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M. Weidmann
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 [1]. 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 and has Several properties of HA gels are important for their application found an application in medical and cosmetic industry [2]. 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 of injectability. 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 [1]. 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- Study Design
ties [4], injectability and durability after injection into skin [5].
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 [5]. 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 SAOS rheometer.
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 middle dermis.
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 dermal fillers. J Drugs Dermatol.
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 less applied force. of hyaluronic acid dermal fillers. J Cosmet Laser Ther. 2008;10(1):35-42.
It is beneficial for a physician to know about these specificati- Kablik J, Monheit GD, Yu L, Chang G, ons, especially G´ and G´´ modulus prior to use. A wide range Gershkovich J. Comparative physical properties of hyaluronic acid dermal of viscoelastic properties enables the treatment of different skin fillers. Dermatol Surg. 2009;35 Suppl 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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