Clinical Research Data

Split Face Study

vs Restylane

Facial Augmentation

Nasolabial Fold

Mental creaseJaw Line

Chin

Post-rhinoplasty

Marionette Line

Cheek

Malar

Radial Lip Lines

Calcium Hydroxylapatite

Gel carrier (~70%)Na carboxymethylcelluloseGlycerine + H2O

Structural component (~30%)Ca+2 PO4 ions (Ca10(PO4)6(OH)2)natural mineral(identical to teeth & bone)

Calcium Hydroxylapatite

Macrophages dissolve gel carrier & fibroblasts form new collagen.

Natural mineral non-antigenic, non-irritant, non-toxic metabolizes via homeostatic mechanisms

WSRS = Wrinkle Severity Rating Scale

No visible fold, continuous skin line.Absent1

Shallow but visible fold with a slight indentation; minor facial feature.

Implant is expected to produce a slight improvement in appearance.Mild2

Moderately deep folds.

Clear facial feature visible at normal appearance but not when stretched.

Excellent correction is expected from injectable implant.

Moderate3

Very long and deep folds; prominent facial feature.

Less than 2mm visible fold when stretched.

Significant improvement is expected from injectable implant.

Severe4

Extremely deep and long folds, detrimental to facial appearance.

2-4mm Visible V-shaped fold when stretched

Unlikely to have satisfactory correction with injectable implant alone.

Extreme5

GAIS = Global Aesthetic Improvement Scale

The appearance is worse than the original condition.Worse

The appearance is essentially the same as the original condition.

No Change

Obvious improvement in appearance from the initial condition, but a touch-up or re-treatment is indicated.

Improved

Marked improvement in appearance but not completely optimal for this patient. A touch-up would slightly improve the result.

Much Improved

Optimal cosmetic result for the implant in this patient.Very Much Improved

Split Face StudyRadiesse vs Restylane (N=50)

• Comparison of durability

– Restylane vs Radiesse

• Nasolabial Folds

– Fold depth WSRS @ 3 or 4– Results from GAIS & Personal Score Card

• Results @ 3, 6 and 9 months

– Trial commenced June 2005

0

0,1

0,2

0,3

0,4

0,5

0,6

0,7

WSRS 3 WSRS 4

Restylane

Radiesse

Split Face StudyVolume Comparison

> 25% less volume

<Volume required

0%

10%

20%

30%

40%

50%

60%

70%

80%

Very Much Much Improved No change Worse

Restylane

Radiesse

Split Face StudyGAIS @ 6 Months

0%

10%

20%

30%

40%

50%

60%

Very Much Much Improved No change Worse

Restylane

Radiesse

Split Face StudyGAIS @ 9 Months

0%

10%

20%

30%

40%

50%

60%

70%

80%

6 Months 9 Months

Restylane

Radiesse

Split Face StudyPersonal Score Card

Results after 1st treatment

Less volume

vsRestylane

vs Restylane