Belotero 1
Belotero 1
Belotero 1
with lidocaine
Optimal
skin
integration
Belotero ®
Its a part
of me
Belotero® Hydro is an ideal treatment option to deliver effective results when patients want
deep rehydration and firmer skin.
The Belotero® range of fillers delivers predictable and harmonious results for the smoothing
and filling of lines and wrinkles, lip augmentation and the restoring of facial volumes.
®
Belotero® – Holistic solution for targeted needs
Elasticity – Cohesivity –
for optimal for excellent
tissue support tissue integration
Plasticity –
for excellent
malleability to
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model and
shape
By optimising the balance of these properties, the Belotero® range of fillers integrates
seamless into the skin tissue and lets you achieve predictable and harmonious results.
®
1
Van Gieson elastin staining
Intelligent design in aesthetics
StandarD cross-linking
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Phase 4 Phase 5
Expansion of the gel that was created Second crosslinking process,
in the crosslinking process supplemented with additional
non-crosslinked hyaluronic acid
This advanced DCLT technology provides the ideal balance of cohesivity, elasticity and
plasticity to match the needs of the targeted layer of the skin.
®
2
Patent family publication number WO2005/085329
Hydro
Belotero ®
Hydro
Skin reh
Comple ydra
xion tio
ra n
dian
ce
Belotero® Hydro* – Designed for rehydration whilst
restoring skin radiance and skin elasticity
H2O
H2O ha a•
ha • ha • h
•
•
•h
Glycerol
a
H2O H2O
•h
Glycerol Glycerol H2O
H2O •h a • ha • ha
a
• ha • •h
ha
ha a •h
•h • ha a•
• h a• a ha • ha
ha • •h
•
ha • ha Glycerol H2O
a
H2O H2O
a
•h
•h
H2O
H2O H2O Glycerol H2O
a
H2O
a•
•h
Glycerol H2O
Glycerol
ha
a
• h H2O H2O
ha • ha • ha • ha • ha
•
H2O
H2O •h
•
a H2O H2O
•h
ha
a Glycerol
•h
a
•h a •h Glycerol
a • ha • ha • h H2O H2O
In vitro tests show the increased resistance against free radical degradation of an HA gel
combined with glycerol.6
100.0
10.00
01.000
G‘ (Pa)
0.100
0.010
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0
0 500.0 1000 1500 1500 2500 3000 3500 time (s)
86%
of females want
to look radiant
and rested7
6
Data on file ®
7
Face Value Wave I (n = 2939) – page 11 –
internal data Merz Pharmaceuticals GmbH
Belotero® Hydro ensures a high level of satisfaction
for you and your patients8
6
Score
6
Score
8
In 2009 a satisfaction enquiry on Mesolis+ gel (equal to
Belotero® Hydro) was conducted on an international level.
During that period, 113 patients and 23 practitioners ®
evaluated the product itself and the quality of the aesthetic
outcomes.
Belotero® Hydro is specifically designed for deep
rehydration treatments
1 st 2 nd 3 rd
Injection Injection Injection
Initial
treatment phase Maintenance phase
2 months
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treatment phase
The choice of when to begin a treatment is a sensitive one for patients, and
helpful information prior to your recommendation can be gathered through a few
quick yes/no questions.
If the answers tend to be positive, the likelihood is high that candidates will be suited
to a Belotero® Hydro regimen.
®
Predictable results with Belotero® Hydro*
Before After
Before After
Before After
®
* Courtesy of Dr Lampignani
SOFT
Optimal
skin
integration
Belotero Soft
®
Belotero® Soft* smoothens fine lines away
Belotero® Soft is optimal for fine line correction and deep rehydration
due to its excellent cohesivity and its water binding capacity.9
Superficial
injection for fine
line correction
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Safe injections close to the surface without Tyndall effect10
Crow's feet
Before After
Perioral lines
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Before After
®
* Courtesy of Dres Imhof/Kühne
BALANCE
Optimal
skin
integration
Belotero
®
Balance
Belotero® Balance* becomes a part of your patients due to
its seamless integration
Cohesivity
Elasticity Belotero® Balance
Plasticity
Belotero® is seen to occupy the full thickness of the reticular dermis and is evenly distributed11
No dermal trauma or structural alteration11
D8
D114
In contrast Restylane® and Juvéderm® showed a higher degree of echoes, opaqueness, and
production of a cone of shadow underneath the injected papules.
