1. Treatment of Cellulite with the Swiss Dolorclast

2. Preface The application settings outlined herein (handpiece, applicator, number of treatments, number of impulses per treatment, frequency, air pressure) are non-binding recommendations. They are based on reports by experts in the field. Patients should not experience dyscomfort, or feel pain, when treated for cellulite. This is because treatment for this indication with radial shock waves does not aim at activating the peripheral nervous system. The Swiss Dolorclast Smart is approved for the treatment for cellulite. The corresponding approval of the Swiss Dolorclast Classic and Master is pending.

3. Cellulite – brief introduction

4. Clinical picture Picture taken from http://en.wikipedia.org/wiki/File:Cellulite-2.jpg

5. Histology Picture taken from www.istockphoto.com/stock-photo-2643756-cellulite-cross-section.php © www.istockphoto.com Cellulite Smooth skin

6. Definition, Epidemiology, Etiology  Topographic skin change, evident by skin dimpling and nodularity  Occurence mainly in women on the –pelvic region –lower limbs –abdomen  Presentation as herniation of subcutaneous fat with fibrous connective tissue  Occurence in 80-90% of the postpubertal females  Rarely seen in males

7. Cause  Poorly understood  Potential contribution: –Changes in metabolism and physiology –Alterations of connective tissue structure hormonal factors genetic factors the microcirculatory system the extracellular matrix –Subtle inflammatory alterations

8. Predisposition  Gender (females > males)  Race (caucasians > african americans / hispanics)  Biotype  Distribution of subcutaneous fat  Predisposition to lymphatic and circulatory insufficiency

9. Grading  Grade 1: minimal dimples / surface inhomogeneities  Grade 2: orange peel appearance, thinned epi-/dermis  Grade 3: dimples / micronodules / striations  Grade 4: palpable macronodules / striations  Note: other authors may use different gradings

10. Treatment options (1) Khan et al., J Am Acad Dermatol 2010;62:373-384:  Treatment modalities range from topical creams to invasive procedures, such as laser-assisted lipolysis and liposuction  There is no single treatment of cellulite that is completely effective  Future treatment options for cellulite depend upon our understanding of the molecular basis and hormonal influences of cellulite adipose tissue

11. Treatment options (2) Levels in Evidence-Based Medicine IA: Meta-analysis of randomized clinical trials (RCTs) that had enough power to demonstrate a statistically significant health outcome IB: RCTs that had enough power to demonstrate a statistically significant health outcome II: RCTs trials with results that were not statistically significant but where a larger trial might have shown a clinically important difference III: Nonrandomized concurrent cohort comparisons between contemporaneous patients IV: Nonrandomized historical cohort comparisons between current patients and former patients (from the same institution or from the literature) V: Case series without control subjects

12. Treatment options (3) Treament options and corresponding Evidence levels  Weight loss (Level II)  Endemology (Level II)  Liposuction (Level III)  Subcision (Level IV)  Mesotherapy (Level II)  Topical phospotidylcholine and LED (Level IA)  Radiofrequency devices (Level II)  Ultrasound (Level II)  Laser-assisted lipolysis (Level IA)  Topical herbs and retinol (Level II)  Carboxy therapy (Level II)  Cryolipolysis (Level IV)

13. Why treatment for cellulite with shock waves? Preliminary reports in the literature, describing treatment for cellulite with extracorporeal shock waves (single case studies and case series)  Angehrn et al., Clin Interv Aging 2007;2:623-630 (Level V)  Christ et al., Aesthet Dermatol 2008:1:6-14 (Level III)  Christ et al., Aesthet Surg J 2008;28:538-544 (Level III)  Kuhn et al., Clin Interv Aging 2008;3:201-210 (Level V)  Sattler et al., Aesthet Dermatol 2008;2:17-25 (Level III)

14. Recommended treatment protocol for cellulite using the Swiss Dolorclast

15. 15 Application of coupling gel (no need for palpation and labeling because the treatment area is visually identified) Treatment protocol (1)

16. 16 Treatment protocol (2) Treatment with the Power + handpiece Applicator: 36 mm Planar Number of treatments: 8 (two treatments per week) Number of impulses per treatment: 200 – 300 per cm 2 cellulite skin (approximately 3,500 per skin region) Frequency: 8 - 20 Hz Air pressure: 3 - 4 bar Literature: EMS (ongoing clinical study)

17. Results achieved with the recommended treatment protocol (pilot study)

18. Results Patient # AgeBody Mass Index (BMI) Pain (VAS score) (a) Comfort during treatment (b) Satis- faction about treatment (b) Cellulite Stage before treatment Cellulite Stage after treatment Cellulite Stage - difference 13421.83.5752.511.5 23520.83562.51.51 33824.69 (c) -- (c) 45520.317721.50.5 54821.94572.51.51 65122.93582.50.52 72932.925531.5 82331.63832.75 0 95719.735732.50.5 105122.25562.751.51.25 112920.825121.50.5 124320.43572.51.51 135124.23772.51.51 14419.63862.51.51 154318.746121.750.25 Average : 41.822.83.05.95.42.51.570.9 (a) 0 = no pain; 10 = maximum pain (b) 0 = worst; 10 = best (c) drop-out because of pain

19. Conclusions (from our pilot study – Level V ) Treatment for cellulite with the Swiss Dolorclast is  safe  efficient in patients with cellulite grades 2 and 3  able to reduce the cellulite grade by one grade on average Treatment outcome does not correlate with age, body height, body weight, and BMI Treatment outcome is not permanent but lasts for several months