The efficacy of the treatment of abdominal cellulite and skin tightening with a Venus Freeze (MP) 2 -A pilot study.

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The efficacy of the treatment of abdominal cellulite and skin tightening with a Venus Freeze (MP) 2 -A pilot study. Rungsima Wanitphakdeedecha, MD, MA, MSc Department of Dermatology Faculty of Medicine Siriraj Hospital, Mahidol University Bangkok, THAILAND

LOGO Cellulite v An architectural disorder of adipose tissue v Characterized by the padded and nodular appearance of skin v Cellulite-prone areas Posterolateral thigh Pelvic region Abdomen Skin Res Technol 2002;8:118-24.

Pathophysiology of cellulite v Weakened connective tissues v Low metabolic rate of adipocytes v Deterioration of the dermal vasculature excessive fluid retention vascular compression and hypoxia J Am Acad Dermatol. 2010; 62(3): 361-70; quiz 371-2.

LOGO Treatments of cellulite

Background v The Venus Freeze (MP 2 ) combines Multipolar radiofrequency current and Pulsed Magnetic Fields in synergy. v Multi-polar radiofrequency 8 electrodes Raise the temperature of treatment area quickly and homogenously v Pulsed Magnetic Field Stimulate molecular and cellular activities and reactions Increase fibroblast derived collagen production J Med Invest. 2008;55:267-78. Biochem Biophys Acta. 1985 Jan 28;838:98-105. FASEB J 2004; 18:1231-3.

Objective v To determine the efficacy of a Venus Freeze (MP 2 ) in treatment of abdominal cellulite and skin tightening

Subjects v 25 subjects v Inclusion criteria Females with abdominal cellulite grade II-III Age 18-65 years old Never received any treatments v Exclusion criteria Pregnancy and lactation Patients with pace maker or implant Any skin lesions in the treatment area Receive oral isotretinoin within 6 months

LOGO Methods v 8 weekly treatments v 30 minute for each treatment sessions

Evaluations (baseline, 1-, 4-, and 12-week after treatment) v Objective Body weight and abdominal circumference at umbilical level Subcutaneous tissue thickness by ultrasound at baseline and 1-week after treatment v Subjective Physician assessment with standardized photographs Patient satisfaction rating

RESULTS

Results v All subjects finished 8 treatments 3-month follow up visit.

Demographic data v Mean(SD) age: 37.56(6.8) years old v BMI: 19.5-34.4 v Fitzpatrick skin type III : 3(12%) IV : 22(88%)

Treatment data v All patients experienced post operative erythema. Mild: 3(12%) Moderate: 22(88%) v No immediate post operative complication was found.

Body weight 60.0 P=0.44 Wt.(Kg) 59.0 58.0 57.0 57.5 57.4 57.2 57.3 57.3 57.4 57.2 57.5 56.6 56.7 57.1 56.0 55.0 Tx1 Tx2 Tx3 Tx4 Tx5 Tx6 Tx7 Tx8 FU1 FU2 FU3 Repeated measure ANOVA

Body weight Body weight (kg) Mean (SD) % cumulative weight reduction Tx.1 57.51 (6.67) Tx.2 57.38 (6.46) 0.18 (1.10) Tx.3 57.22 (6.60) 0.49 (1.45) Tx.4 57.32 (6.62) 0.31 (1.24) Tx.5 57.32 (6.60) 0.33 (1.44) Tx.6 57.38 (6.60) 0.22 (1.38) Tx.7 57.23 (6.56) 0.45 (1.69) Tx.8 57.48 (6.66) 0.46 (1.90) FU1 56.64 (6.39) 0.79 (2.22) FU2 56.73 (6.26) 0.62 (1.76) FU3 57.11 (6.68) 0.69 (2.30)

