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Update on Botulinum Toxin and Dermal Fillers Berbos and Lipham 389 Update on botulinum toxin and dermal fillers Zachary J. Berbosa and William J. Liphama,b aDepartment of Ophthalmology, University of Purpose of review Minnesota and bMinnesota Eye Consultants, Minneapolis, Minnesota, USA The art and science of facial rejuvenation is an ever-evolving field of medicine, as evidenced by the continual development of new surgical and nonsurgical treatment Correspondence to William J. Lipham, MD, Minnesota Eye Consultants, PA, 9801 Dupont Avenue South, modalities. Over the past 10 years, the use of botulinum toxin and dermal fillers for Suite #200, Bloomington, MN 55416, USA aesthetic purposes has risen sharply. Herein, we discuss properties of several Tel: +1 952 567 6079; e-mail: [email protected] commonly used injectable products and provide basic instruction for their use toward the goal of achieving facial rejuvenation. Current Opinion in Ophthalmology 2010, Recent findings 21:387–395 The demand for nonsurgical injection-based facial rejuvenation products has risen enormously in recent years. Used independently or concurrently, botulinum toxin and dermal filler agents offer an affordable, minimally invasive approach to facial rejuvenation. Summary Botulinum toxin and dermal fillers can be used to diminish facial rhytides, restore facial volume, and sculpt facial contours, thereby achieving an aesthetically pleasing, youthful facial appearance. Keywords botulinum toxin, dermal fillers, facial rejuvenation Curr Opin Ophthalmol 21:387–395 ß 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins 1040-8738 was approved for treatment of cervical dystonia under Introduction the trade name Myobloc (Elan Pharmaceuticals, Dublin, Facial rejuvenation involves a spectrum of interventions, Ireland). Since its initial FDA approval, the scope of ranging from topical cosmetic products to surgical tissue botulinum toxin has expanded to include treatment of manipulation. Botulinum toxin and dermal filler injec- a variety of spastic disorders, pain syndromes, hyperse- tions fall somewhere in the middle of this spectrum. cretory conditions, and aesthetic concerns [2,3]. Botuli- Used alone or in conjunction with other modalities, num toxin is currently FDA approved for treatment of botulinum toxin and dermal filler products play an over 20 conditions, and is commonly used ‘off-label’ for important role in achieving a youthful, aesthetically many more worldwide [2] (Table 1). pleasing facial appearance. Origin, structure, and mechanism Background Botulinum toxin is an exotoxin produced by the Gram- Produced in nature by the Gram-positive rod Clostridium positive rod, C. botulinum. The toxin is a disulfide-linked botulinum, botulinum toxin is nature’s most potent exo- 50 kDa light chain/100 kDa heavy chain complex, bound toxin. Through research efforts over the past 30 years, to a variety of nontoxin stabilizing proteins [4]. Seven medicine has harnessed the powerful toxin for use in a distinct toxin serotypes (A–G) exist in nature, each variety of therapeutic and aesthetic settings. Therapeutic produced by a different strain of C. botulinum [5]. Types potential was first recognized in the 1970s when Scott [1] A and B are commercially produced as they possess used botulinum toxin to treat strabismus in monkeys. properties making them most clinically advantageous Scott, thereafter, produced botulinum toxin type A com- [6]. The toxin functions by inhibiting acetylcholine mercially under the trade name ‘Oculinum’ (Allergan, release at the neuromuscular junction, resulting in flaccid Inc., Irvine, California, USA), which gained the US Food paralysis of targeted muscles. Toxin serotypes A and B and Drug Administration (FDA) approval in 1989 for differ in their binding site and target molecules in the treatment of dystonias [1]. Allergan purchased the rights presynaptic nerve terminal [7,8]. These small differences to produce botulinum toxin-A (BTX-A) in 1991, and are clinically relevant, allowing alternative toxins to be changed the name to the familiar moniker ‘BOTOX’ employed in the event of treatment failure with a particular (Allergan, Inc.). In 2000, botulinum toxin-B (BTX-B) agent [9]. 1040-8738 ß 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI:10.1097/ICU.0b013e32833ce7bc Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. 