not available. The objective of the present study was to evaluate the efficacy and safety of the laser–vacuum combination for the temporary reduction of thigh circumference and, through the use of photographs before and after treatment, improvement in the appearance of cellulite. It may be argued that for a device with two different technologies (laser and vacuum) an alternative protocol would have been to treat one side with vacuum and the other side with the vacuum– laser combination. Such a study would show if the laser enhanced the results achieved by the vacuum alone. Although the present study was not designed to answer this question, a vacuum alone versus vacuum–laser protocol may be appropriate for a future study. Table VII. Reduction in thigh circumferences (RIC) by methods to improve the appearance of cellulite. Reduction in circumference compared to pre-treatment value (cm) Reference Device No. of treatments Alster and Tanzi (23) (n ⫽ 20) Sadick and Magro (24) (n ⫽ 16) massagea RF, IR, RF, IR, massagea 8 12 Goldberg et al. (25) (n ⫽ 30) Bielfeldt et al. (26) (n ⫽ 34) Unipolar RFc Cosmetic anti-cellulite product (rub-on) TriPollar RFd Massage, lymphatic drainage, or connective tissue manipulation LPG endermologie Low-level, dualwavelength laser with massage Low-level, dualwavelength laser with massage 6 Twice-daily Manuskiatti et al. (27) (n ⫽ 21) Tunay et al. (28) (n ⫽ 60) Güleç (29) (n ⫽ 33) Lach (17) (n ⫽ 74) Present study 8 15–20 Mean (control), time point p-value –0.8 (0), 6 months –0.5 (–0.28) and –0.84 (0.0625)b, 12 weeks –2.45 (none), 6 months –1.5 (none), after 4 weeks of treatment –1.71 (none), 4 weeks –0.50 (none), immediately after treatment – ⬍ 0.01 – ⬍ 0.001 0.002 ⬍ 0.05 15 14 –2.2 (none), after treatment –0.09 (none untreated) ⬍ 0.001 – 8 –0.40 (–0.17) and –0.82 (–0.23),b 1 month ⬍ 0.0001 n ⫽ number of subjects; RF ⫽ radio frequency; IR ⫽ infrared. aVelaSmooth, Syneron Medical, Yokneam, Israel; bLower and upper thigh, respectively; cAlma Lasers, Buffalo Grove, IL, USA; dRegen, Pollogen Ltd, Tel Aviv, Israel. 20 M. H. Gold et al. The device in the present study safely improves the appearance of cellulite as shown by clinical photographs, statistically significant reductions in thigh circumference in the present study, and by MRIproven fat reduction in the study of Lach (17). The encouraging results warrant additional studies with more subjects. 13. 14. 15. 16. Conclusion The low-level, dual-wavelength laser energy and massage device safely improves the appearance of cellulite while reducing thigh circumference. J Cosmet Laser Ther Downloaded from informahealthcare.com by HINARI on 03/30/11 For personal use only. 17. Financial disclosures Each author has received research support from Eleme Medical, Inc. 18. 19. References 1. Draelos Z, Marenus KD. Cellulite. Etiology and purported treatment. Dermatol Surg. 1997;23:1177–81. 2. Rosenbaum M, Prieto V, Hellmer J, Boschmann M, Krueger J, Leibel RL, et al. An exploratory investigation of the morphology and biochemistry of cellulite. Plast Reconstr Surg. 1998;101:1934–39. 3. Avram MM. Cellulite: A review of its physiology and treatment. J Cosmet Laser Ther. 2004;6:181–5. 4. Draelos Z. The disease of cellulite. J Cosmet Dermatol. 2005;4:221–2. 5. Wanner M, Avarm M. 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