A novel dermal filler with lidocaine and its applicationMichael Weidmann1
1Dermatologist, Klinik am Forsterpark Augsburg, Germany
Methods and materials –
how and what was performed
Background – a brief discussion of the subject
Patients, 18 to 80 years old, were treated and
Hyaluronic acid (HA) is a polysaccharide (glycosamino-
followed up after one week, one, three, six and nine
glycan) present throughout the body. As an extraordi-
months for adverse events and estimation of filler
nary viscoelastic and biocompatible molecule, it has
found an extensive use as a non-permanent dermal
Conclusion – outcome of the work
Objective – the purpose of the work described
New generation HA fillers with lidocaine showed:
(1) excellent physical properties, (2) low adverse
Goal of this study was to investigate and classify
events rate (the only severe AE was swelling in two
adverse events after use of a new generation of
patients, while light and moderate pain during and
dermal filler with lidocaine. Physical properties, perfor-
pain after procedure were noted in eight patients from
mance and safety of these fillers were investigated in
sixty-eight treated); (3) patients satisfaction with filler
patients seeking medical and cosmetic corrections in
effects lasted at least six to nine months after the
the face area in a short and long-term period.
procedure during follow-up, without touch-ups.
6 MÄC Magazin für ästhetische Chirurgie 4 15 10. Jahrgang 2015
Hyaluronic acid (HA) is a polysaccharide (glycosaminoglycan)
determines stiffness of gel, resistance of gel to deformation
present throughout the body: in the skin, connective tissues,
and that filler remains at the site of injection. Viscosity is shown
synovial fluid and others . Under physiological pH conditions
as viscous modulus (G´´) measured in Pa. Elasticity of the gel is
HA occurs as a salt, referred to as hyaluronate or hyaluron.
a feature that determines the ability of the fluid to return to its
Many properties make HA beneficial for use as dermal fillers,
original shape and to withstand changes from external mecha-
among others an ability to bind large amounts of water and a
nical forces. Elasticity is shown as elastic modulus (G´) and
low potential for allergic reactions. Commercial production of
measured as well in Pa [5, 6].
HA in a high scale has been achieved via microbial fermenta-
tion by Streptoccocus zoodermicus
or Bacillus subtilis
Several properties of HA gels are important for their application
found an application in medical and cosmetic industry .
as dermal fillers, such as: (1) HA concentration, (2) cross-
linking degree, (3) gel visco-elasticity (hardness) and (4) ease
HA is an extraordinary viscoelastic molecule that can bind
proteins due to its polyelectrolyte properties, thus enabling
the foundation for the mechanically strong three dimensional
Methods and Materials
networks formed between the cells and collagen fibrils .
HA is the biomaterial from which non-permanent dermal fillers
HA gels containing 0.3% lidocaine and with concentrations of
12, 16, 20 and 24 mg/ml (Hyabell®, Adoderm GmbH,
Germany) were injected into different skin layers (mid dermis,
HA-fillers are class III medical devices, consisting of intrader-
deep dermis and subcutis etc. according to the manufacturer´s
mal injectable hyaluron gels applied as dermal fillers. They may
use instructions) using 27G needle and/or 22G cannula.
contain substances such as local anesthetics to relieve patient
from discomfort or pain or/and other physiologically active
substances (antioxidants, vitamins etc.) to enhance the rejuve-
nation potential of skin.
Patients eligible to participate in the study were from 18 to 80
years old and showed no skin pathology or risk factors for skin
The physical and rheological properties of dermal fillers affect
pathology, seeking cosmetic corrections of medium-sized
the clinical performance. These properties can be altered and
depressions of the facial skin received treatments of wrinkles
appear to correlate with the total concentration and elasticity of
and volume enhancement. Prior to treatment they signed a
Injectable HA dermal fillers show different visco-elastic proper-
ties , injectability and durability after injection into skin .
The higher cross-linked HA is better protected from the fast
68 patients were treated for different indications with 0,5 to
enzymatic degradation by hyaluronidases, enzymes present in
3 ml of HA gels using linear retrotracing, and/or criss-cross
the intracellular space, and/or free radicals . Further, elasti-
technique or fan-technique or by a combination of these tech-
city and viscosity are important rheological parameters, as HA
niques, without any touch-ups. All treatments were performed
gels fill the cavities in three-dimensional space enabling the
without anesthesia. After the treatment follow-up was done for
new tissue positioning. Viscosity of the gel is a feature that
the level of adverse events (light, medium and severe; pain
MÄC Magazin für ästhetische Chirurgie 4 15 9. Jahrgang 2015 7
Figure 1: Representative photographs of patients before (l.) and after (r.) Hyabell® gel injections. Injection in the
cheek area produced significant face uplift with 1 ml used per side and injections in lips enhanced volume with
0.7 ml gel per lip.
during injection, pain after injection, redness, swelling, itching,
bruising, discoloration, hematoma, and other), as well as satis-
faction and efficacy of the product estimated by patients and
Figure 1 shows example photos of patients before and after
practitioners, respectively during the period of nine months
treatment for lips (0,7 ml/lip) and cheeks (1 ml/side) indications,
after the treatment.
