Clinical Use of Restylane

J. S. Dover, MD, FRCPC; A. Carruthers, MD, FRCPC; J. Carruthers, MD, FRCSC; M. Alam, MD

Disclosures

Skin Therapy Letter. 2005;10(1):5-7. 

In This Article

Abstract and Introduction

There is no ideal filler, nor will there be a single product that can satisfy all requirements. However, RESTYLANE ®, a non-animal, stabilized hyaluronic acid (NASHA, Medicis), is a very versatile augmenting agent. It has been in clinical use for 8 years and experience has shown it to be close to the ideal filler in many respects. This review will outline the background to the use of RESTYLANE ®, and will focus on the clinical use of this material.

The pace of development of filler substances in the last few years has been phenomenal. Consider that for more than 20 years there was only one US FDA approved cutaneous filler device, bovine collagen (Zyderm®/Zyplast®, Inamed Aesthetics). Bovine collagen has several distinct disadvantages. Two skin tests are necessary, producing a minimum 4-to 6-week treatment delay between the initial consultation and the first treatment. Results are short lived, and the thickest collagen, Zyplast®, lasts only 2-4 months. Beading is relatively common because the product becomes firm and nonmalleable soon after injection.

In February 2003, human collagen (Cosmoderm™/ Cosmoplast, Inamed Aesthetics) was approved by the US FDA. In December 2003, the US FDA approved RESTYLANE®, a cross linked nonanimal source hyaluronic acid. Two other forms of cross-linked hyaluronic acid, Hylaform® and Hylaform® Plus (Inamed Aesthetics) were approved by the US FDA in the summer and fall of 2004, respectively. RESTYLANE® is made by Streptococci and Hylaform® is derived from chickens' combs. They also differ in the amount and degree of cross-linking, which affects, among other things, duration of effect. Many more fillers are under development, and some are pending US FDA approval.

Considering the complexity of the areas/conditions being treated, as well as the aims and desires of the individual being treated, there is no ideal filler. Futhermore, no single product will be able to satisfy all requirements. However, a product would be useful in the majority of clinical situations with the following properties:

  • non-permanent but long-lasting

  • have minimal side-effects

  • not require allergy testing

  • be easy to use/inject

  • be cost-effective both to the physician and patient

RESTYLANE®, a non-animal, stabilized hyaluronic acid (NASHA) is not ideal, but is far closer to this set of criteria than previous fillers.

RESTYLANE® has been available in Europe since 1996, and in Canada since 1998. It is used in more than 60 countries to correct a variety of wrinkles, lines, and contour defects and to enhance the lips. It was approved in the US in December 2003, for use in mid-to-deep dermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as the nasolabial folds.

Benefits of RESTYLANE® include:

  • having a very low allergic potential so that skin tests are unnecessary

  • having a very natural look and feel

  • lasting significantly longer than any of the collagens

  • being moldable and very easy to work with

Disadvantages include temporary redness and swelling at the injection site, which is most clinically significant when the lips are injected and most often resolves within 3-4 days. Allergic reactions are rare. Most of those reported occurred prior to 2000 when the level of contaminants in the product were dramatically reduced.[1]

The best data on RESTYLANE® comes from a study of 138 subjects that led to US FDA approval.[2] This was a bilateral paired comparison study of the efficacy and safety of RESTYLANE® vs. Zyplast® use in the nasolabial folds. The products were injected at baseline, followed by touch-ups as necessary to achieve "optimal cosmetic improvement". Judging subjects' folds using a 5-point scale (none, mild, moderate, severe, extreme), both products achieved a 1.5 point improvement. At 6 months, the RESTYLANE® injected side still had a 1 point improvement, whereas the Zyplast® injected side had a 1/3 point improvement. At 6 months after injection RESTYLANE® was considered to be superior in 62% of patients vs. 8% of patients for Zyplast®.

There were more adverse events in the Zyplast®-treated side, but these were mainly minor lumpiness or material showing through the skin. Whereas on the RESTYLANE®-treated side there was more swelling and tenderness (see Table 1 ).

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....