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Belotero® has no significant local inflammatory reaction14
Belotero® showed an absence of an inflammatory reaction following injection intradermally.14
LY, PZ
and EG FM
LY, PZ and EG
E
FM
13
Micheels P et al., Dermatol Surg 2012;38:1162–1169 ®
Pictures: Courtesy to Dr Micheels and Dr Besse
14
Taufig A.Z. et al., J Ästhet Chir 2009 2:29 – 36.
Ideal for blanching
Belotero® is the only commercially available HA filler that can be administered with the
blanching technique in the superficial dermis15
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“Belotero is suitable for very superficial intradermal injection using the blanching
®
15
icheels P. et al. A Blanching Technique for
M
Intradermal Injection of the Hyaluronic Acid ®
Belotero. Plastic and Reconstructive Surgery.
2013; October Supplement.
Belotero® Balance offers smooth support of the
superficial and mid dermis
Restylane®
*Evenness was measured by
the mean residual depth of the
nasolabial target area relative to
the skin surface post treatment.
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Two-dimensional surface profiles before and 4 weeks after treatment
100
0
-100
-200
-300
0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 0.80 0.90 1.00
length (mm)
16
rager W, Steinkraus V. A prospective, rater-blind,
P
randomized comparison of the effectiveness and
tolerability of Belotero Basic versus Restylane ®
for correction of nasolabial folds. Eur J Dermatol
2010; 20 (6): 748-52.
Belotero® Balance – Tried and tested
In a long-term open-label extension study for correction of nasolabial folds, Belotero® was
well tolerated when repeat injections were given over an 18-month follow-up period.
Injection site bruising was the only adverse event that was considered to be related to Belotero®.
A clinical study in 114 patients with nasolabial folds demonstrated that 81 % of patients
were treated successfully for 24 weeks with the effect persisting for 36 weeks in 66% of the
patients.
There was good or very good tolerability in 109 out of the 114 patients.
98% of all patients and 90% of the examiners rated the treatment success as good
or very good.
17
Reinmüller J et al, Dermatol News 2007; issue 11: 2-3.
18
Taufig AZ, et al, J Ästhetische Chirurgie 2009; 2: 29-36.
19
Prager W et al, Dermatol Surg 2012;38:1143–1150.
20
Micheels P, J of cosm surg & med, VOL 4, No. 3 2009.
21
Downie JP et al, Plast Reconstr Surg, 132; 41S; Oct,
Suppl 2013.
22
Narins RS et al, Dermatol Surg, 2010;36:730-740. ®
23
Narins RS et al, Dermatol Surg, 2010; 36:1800-1808.
24
Kühne U et al, J Drugs Dermatol 2012;11:1032–1035.
Predictable results with Belotero® Balance*
Nasolabial wrinkle
Before After
Glabella wrinkle
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Before After
Nasolabial wrinkle
Before After
®
* Courtesy of Dres Imhof/Kühne
Predictable results with Belotero® Balance
Nasolabial wrinkle *1
Before After
Courtesy: Dr J Reinmüller,
Courtesy: Dr
Germany
J Reinmüller, Germa
Nasolabial wrinkle *2
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Before After
Courtesy: Fiona &Courtesy:
Marie Aesthetics
Fiona & Marie
Ltd, UK
Aesthetics
Courtesy: Dr J Reinmüller,
Courtesy: Dr
Germany
J Reinmüller, Germa
®
*1 Courtesy of Dr Reinmüller
*2 Courtesy of Merz Pharma UK Ltd.
Belotero
®
Intense
Optimal
Tissue
INTENSE
Support
Belotero® Intense* offers effective filling capacity and
natural looking results due to balanced elasticity
Finding the right elasticity to suit your patients’ needs and expectations is a matter of
balance in order to provide optimal skin support.
Cohesivity
Elasticity
Belotero® Intense
Plasticity
Belotero® Intense provides optimal filling capacity for predictable, natural looking results
whilst maintaining excellent tissue integration to minimise lumps and bumps.
®
* Belotero® Intense is equivalent to Fortélis® Extra,
a registered trademark by Anteis S.A.
Efficacy was demonstrated in a study of 149 patients to
assess the efficacy and safety of Belotero® Intense25
Mean WSRS improved significantly by 1.9 score points without any decline throughout the
12-week period.
4.5
3.98 *p < 0.001
4
3.5
3
Mean WSRS Score
2.5 2.28 *
2.04 * 2.07 *
2
1.5
0.5
0
Baseline Immediately 2 weeks 12 weeks
Post-Injection
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89.9 % of patients achieved improvement on the Investigator assessed Global Aesthetic
Improvement Scale immediately after injection. The aesthetic effect was well maintained
throughout the 3-month evaluation period.