The distribution of adverse events among 68 patients is shown
in figure 2. Swelling was reported in 13 cases (19,12%) as
The assessment was based on following criteria: (1) patients
light, in four cases (5,88 %) as medium and in two cases
comfort during and after treatment, (2) any immediate and/or
(2,94%) as severe and it was the only type of severe AE.
delayed side effects and their intensity (light, medium, severe),
Redness was noted in eight cases (11,76 %) as light and in
(3) the aesthetic satisfaction. All adverse events (AEs) were
one case (1,47%) as medium level. Pain after injection was
recorded and their severity was classified from 1 and 2 –
present in one case (1,47%) as medium level and in two cases
light, (duration less than 3 days, no treatment necessary), 3 –
(2,94%) as light. Pain during injection and bruising showed
medium (duration less than 7 days, complete resolution with or
light level in five cases (7,35%), and light itching and hema-
without treatment) and 4, 5 – strong/severe (duration longer
toma in one case (1,47%). There were not any cases of dis-
than 7 days or complete resolution with treatment). Both
coloration, allergic reactions to hyaluronic acid or lidocaine or
patients and doctor noted the aesthetic improvement using the
any other types of AE. In the follow-up of the patients during
scale: 0 – worse (depression is deeper), 1– poor (no change,
nine months not any type of delayed AE was noted.
the patient is not satisfied), 2 – satisfactory (somewhat impro-
ved, acceptable, but a touch-up is necessary), 3 – good
The most common indications among treated patients were
(moderately improved, acceptable even without touch-up), 4 –
enhancement and contouring of lips (25%), filling of bitterness
excellent (expectation is matched, no touch up is necessary).
lines (23%) and nasogenian folds (28%) (figure 3). Injectability
Pain presence was described as 0 (no pain) to 1(present pain).
of HA was noted by the practitioner as easy in most patients
and acceptable in only one patient.
8 MÄC Magazin für ästhetische Chirurgie 4 15 9. Jahrgang 2015
Figure 2: Distribution of adverse events (AE) among 68
Figure 3: The most common indications among treated
patients after dermal injections.
patients were nasogenian folds (28%), lips (25%) and
The majority of patients did not have any AE. The most
bitterness lines (23%).
common AE were swelling and redness.
Figure 4: Extrusion force and injection curves profiles of
Figure 5: Viscoelastic properties of hyaluronan gels were
dermal fillers through a thin needle.
measured on the shear rheometer and compared.
The extrusion force of preﬁlled syringes was measured with
Hyabell® (HB) gels showed a wide range of viscous (G´´)
a Zwick/Roell Z005, F
200N testing device (from Zwick
and elastic modulus (G´) from 712 Pa to 9 Pa and 270 Pa
Roell AG, Ulm, Germany). The measurements were performed
to 15 Pa, respectively. Measurements were done using
with one type of 27G needle (TSK Laboratory, Japan). The
patterns and extrusion forces differ among gels.
MÄC Magazin für ästhetische Chirurgie 4 15 9. Jahrgang 2015 9
One month after treatment 57,35% patients judged the treat-
suitable for the use in hypodermis and deep dermis, while gels
ment as excellent, 27,94% as good and 14,71% as satisfying.
with lower viscosity and elasticity are more suitable for use in
After three and six months the majority of patients were still
satisfied with the results, but after nine months this was only
the case with Deep and Ultra products. There were not any
cases of longtime complications or worsening of previous con-
ditions. Practitioners judged the efficacy of the fillers as well
and their results showed the same trend in efficacy and dura-
Extrusion force of Hyabell® was lower and more constant in
comparison to other gels, as shown in figure 4. The Hyabell®
gels have as well a high viscosity and elasticity, presented as
Volpi N, Schiller J, Stern R, Soltés L.
Role, metabolism, chemical modifica-
elastic modulus (G´) and viscous modulus (G´´) in figure 5.
tions and applications of hyaluronan.
Curr Med Chem. 2009;16(14):1718-
Liu L, Liu Y, Li J, Du G, Chen J.
Treatment of patients with new generation of dermal fillers with
Microbial production of hyaluronic
acid: current state, challenges, and
0,3% lidocaine, Hyabell®, showed very good results with low
perspectives. Microb Cell Fact.
gel amounts. There was a low rate of adverse events and not
any long-term complications reported during the 9 months
Falcone SJ, Berg RA. Crosslinked
follow-up. Majority of patients stayed very satisfied with the
hyaluronic acid dermal fillers: a com-
achieved results for at least six months after injections. Lido-
parison of rheological properties. J
caine content in HA gels may have enhanced patient comfort
Biomed Mater Res A. 2008;87(1):264-
during and after procedure.
Stocks D, Sundaram H, Michaels J,
Properties such as injectability through a thin needle into soft
Durrani MJ, Wortzman MS, Nelson
DB. Rheological evaluation of the
tissue, homogenous patterns and lower extrusion force could
physical properties of hyaluronic acid
correspond to less hematoma and bruising adverse events
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after use of Hyabell® gels. This property may enable a better
manipulation of the needle and/or cannula in the dermis due to
Tezel A, Fredrickson GH. The science
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It is beneficial for a physician to know about these specificati-
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ons, especially G´ and G´´ modulus prior to use. A wide range
Gershkovich J. Comparative physical
properties of hyaluronic acid dermal
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layers – gels with high viscosity and elasticity could be more
10 MÄC Magazin für ästhetische Chirurgie 4 15 9. Jahrgang 2015
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