388 Oculoplastic and orbital surgery Table 1 FDA-approved indications for botulinum toxin Some studies [4,22–26] report an increased side-effect Formulation FDA-approved uses profile, and greater diffusion of Dysport into unintended areas using conversion factors ranging from 4 to 5 : 1. BOTOX Upper limb spasticity Cervical dystonia Studies using lower doses of Dysport have reported Primary axillary hyperhydrosis decreased duration of clinical effect and reduced patient Facial dystonias and strabismus satisfaction [23]. Adding to the confusion, these studies Glabellar rhytides Dysport Cervical dystonia attempt to extrapolate relative potency data from various Glabellar rhytides dystonia studies to cosmetic use. Recent literature Myobloc Cervical dystonia regarding the use of Dysport for cosmetic purposes suggests that use of a 2.5–3.0 : 1-conversion factor results in comparable outcomes with regard to clinical efficacy and side-effect profile, with a trend toward slightly decreased longevity of paralysis versus BOTOX Available formulations of botulinum toxin type A [16 ,27–30]. With a rapidly growing body of literature regarding cosmetic use of Dysport, reliable data regard- There are currently three available formulations of botu- ing dosing parameters should be available in the linum toxin type A, two of which are approved for use in near future. the United States. Xeomin (150 kDa) BOTOX (900 kDa) Xeomin is an uncomplexed BTX-A approved for use in Approved for use in dystonias in 1989 and BOTOX spastic disorders and for cosmetic purposes in Europe, Cosmetic for cosmetic use in 2002, BOTOX is the most Mexico, and Argentina, and is in phase 3 trials for use in well studied of the type A botulinum toxins. BOTOX is glabellar rhytides in North America [31,32]. Studies distributed as a vacuum-dried powder that requires [33,34] comparing Xeomin to BOTOX demonstrate a reconstitution with 0.9% (or physiologic) normal saline. 1 : 1 relative potency, comparable clinical efficacy, and Allergan packaging recommends reconstitution with similar side-effect profile. Potential benefits of Xeomin nonpreserved saline, requiring use within 4 h. However, include reduced immunogenicity given the lack of com- several studies have demonstrated no reduction in plexing proteins, and ease of storage, as the solution is clinical efficacy [10,11], duration of action [11,12], or stable unrefrigerated up to 4 years [31,35]. degree of paralysis measured electrophysiologically [13], when reconstituted with preserved saline and Dilution refrigerated up to 2 weeks. In practice, many clinicians Dilutions reported in the BOTOX literature range from use preserved saline and refrigerate BOTOX for use up to 10 to 100 U/ml, all of which demonstrate similar clinical 7–10 days after reconstitution [14]. Concerns regarding efficacy and duration of effect [6,36]. Of note, higher bacterial contamination with prolonged storage have concentrations (lower volumes) allow more precise deliv- been quelled by studies showing safety well beyond ery to smaller muscle groups, have less tendency 2 weeks [11,15]. toward diffusion to unintended areas, and distort local architecture to a lesser extent, resulting in less painful Dysport (500/900 kDa) administration [6,37]. Most practitioners, however, use Approved for cosmetic use in the USA in April 2009, 40–50 U/ml for facial rejuvenation purposes. Dysport (Allergan, Inc.) has been used in over 65 countries worldwide since 1991 [16 ]. Dysport is a type Dosing A botulinum toxin that differs from BOTOX in purifi- Dosage must be individualized based on muscle mass of cation methodology. It is distributed as a lyophilized the treatment area. For this reason, women generally powder requiring reconstitution with nonpreserved saline require fewer units in a given treatment area versus and use within 8 h of reconstitution as per packaging men [38]. While variability exists regarding starting dose, recommendations. As with BOTOX, studies [10,17] there is a trend toward using fewer units of BOTOX as have shown safety and efficacy when used beyond 2 patients and practitioners attempt to avoid a ‘frozen’ weeks after reconstitution with preserved saline. appearance and minimize complications. General guide- lines for treatment doses as well as injection patterns for Reports in the literature vary widely regarding relative commonly treated areas are as follows: efficacy, duration of effect, and side-effect profile of Dysport versus BOTOX. The confusion stems from (1) Glabella: 15–30 units divided (women), 20–40 units variability in dosing, dilution, and muscles treated among divided (men) (Fig. 1); studies. Dosing conversion factors from 1.5 to 6.0 : 1 (2) Horizontal forehead rhytides: 10–20 units (women), (Dysport : BOTOX) have been reported [18,19–21]. 1500–25 units (men) (Fig. 2a and b); Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited. Update on botulinum toxin and dermal fillers Berbos and Lipham 389 Figure 1 Reduction of glabellar furrows instances of resistance/nonresponse (or treatment failure with) to BTX-A [44]. Dermal fillers Volume enhancement utilizing autologous fat dates back well over a century. Introduction
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