Hot Topics Treatment of Nasolabial Folds With Fillers According to the author, injectable dermal fillers can be used effectively to treat nasolabial folds. He offers advice on evaluating the depth and classifying the type of nasolabial fold (crease, fold, or hybrid) and then selecting an appropriate filling agent. (Aesthetic Surg J 2004;24:489-493) S uccessful treatment of the nasolabial fold (NLF) has presented an ongoing challenge. In addition to traditional face lifts, other surgical treatments have included direct excision, elevation of the malar fat pad, and debulking of the inferior aspect of the malar fat pad.1-4 However, even with the use of these techniques, there are still patients who are unhappy with the appearance of their NLF after undergoing surgery. Other patients are unhappy with the appearance of their NLF but they are resistant to having surgery. The use of injectable dermal fillers to improve the NLF can offer a pleasing alternative. There are several Food and Drug Administration (FDA) approved filling agents now available, and it is anticipated that additional fillers will be approved soon.5 Each dermal filler has its own distinct characteristics with variations in qualities such as thickness, durability, reactivity, and efficacy. Understanding these characteristics will enable physicians to choose the appropriate product for each patient.5,6 Recently, there have been several excellent reviews of dermal soft tissue fillers, including an article by Dr. Bergeret-Galley.7 Here, I will explore the products that work best for different types of patients. NLF Creases vs Folds To treat the NLF it is important to identify its anatomic variations. In addition to varying degrees of NLF severity, there are 2 separate and distinct anatomic configurations: (1) nasolabial creases and (2) nasolabial folds. Nasolabial creases can be a result of repetitive muscle movement and represent actual creases in the skin that overlie the anchoring musculofascial attachments. AESTHETIC These creases, which are skin defects rather than contour deformities, appear to be epidermal and dermal, not created by overhanging skin. This type of NLF is more common in younger patients and in patients with Mark G. Rubin, MD, Beverly thin skin (Figure 1). Hills, CA, is a board-certified The second group of dermatologist. patients has an actual fold of skin in the nasolabial area. Anatomic studies have shown that the actual NLF position remains unchanged over time, but the downward migration of the malar cheek pads over the anchored base of the NLF creates the true overhang defect associated with deep NLFs.8-10 Studies have shown that a thickening of the inferior aspect of the malar cheek pad in conjunction with the descent of the overlying skin creates the true “fold” (Figure 2).9 The NLF can present problems that are not always easy to classify. Many patients exhibit hybrid characteristics of both creases and folds (Figure 3).These differences are significant because certain filling agents are better suited to each category of fold. Therefore, in the hybrid type of NLF, more than one dermal filler may be needed to achieve optimal results. Commonly, a base of thick, deep filler is injected for contour correction. Then a thinner material is injected in a more superficial layer over the first injection. Severity of NLF Problem The NLF has also been classified according to severity of the problem (Figure 4). This classification has been validated and used by the FDA in clinical trials assessing the efficacy of Restylane (Q-Med, Uppsala, Sweden).11 The use of dermal fillers in patients with mild to moderate NLFs (severity rating 2 to 4) is usually quite successful. However, using dermal fillers to treat patients with deep NLFs (severity rating 5) is usually modestly successful at best. In these patients, with significant cheek ptosis, SURGERY JOURNAL ~ September/October 2004 489 Hot Topics Figure 1. Nasolabial creases resulting from repetitive muscle movement are epidermal and dermal skin defects rather than contour deformities. Figure 3. Hybrid NLFs are a combination of a nasolabial crease and fold problem. filling the fold actually pushes the redundant skin upward, creating a more pronounced ridge at the superior aspect of the NLF. Filling Agents Classifying the depth and type of NLF is the first step in successful therapy. The second step is to select an appropriate filling agent. Consider the type of fold you are treating. Nasolabial creases (dermal and epidermal defects) require a dermal filler injected into the upper or mid dermis for best results. Attempting to fill these creas- 490 Aesthetic Surgery Journal ~ Figure 2. True nasolabial folds. es with a deep dermal or subdermal injection may improve their contour but will not fill in the superficial dermal defect. Over the years, it has been common practice to treat a patient with NLF creases with Zyplast collagen (INAMED Corp., Santa Barbara, CA). The result is good, but not great. Treating that same crease with a thinner dermal filler, such as Zyderm 1 (INAMED Corp.), placed more superficially, will give an excellent result, superior to that achieved with Zyplast. True NLFs are not skin defects; in addition to skin redundancy they represent loss of support and an apparent loss of volume. These folds are best treated with volume correction using either deep dermal or subdermal injectables. Another method may be to augment the cheek itself, which creates a lifting effect in the NLF. Certainly, in patients with deep NLFs, filling agents alone are not sufficient and work best when used as a followup to surgery. There are multiple injectable materials on the market for use in treating NLFs. These products may be divided into 4 groups: (1) permanent, (2) temporary, (3) dermal fillers, and (4) subdermal fillers. Additionally, these materials can also be subdivided into true space-occupying dermal fillers and bioactivators, which correct not only by providing temporary volume, but also by stimulating collagen deposition leading to long-term increasing correction. Products in the true space-occupying category include liquid silicone, and Artefill (Artes Medical, San Diego, CA). Sculptra (Dermik Laboratories, Aventis Pharmaceutical, Bridgewater, NJ) is considered a bioactivator. Although these products are September/October 2004 Volume 24, Number 5 Hot Topics A B C D Figure 4. Wrinkle severity scale. Three examples (horizontally) of: A, Score 2. B, Score 3. C, Score 4. D, Score 5. (Photos courtesy of Q-Med and MEDICI, manufacturer and US distributor of Restylane). promising, they are currently not approved by the FDA as facial fillers, except for Sculptra, which was approved August 3, 2004, for treatment of facial wasting in HIV patients. Recently, there has been a trend to use temporary or semipermanent fillers rather than those that are permanent. This may be attributed to a desire to avoid long-term complications that can arise from permanent materials.6 Any physician who has been confronted by a patient who is unhappy with some lumps or bumps from collagen or fat injections is grateful that the problem will self-correct Treatment of Nasolabial Folds With Fillers AESTHETIC when the material degrades. With permanent fillers, problems are permanent. Also, full permanent correction of the NLF with a dermal filler may create problems after facial surgery. When the skin is tightened and the malar fat pad repositioned, the previously injected material may be pulled closer to the surface where it may appear nodular or ropelike. This is not a problem in all patients, but certainly needs to be considered when selecting a filling agent. Currently available FDA approved materials include (1) bovine collagen (Zyderm, Zyplast, INAMED); (2) bioengineered human collagen (Cosmoderm, SURGERY JOURNAL ~ September/October 2004 491 Hot Topics Cosmoplast, INAMED); (3) nonanimal stabilized hyaluronic acid (Restylane, Q-Med, Uppsala, Sweden); (4) calcium hydroxylapatite (Radiance, Bioform Medical, Franksville, WI); (5) mycelized acellular freeze dried human fascia (Cymetra, LifeCell, Branchburg, NJ); (6) Fascian (Fascia Biosystems, Beverly Hills, CA), (7) avianderived stabilized hyaluronic acid (Hylaform, INAMED), and autologous fat. Intradermal fillers include Zyderm, Zyplast, Cosmoderm, Cosmoplast and Restylane. Subdermal fillers include autologous fat, Radiance, Fascian, and Cymetra. When selecting an appropriate injectable, the following factors should be kept in mind: safety, persistence, and the number of treatments needed for optimum correction. Homologous human fascia-derived materials (Fascian, Cymetra) produce inflammation involving several days of posttreatment swelling and erythema. Usually, more than one injection is necessary to achieve acceptable correction. Longevity of these materials has been reported as 4 to 12 months but neither product is highly popular.12,13 Autologous fat grafting has a more than 100-year clinical history, yet has still failed to yield the predictable, long lasting results desired.14 Certainly, it has a role in patients with deep NLFs who need significant volume and are willing to accept the downtime (similar to posttreatment morbidity when using human fascia-derived materials) associated with fat grafting. Both collagen-based products, bovine and human bioengineered, have similar effects. They generally create minimal inflammation with minimal posttreatment morbidity. In most cases, one treatment is sufficient for acceptable correction. The greatest limitation is the longevity of these products, which is generally 3 to 6 months.7 Although there are no published studies comparing the longevity of Cosmoderm with Zyderm, my personal experience has been that it is quite similar. Restylane has a similar postinjection adverse event profile to