Abdominal circumference P<0.001(at least) 84.5 84 83.5 83 82.5 82 81.5 81 80.5 80 83.9 82.7 82.9 82.9 82.9 82.8 82.6 82.4 82.4 82.1 82.0 81.5 81.5 81.7 82.0 82.0 82.0 81.7 81.5 Tx1 Tx2 Tx3 Tx4 Tx5 Tx6 Tx7 Tx8 FU1 FU2 FU3 before after Paired samples t-test

Abdominal circumference Abdominal circumference (cm.) Mean (SD) % cumulative circumferential reduction Tx.1 83.88 (6.15) Tx.2 82.72 (5.84) 1.35 (1.75) Tx.3 82.92 (5.72) 1.09 (1.93) Tx.4 82.92 (5.65) 1.08 (2.41) Tx.5 82.92 (5.89) 1.10 (2.13) Tx.6 82.60 (6.04) 1.50 (2.15) Tx.7 82.44 (5.99) 1.69 (2.17) Tx.8 82.80 (5.81) 1.23 (2.56) FU1 81.48 (5.87) 2.82 (2.42) FU2 82.12 (6.17) 2.08 (2.63) FU3 81.96 (6.35) 2.27 (2.97)

ULTRASONOLOGIC EVALUATION

Axial and sagittal plane Axial Sagittal cellulite fat muscle cellulite fat muscle

Patient no. 22 PreTx1 1 week FU

PreTx1 1 week FU

Patient no. 22: Axial plane PreTx1 1 week FU : cellulite 0.870 0.621 : fat 0.936 0.739 : total subcutaneous 1.810 1.410 (cm)

Patient no. 22: Sagittal plane PreTx1 1 week FU : cellulite 1.010 0.857 : fat 1.040 0.779 : total subcutaneous 2.060 1.640 (cm)

Cellulite thickness (Axial plane) p=<0.001 PreTx1 (cm) FU 1 week (cm) Paired samples t-test

Fat thickness (Axial plane) p=0.146 PreTx1 (cm) FU 1 week (cm) Paired samples t-test

Total subcutaneous thickness (Axial plane) p=<0.001 PreTx1 (cm) FU 1 week (cm) Paired samples t-test

Cellulite thickness (sagittal plane) p=<0.001 PreTx1 (cm) FU 1 week (cm) Paired samples t-test

Fat thickness (sagittal plane) p=0.005 PreTx1 (cm) FU 1 week (cm) Paired samples t-test

Total subcutaneous thickness (sagittal plane) p=<0.001 PreTx1 (cm) FU 1 week (cm) Paired samples t-test

QUARTILE EVALUATION

No improvement

Slight improvement (1-25%)

Moderate improvement (26-50%)

Good improvement (51-75%)

Improvement after 3 follow-ups patients 12 10 8 6 4 2 0 FU1wk FU4wks FU12wks

Improvement sustainability after three follow-ups: BMI patients 80 70 60 50 40 30 20 10 0 72.2 % BMI<23 27.8 % BMI 23 P=0.021 Fisher s exact test

Improvement sustainability after three follow-ups: baseline abdominal circumference Improvement after three follow ups Baseline abdominal circumference (cm) Mean SD With improvement (n=18) Without improvement (n=7) 81.78 4.9 87.95 7.7 P=0.025 Fisher s exact test

Result after 3 follow-up visits Ultrasonographic evaluation shows significant decreases of - cellulite thickness (both axial and sagittal plane) - fat thickness (sagittal plane) - total subcutaneous thickness (both axial and sagittal plane)

Result after 3 follow-up visits In the group of BMI<23, there is significant higher percentage of patients who sustained improvement (p=0.021) The group of sustained improvement has significant lessor baseline abdominal circumference (p=0.025)

Age, skin type, degree of erythema reaction and power used in a procedure display no significant correlation with improvement of abdominal cellulite and tightening.

Conclusions Multi-polar RF with pulsed electromagnetic field demonstrated the efficacy in abdominal cellulite and fat thickness reduction. Patients with BMI < 23 and lessor baseline abdominal circumference tended to have sustainable abdominal cellulite and fat reduction.