70
59.7 59.7 57.0
60
50
40 Very much/
33.6 33.6
Patients (%)
Adverse events were localised to the injection area and occurred in 85.9 % of patients
immediately after injection and declined to 12.8 % in week 2. None were serious.
25
avicic T. Efficacy and Tolerability of a New Monophasic,
P
Double-Crosslinked Hyaluronic Acid Filler for Correction of ®
Deep Lines and Wrinkles. Journal of Drugs in Dermatology.
2011. 10(2); 134-139.
Belotero® Intense provides lasting results and high
patient satisfaction without producing lumps26
Lasting results
All subjects showed significant improvements with both fillers up to day 365.
Patient satisfaction
At week 24, improvement of patient satisfaction was significantly greater with Belotero®
Intense, p < 0.001; NASHA, p = 0.006).
24 and 48 weeks after initial injection, significantly more subjects treated with Belotero®
Intense judged themselves as satisfied compared with NASHA (24 weeks: p = 0.002;
48 weeks: p = 0.005).
-5 Belotero® Intense
-10
-15
-20 -17
-22 -21
-25
-30
-31
-35
-36
-40
* WRS = wrinkle severity rating scale
-50
-49
After 48 weeks patient satisfaction with Belotero® Intense was significantly greater than at
baseline but satisfaction on the NASHA had returned to baseline value.
Subject questionnaire confirmed that 80% of subjects treated with Belotero® Intense
and 65% of subjects injected with NASHA filler stated that their expectations were met
and that they would repeat the treatment course.
“These results may be due to the unique structure of Belotero Intense which allows
®
it to spread more regularly and fill the dermal volume defect more evenly than the
biphasic product.”
26
untrock H, Reuther T, Prager W, Kerscher M. Efficacy,
B
safety, and patient satisfaction of a monophasic cohesive
polydensified matrix versus a biphasic nonanimal ®
stabilized hyaluronic acid filler after single injection in
nasolabial folds. Dermatol Surg. 2013; 39(7):1097-105.
Minimal risk of local inflammatory reaction
with Belotero® Intense compared to others27
A study to assess the safety criteria of aesthetic filler materials by investigating intradermal
reactions after implantation of 0.2 ml dermal filler in mapped abdominal skin areas showed
no abnormality and no significant local inflammatory reaction after Belotero® injection.
No findings
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■ No histomorphological inflammation reaction ■ Light to moderate chronic inflammation
■ Even distribution of injection material ■ Increased lymphocytes, plasma cells, and
eosinophil granulocytes
■ Irregular distribution of injection material
L, P and EG
L and P
L and P
27
aufig A, et al., A new strategy to detect intrader-
T ®
mal reactions after injection of resorbable dermal
fillers. J Ästhetische Chirurgie 2009; 2: 29-36.
Predictable results with Belotero® Intense*
Lip augmentation
Before After
Before After
Before After
®
* Courtesy of Dr Micheels
Optimal
Modelling
capacity
VOLUME
Belotero
®
Volume
Belotero® Volume* models and restores facial volumes
due to its tailored plasticity
Cohesivity
Elasticity
Plasticity
Belotero® Volume
Although there was a slight increase in FVLS over time, the effectiveness of Belotero®
Volume was still significant at month 12 and month 18.
Clear visibility of
underlying musculature 5.0
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grades 3 & 5 4.0
Intermediate between
grades 1 & 2 2.0 * *
* *
* *
No visibility of *
underlying musculature 1.0
Visits
At month 12 and month 18, the mean Global Aesthetic Improvement Scale score is still
“Much improved”, supporting the FVLS results.
13 patients experienced at least one injection site reaction during the evaluation. Main site
reactions were redness and pain of mild intensity which disappeared before the next follow-
up visit.
Most patients [93 % (n=28) at month 12 and 90 % (n=18) at month 18] were satisfied with
their results and were intending to repeat the treatment and recommend it to their friends.
®
* SCR=screening visit, corresponds to D1 before injection
30
Data on file. Clinical Evaluation Report. Section VI
Predictable results with Belotero® Volume*
Cheekbones
Before After
Cheekbones
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Before After
Temples
Before After
®
* Courtesy of Dr Vandeputte
PORTFOLIO
The Belotero® family – It's a part of you
HA Needle
Belotero® product Indications Injection site and angle
concentration size
intense Correction of deeper lines, 25.5 mg/1ml 27 G Mid and deep dermis
e.g.: severe nasolabial fold, Approx 30°
lip volume, oral commissures,
marionette folds
®
NEW
Belotero® Lidocaine