the collagen-based products, however, its longevity has been shown to be significantly greater—generally, 6 to 12 months. In most patients, one injection provides acceptable results.11 Radiance (calcium hydroxylapatite crystals in a gel base) is a subdermal injection product unlike collagen and hyaluronic acid gel. This material, like autologous fat, is used as a volume filler to change contour rather than to fill in a crease. Use of this product as a facial filler is fairly new, with about 2 years follow-up. Longevity 492 Aesthetic Surgery Journal ~ appears to be variable, with patients having from 30% to 100% correction after 2 years.12 Treatment Patients with nasolabial creases respond best to the intradermal injectables. The most superficial creases require the thinnest dermal filler, such as Zyderm 1 and Cosmoderm. 1 Deeper creases may be treated with Zyderm 2 or with small amounts of Restylane placed deeper in the dermis, which must be massaged to assure a smooth contour. Attempting to fill finer creases with superficial placement of a thick product will result in lumpiness and an unacceptable result. Deep dermal placement of a subdermal filler in these patients will give some degree of improvement, but will fail to adequately fill the superficial aspect of the crease. In treating true NLFs, volume is necessary; placing thicker material deeply can restore the contour needed. Superficial placement of a thin material will give minimal results with almost no longevity. (Remember that longevity is due to the inherent durability of the injectable, the patient’s metabolism, and the degree of correction achieved with the final injection). A patient who is only 50% improved with the dermal filler injection will be disappointed with the longevity of their correction much sooner than if they had achieved 80% correction with the initial injections. As treatment options for the aging face multiply, patient evaluation becomes ever more critical. By carefully considering the NLF type, as well as the patient’s expectations regarding degree of correction and longevity, you can effectively deliver an acceptable cosmetic result in most patients. ■ Note: The author conducted an FDA trial of Restylane funded by Q-Med, manufacturer of Restylane. He is also a member of the Speaker’s Bureau for Medicis, distributor of Restylane. References 1. Netcher DT. Ancillary excisions in the periorbital and nasolabial regions for facial rejuvenation revisited. Aesthetic Plast Surg 1995;19:193-196. 2. Owsley JQ. Elevation of the malar fat pad superficial to the orbicularis oculi muscle for correction of prominent nasolabial folds. Clin Plast Surg 1995;22:279-293. 3. De Cordier BC, De La Torre JI, Al-Hakeem MS. Rejuvenation of the midface by elevating the malar fat pad: Review of the techniques, cases and complications. Plast Reconstr Surg 2002;110:1526-1536. 4. Owsley JQ. Lifting the malar fat pad for correction of prominent nasolabial folds. Plast Reconstr Surg 1993;9:463-474. Discussion 475-476. September/October 2004 Volume 24, Number 5 Hot Topics 5. Rohrich R, Rios JL, Fagien S. Role of new fillers in facial rejuvenation: A cautious outlook. Plast Reconstr Surg 2003;112:1899-1902. 6. Saylan Z. Facial fillers and their complications. Aesthetic Plast Surg 2003;23:221-224. 7. Bergeret-Galley C. Comparison of resorbable soft tissue fillers. Aesthetic Plast Surg 2004;24:33-46. 8. Yousif NJ, Gosain A, Sanger JR, Larson DL, Matloub HS. The nasolabial fold: A photogrammetric analysis. Plast Reconstr Surg 1994;93:7077. 9. Gosain AK, Amarante MT, Hyde JS, Yousif NJ. A dynamic analysis of changes in the nasolabial fold using magnetic resonance imaging: implications for facial rejuvenation and facial animation surgery. Plast Reconstr Surg 1996;98:622-635. 10. Hoefflin SM. The ligamentous facial fence: The cause of nasolabial folds and jowling. Plast Reconstr Surg 1998;101:1148. 11. Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg 2003;29:588-595. Treatment of Nasolabial Folds with Fillers AESTHETIC 12. Sclafani AP, Romo T, Jacono AA .Rejuvenation of the aging lip with an injectable acellular graft (Cymetra). Arch Facial Plast Surg 2002;4:252-257. 13. Burres S. Preserved particulate Fascia Lata for Injection: A New Alternative. Dermatol Surg 1999;25:790-794. 14 Eremia S, Newman N. Long-term follow-up after autologous fat grafting: Analysis of results from 116 patients followed at least 12 months after receiving the last of a minimum of 2 treatments. Dermatolog Surg 2000;26:1150-1158. 15. Graivier M. Personal Communication. April 2004. Accepted for publication June 16, 2003. Reprint requests: Mark G. Rubin, MD, 153 S. Lasky Drive, Suite 1, Beverly Hills, CA 90212. Copyright © 2004 by The American Society for Aesthetic Plastic Surgery, Inc. 1090-820X/$30 doi:10.1016/j.asj.2004.06.004 SURGERY JOURNAL ~ September/October 2004 493
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