Leslie Baumann

Hyaluronic acid gel ( Juvéderm ™ ) preparations in the treatment of facial wrinkles and folds

Soft tissue augmentation with temporary dermal fillers is a continuously growing field, supported by the ongoing development and advances in technology and biocompatibility of the products marketed. The longer lasting, less immunogenic and thus more convenient hyaluronic acid (HA) fillers are encompassing by far the biggest share of the temporary dermal filler market. Since the approval of the first HA filler, Restylane®, there are at least 10 HA fillers that have been approved by the FDA. Not all of the approved HA fillers are available on the market, and many more are coming. The Juvéderm™ product line (Allergan, Irvine, CA), consisting of Juvéderm™ Plus and Juvéderm™ Ultra Plus, was approved by the FDA in 2006. Juvéderm™ is a bacterium-derived nonanimal stabilized HA. Juvéderm™ Ultra and Ultra Plus are smooth, malleable gels with a homologous consistency that use a new technology called “Hylacross™ technology”. They have a high concentration of cross-linked HAs, which accounts for its longevity. Juvéderm™ Ultra Plus is used for volumizing and correcting deeper folds, whereas Juvéderm™ Ultra is best for contouring and volumizing medium depth facial wrinkles and lip augmentation. Various studies have shown the superiority of the HA filler products compared with collagen fillers for duration, volume needed, and patient satisfaction. Restylane®, Perlane®, and Juvéderm™ are currently the most popular dermal fillers used in the United States.

The risk of alar necrosis associated with dermal filler injection

BACKGROUND Injection of dermal fillers is one of the most commonly performed cosmetic procedures. Serious complications from fillers are rare but potentially devastating to patients and physicians. Skin necrosis, such as nasal alar necrosis, is one of the most feared serious complications of dermal fillers, but there is a paucity of literature on the incidence of such events, as well as potential treatment options. METHODS We present a review of the literature and three cases of nasal alar necrosis after dermal filler injection. CONCLUSION Nasal alar necrosis associated with dermal filler injection is a rare event. Proper technique and recognition of risk factors may reduce the incidence of this complication. Physicians should be aware of early intervention and treatment options should impending necrosis become apparent. Dr. Baumann is an investigator for Medicis, Dermik, Genzyme, and Allergan.

Striae Distensae (Stretch Marks) and Different Modalities of Therapy: An Update

BACKGROUND Striae distensea (SD; stretch marks) are a well‐recognized, common skin condition that rarely causes any significant medical problems but are often a significant source of distress to those affected. The origins of SD are poorly understood, and a number of treatment modalities are available for their treatment, yet none of them is consistently effective, and no single therapy is considered to be pivotal for this problem. With a high incidence and unsatisfactory treatments, stretch marks remain an important target of research for an optimum consensus of treatment. OBJECTIVE To identify the current treatment modalities and their effectiveness in the treatment of stretch marks. MATERIALS AND METHODS Review of the recent literature regarding clinical treatment of stretch marks with emphasis on the safety and efficacy of the newer optical devices and laser applications. RESULTS No current therapeutic option offers complete treatment, although there are a number of emerging new modalities that are encouraging. CONCLUSION The therapeutic strategies are numerous, and no single modality has been far more consistent than the rest. The long‐term future of treatment strategies is encouraging with the advance in laser technologies. The authors have indicated no significant interest with commercial supporters.

Less-known botanical cosmeceuticals.

ABSTRACT:  Complementary and alternative medicine (CAM) has become increasingly popular in the United States during the last 10–15 years. The use of oral and topical supplements falls within this framework. Most oral and topical supplements are based on or include several botanical ingredients, many of which have long histories of traditional or folk medicine usage. Several of the available products derived from botanical sources are touted for their dermatologic benefits. The focus in this discussion will be on a select group of botanical compounds that have been used for dermatologic purposes or show promise for such applications, including: rosemary, polypodium leucotomos, propolis, oatmeal, olive oil, grape seed extract, lavender, mushrooms, and coffeeberry. Other more commonly used products of botanical origin, such as arnica, bromelain, caffeine, chamomile, ferulic acid, feverfew, green tea, licorice, pomegranate, and resveratrol, are also briefly considered.

Randomized, Placebo‐Controlled Study of a New Botulinum Toxin Type A for Treatment of Glabellar Lines: Efficacy and Safety

BACKGROUND A new botulinum toxin type A (BoNT‐A) has been assessed in the United States for treatment of glabellar lines. In April 2009, the US FDA approved the Biologics License Application for a new US formulation of BoNT‐A (Dysport [abobotulinumtoxinA]; Medicis Aesthetics Inc., Scottsdale, AZ). OBJECTIVE To compare efficacy and safety of a single treatment of BoNT‐A with placebo in subjects with moderate to severe glabellar lines. METHODS AND MATERIALS One hundred fifty‐eight subjects with moderate to severe glabellar lines were randomized 2:1 to receive 50 U of BoNT‐A (n=105) or placebo (n=53). Responders were defined as having no or mild glabellar lines at 30 days posttreatment according to investigator and subject assessments (co‐primary endpoint) using the validated Glabellar Line Scale Score at maximum frown. Subject diaries were used to document onset of effect. When conducting the research, the authors conformed to the ethical guidelines of the 1975 Declaration of Helsinki. RESULTS According to investigator assessment, the proportion of responders to BoNT‐A at Day 30 was 89.5%, versus 7.5% for placebo (p<.001); according to subject assessment, the proportion of responders was 75.7%, versus 9.8% for placebo (p<.001). CONCLUSION A single treatment with BoNT‐A (50 U) was significantly superior to placebo in the correction of moderate to severe glabellar lines, with comparable tolerability. Medicis Aesthetics, Inc. provided funding and the material Dysport for this study. Dr. Baumann is a consultant and advisory board member for the both Medicis and Allergan.

