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Ultherapy ® and Radiesse ® Combination Treatment to Improve Skin Laxity and Cellulite Appearance on Buttocks and Thighs Gabriela Casabona Private Practice, São Paulo, Brazil

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Page 1: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Ultherapy® and Radiesse® Combination Treatment to Improve

Skin Laxity and Cellulite Appearance on Buttocks and Thighs

Gabriela Casabona Private Practice, São Paulo, Brazil

Page 2: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

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Disclosure

Dr Casabona has no financial interest in any of the products, devices, or drugs mentioned in this presentation

Page 3: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Cellulite

Cellulite is estimated to affect 80–90% of post-pubertal women Changes in dermal and subdermal fibroelastic tissue

structure contribute to worsening of cellulite with age Treating skin laxity to improve the appearance of

cellulite requires stimulation of new collagen formation and dermal remodeling

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Luebberding S, et al. Am J Clin Dermatol. 2015;16:243–256.

Page 4: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Typical cellulite appearance

Page 5: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Rationale for combining MFU-V and CaHA

Microfocused ultrasound with visualization (MFU-V) delivered by

Ultherapy® System

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Radiesse®

calcium hydroxylapatite (CaHA)

Both have demonstrated collagen-stimulating properties and

improvements in skin laxity in a variety of aesthetic indications

Page 6: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Study aims

To evaluate the effects of combined MFU-V/CaHA skin-tightening treatment on buttock and thigh cellulite appearance To determine whether MFU-V enhances CaHA-induced

neocollagenesis

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Page 7: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Study design

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Study type Retrospectively enrolled case series

Subjects 20 women (18-55 years) with moderate-to-severe cellulite who had undergone MFU-V and CaHA treatment for skin laxity on buttocks and thighs

Treatment MFU-V applied using 4 and 7 MHz transducers at focal depths of 4.5 and 3.0 mm (25 lines/transducer/site)

Immediately after, subdermal injections of CaHA diluted 1:1 with 2% lidocaine solution at same site using microdroplet fanning technique (1 ml/site)

One subject scheduled for thighplasty received treatment with six different CaHA:lidocaine dilutions (0.3 ml/5 cm2) followed by MFU-V

Tissue specimens from each dilution site were stained with picrosirius red solution and examined under polarized light microscopy for estimation of amounts of collagen type I, type III and total collagen

Study endpoints Photographs taken at baseline and at 90 days and graded by 2 independent, blinded evaluators using Hexsel Cellulite Severity Scale1

Patient satisfaction questionnaire

1. Hexsel DM et al. J Eur Acad Dermatol Venereol. 2009;23:523–528..

Page 8: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Significant improvements observed for each item on cellulite severity scale

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CSS item Evaluator 1

Baseline 90 Days Between-group

difference

P value

No. of depressions 2.00 (0.73) 1.10 (0.79) -0.90 (0.31) <0.001

Depth of depressions 1.85 (0.81) 0.95 (0.69) -0.90 (0.72) <0.001

Appearance of skin

surface alterations

1.65 (0.99) 0.70 (0.86) -0.95 (0.60) <0.001

Grade of skin laxity,

flaccidity or sagging

1.65 (0.75) 0.70 (0.66) -0.95 (0.51) <0.001

Nürnberger and Müller

classification

2.30 (0.66) 1.50 (0.69) -0.80 (0.41) <0.001

Overall score 9.45 (2.98) 4.95 (3.02) -4.50 (1.00) <0.001

Page 9: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Significant improvements observed for each item on cellulite severity scale

