Weidmann_subbed.qxp 27/5/09 3:22 pm Page 68
Aesthetic Dermatology Fillers
Figure 8: Good Safety Profile of Varioderm Subdermal filler from the injected area. Varioderm Subdermal fulfils our
expectations from the injectability (26G needle and very easy to
inject). Permanent fillers, in particular acrylates, are increasingly being
37%
7% 0% viewed critically by leading users because of the risk of granulomas.
Reactions: Therefore, the development of this hyaluronic acid with long-lasting
No reactions effects and a good safety profile plays an important role in the field of
Light fillers. According to the specifications mentioned above, hyaluronic
Medium
acids are deemed to be very safe. Short-term skin nodules and
Strong
hardening generally appear to be due to the injection techniques
56%
used and the product volume injected; a histology study
demonstrated the absence of granuloma. Foreign-body reactions with
long-term nodules may rarely occur when hyaluronic acid fillers are
applied. Treatment of such nodules can be performed by intra-nodal
Clinical Experience injection of hyaluronidase.
16
There is no need to use corticosteroids,
Varioderm Subdermal was used between April 2006 and which are associated with the risk of atrophy.
December 2008. In total 39 patients were treated with different
indications (see Figure 3). The product that was used consisted of
27mg/ml cross-linked Varioderm Subdermal, which is the highest
The immunological compatibility
concentration of dermal filler available currently on the worldwide
filler market.
of the cross-linked acid has been
demonstrated mainly by the fact that
Varioderm Subdermal was injected in subcutaneous tissue and the
deep dermis using a 26G needle. Subcutaneous injections of
the glycosaminoglycan chains contained
Varioderm Subdermal were mostly used for the treatment of deep
within its basic structure remain
naso-labial and marionette folds, cheeks and cheekbones. The
injection pressure was acceptable, and acute reactions such as
unchanged after chemical modification.
swelling, reddening and pain were either minimal or did not occur.
A pronounced volume effect and good adaptation to the tissue
were observed, so that even very pronounced folds could be Overall, Varioderm Subdermal is a new hyaluronic acid that has been
corrected. No complications were noticed either in the short term tested and has shown a good volume effect, good adaptation to the
or during check-ups after three, six, nine and 12 months, with tissue and long-lasting augmentation (see Figures 5–7). This suggests
treatment effects lasting for 12–18 months (see Figure 4). that an effect lasting for more than 12–18 months can be achieved in
some cases with a good safety profile (see Figure 8). The new
Conclusion manufacturing process for Varioderm Subdermal is interesting, allowing
With over 70 preparations available, the market for hyaluronic acids is an extremely high degree of cross-linking. Suspension in a non-cross-
cluttered; for the individual user, it can be quite difficult to linked hyaluronic acid solution is not necessary, as injection is
comprehend. Frequently, it is difficult for doctors to find out whether performed with an acceptable needle pressure.
a ‘new’ hyaluronic acid has really been produced by means of a new
production technique or whether the name or the firm has simply In our view, the duration of effective treatment has been disappointing
been changed. Only two other hyaluronic acid fillers (besides with previous preparations for subcutaneous indications, and the
Varioderm Subdermal) are useful for deep folds and subdermal material was somewhat difficult to inject and tended to start slipping.
volume augmentation, but they are much more difficult and traumatic The new product, Varioderm Subdermal, showed significant
to implant (with 16G needles) as local anaesthesia and small incision advantages in this respect. For further qualitative evaluation, more
is needed. A further problem is the dislocation and migration of the studies using neutral methods of measurement are needed.
14
■
1. Nils W, Judson B, Endre A, et al., Hyaluronic acid in and use. Patent number: DK466300T, Data supplied from versus Zyplast for the correction of nasolabial folds. Z,
synovial fluid. VI. Effect of intra-articular injection of the esp@cenet database – Worldwide, 1998. Dermatol Surg, 2003;29:588–95.
hyaluronic acid on the clinical symptoms of arthritis in 7. Balazs EA, Leshchiner A, Insolubilized biocompatible 12. Council of Europe European (COE) – European Directorate
track horses, Acta Vet Scand, 197;11:139–55. hyaluronic acid preparations. Patent number: IT1178588, for the Quality of Medicines (EDQM), European
2. Nobuhiko Y, Teruo O, Yasuhisa S, Inflammation responsive Data supplied from the esp@cenet database – Worldwide, Pharmacopoeia, 6th edition, Sodium Hyaluronate monograph,
degradation of crosslinked hyaluronic acid gels, 1987. 2008;1472.
J Controlled Release, 1992;20:105–16. 8. Balazs EA, Leshchiner A, Cross-linked gels of hyaluronic 13. Larsen NE, et al., Hylan gel biomaterials dermal and
3. Nobuhiko Y, Jun N, Teruo O, Yasuhisa S, Regulated release acid and products containing such gels. Patent immunologic compatibility, J Biomedical Materials Research,
of drug microspheres from responsive degradable number: US4636524, Data supplied from the esp@cenet 1993;1129–34.
matrices of crosslinked hyaluronic acid gels, J Controlled database – Worldwide, 1987. 14. Alsoufi A, Innovative Entwicklungen bei der Herstellung
Release, 1993;25:133–43. 9. ASTM Designation: F 2147 - 03. Standard Guide for von Hyaluronsäureprodukten, Plastische Chirurgie, 2008;
4. Jason R, Lupton TS, Allister R, Cutaneous Hypersensitivity Characterization and Testing of Hyaluronan as Starting 211–16.
Reaction to Injectable Hyaluronic Acid, Gel Dermatol Surg, Materials Intended for Use in Biomedical and Tissue 15. Meyer U, Grümmer B, Biological evaluation of Varioderm
2000;22:135–7. Engineered Medical Product Applications. Subdermal according to DIN EN ISO 10993, Bioserv
5. Duranti F, Salti G, Bovani B, et al., Injectable Hyaluronic 10. Cheng, et al., Collagen and injectable FillersZ, Laboratories GmbH Rostock, 2009;2.
Acid Gel for Soft Tissue Augmentation. A clinical and Otolaryngologic clinics of North America, Heft, 2002;35: 16. Soparkar CN, Patrinely JR, Managing inflammatory
Histological Study, Dermatol Surg, 1998;24(12):1317–25. 73–85. reaction to restylane, Ophtal Plast Reconstr Surg, 2005;21(2):
6. Leshchiner A, Leshchiner E, Balazs EA, Larsen NE, 11. Rhoda S, et al., A randomized, double-blind, multicenter 151–3.
Biocompatible viscoelastic gel slurries, their preparation comparison of the efficacy and tolerability of Restylane
68 EUROPEAN DERMATOLOGY
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