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CSS item Evaluator 1 Baseline 90 Days Between-group

difference

P value

No. of depressions 2.00 (0.73) 1.10 (0.79) -0.90 (0.31) <0.001

Depth of depressions 1.85 (0.81) 0.95 (0.69) -0.90 (0.72) <0.001

Appearance of skin

surface alterations

1.65 (0.99) 0.70 (0.86) -0.95 (0.60) <0.001

Grade of skin laxity,

flaccidity or sagging

1.65 (0.75) 0.70 (0.66) -0.95 (0.51) <0.001

Nürnberger and Müller

classification

2.30 (0.66) 1.50 (0.69) -0.80 (0.41) <0.001

Overall score 9.45 (2.98) 4.95 (3.02) -4.50 (1.00) <0.001

Improvement from moderate-to-severe to mild after only 1 treatment session

Page 10: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Significant improvements observed for each item on cellulite severity scale

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CSS item Evaluator 2

Baseline 90 Days Between-group

difference

P value

No. of depressions 2.00 (0.73) 1.10 (0.79) -0.90 (0.31) <0.001

Depth of depressions 1.85 (0.81) 0.95 (0.69) -0.90 (0.72) <0.001

Appearance of skin

surface alterations

1.65 (0.99) 0.75 (0.97) -0.90 (0.64) <0.001

Grade of skin laxity,

flaccidity or sagging

1.70 (0.80) 0.75 (0.72) -0.95 (0.51) <0.001

Nürnberger and Müller

classification

2.30 (0.66) 1.50 (0.69) -0.80 (0.41) <0.001

Overall score 9.50 (3.07) 5.05 (3.25) -4.45 (1.10) <0.001

Page 11: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Significant improvements observed for each item on cellulite severity scale

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CSS item Evaluator 2 Baseline 90 Days Between-group

difference

P value

No. of depressions 2.00 (0.73) 1.10 (0.79) -0.90 (0.31) <0.001

Depth of depressions 1.85 (0.81) 0.95 (0.69) -0.90 (0.72) <0.001

Appearance of skin

surface alterations

1.65 (0.99) 0.75 (0.97) -0.90 (0.64) <0.001

Grade of skin laxity,

flaccidity or sagging

1.70 (0.80) 0.75 (0.72) -0.95 (0.51) <0.001

Nürnberger and Müller

classification

2.30 (0.66) 1.50 (0.69) -0.80 (0.41) <0.001

Overall score 9.50 (3.07) 5.05 (3.25) -4.45 (1.10) <0.001

Page 12: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

A2

B2

C2

A1

B1

C1

Improvements in cellulite severity

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Page 13: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Improvements in cellulite severity

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A1 A2

B1 B2

A1

A2

Page 14: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Peak total collagen gain with 1:1 CaHA:lidocaine dilution

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Dilutions: A1, B1 (1:0.16), A2, B2 (1:0.3), A3, B3 (1:0.6), A4, B4 (1:1), A5, B5 (1:2), A6, B6 (1:6.5).

CaHA alone (A1-A6) CaHA + MFU-V (B1-B6) Control (C)

Page 15: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Picrosirius-red-stained histologic sections of dermis at 1:1 CaHA dilution

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A4, CaHA alone B4, CaHA+MFU-V

Page 16: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

Patient satisfaction and treatment tolerability

Satisfaction All women reported smoother skin 19/20 reported dimples less visible 19/20 (95%) were satisfied to very satisfied Tolerability MFU-V/CaHA was well tolerated with no severe bruising or

severe pain All women had mild pain with a mean duration of 2 days 18 women had mild bruising which resolved within 1 week

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Page 17: Ultherapy and Radiesse Combination Treatment to Improve ... · Study design 7 Study type Retrospectively enrolled case series Subjects 20 women (18- 55 years) with moderate -to-severe

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Conclusions

MFU-V/CaHA treatment of skin laxity resulted in a significant improvement in cellulite appearance after one procedure Both treatments induce neocollagenesis and elastogenesis

resulting in remodeling of the dermis and collagen structures in the superficial fascia Conversion from collagen type III to type I at 90 days was

greater in tissue sections not subjected to MFU-V, suggesting that complete tissue remodeling may take longer with MFU-V Treatments were well tolerated; subject satisfaction was high MFU-V and CaHA at a 1:1 dilution ratio are an effective

combination for improving skin laxity and cellulite severity in the buttocks and upper thighs