A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles

BACKGROUND Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable, biocompatible polymer device. OBJECTIVE We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles. METHODS In this randomized, evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals). Wrinkle Assessment Scale scores were calculated at screening; posttreatment week 3; months 3, 6, 9, and 13 (injectable PLLA or collagen groups); and months 19 and 25 (injectable PLLA group). Safety data were obtained from subject interviews and case report forms. RESULTS Injectable PLLA significantly improved mean Wrinkle Assessment Scale scores (all time points, P < .001). Improvements (up to 25 months after last treatment) were significantly greater (P < .001) than with collagen for posttreatment months 3 to 13. LIMITATIONS Mostly white women and subjects with Fitzpatrick skin types II and III were included. CONCLUSION Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.

Pilot study of the safety and efficacy of myobloc (botulinum toxin type B) for treatment of axillary hyperhidrosis

Background  Botulinum toxin type B (BTX‐B, Myobloc™, San Francisco, CA, USA) was FDA‐approved for the treatment of cervical dystonia in December 2000. It has since been used off‐label for the treatment of axillary hyperhidrosis. However, there are sparse data in the medical literature evaluating the safety and efficacy of Myobloc™ (botulinum toxin type B) for this indication.

Novel hyaluronic acid dermal filler: dermal gel extra physical properties and clinical outcomes.

BACKGROUND Dermal gel extra (DGE) is a new, tightly cross‐linked hyaluronic acid (HA)‐based dermal filler containing lidocaine engineered to resist gel deformation and degradation. OBJECTIVES To develop a firmer gel product (DGE) and compare the efficacy and safety of DGE with nonanimal stabilized HA (NASHA) for correction of nasolabial folds (NLFs). METHODS DGE physical properties were characterized, and 140 subjects with moderate to deep NLFs were treated with DGE and NASHA in a randomized, multicenter, split‐face design study. Efficacy, pain, and satisfaction were measured using appropriate standard instruments. Adverse events were monitored throughout the study. RESULTS DGE has a higher modulus and a higher gel:fluid ratio than other HA fillers. Similar optimal correction was observed with DGE and NASHA through 36 weeks (9 months). Study subjects required less volume (p<.001) and fewer touch‐ups (p=.005) and reported less injection pain (p<.001) with DGE treatment. Most adverse events were mild to moderate skin reactions. CONCLUSIONS DGE is a firm HA gel that required significantly less volume and fewer touch‐ups to provide equivalent efficacy to NASHA for NLF correction; both dermal gels were well tolerated. DGE will provide a comfortable and cost‐effective dermal filler option for clinicians and patients. This trial was sponsored by Mentor Worldwide LLC, Santa Barbara, CA and Genzyme Corporation, Cambridge, MA. Drs. Monheit and Gold are consultants to Mentor. David Burkholder, PhD, is an employee of PD Pharmaceutical Consulting Services, LLC, Guilford, CT. He is a Mentor writing consultant and was paid by the sponsors to provide assistance in the preparation of the manuscript.

Botanicals in skin care products

In recent years, complementary and alternative medicine, together with their various practices, have become increasingly popular and even considered a highly acclaimed disciplineintheWesternworld.Botanicals,whichbydefinition are plant-derived products, play a pivotal role within the market for natural healing. In 2002, one-third of the adult US population was estimated to have used alternative medical therapies, and, in 2003, one-quarter of the adult population reported using herbs to treat a medical condition. Botanicals and the art of herbal medicine are extremely ancient, and have been used in various cultures for centuries, representing the earliest medications used by humans. The current popularity of botanical products has occurred for several reasons, and is based on a greater public access to health information, which has led to the questioning of the approaches and assumptions of allopathic medicine and concerns about the adverse effects of chemical drugs. In contrast, the notion of botanical sources is translated by patients into a ‘‘natural’’ source, which they associate with safety. Theplantkingdomoffersanabundantsourceof substances and, in order to identify new and more potent agents with promising indications to ultimately provide novel cures for diseases, scientistshavesearchedandaresearchingtheflora in remote places of the world. Consequently, new as well as established and well-known botanical ingredients are added tovariousproductsonaconstantbasis. Several of the available products derived from botanical sources have been touted for their dermatologic benefits. Herbal ingredients are used for dermatologic purposes as oral dietary supplements or incorporated into topical formulations. Many botanicals incorporated into skin care products are referred to as cosmeceuticals, a term first introduced by Albert Kligman two decades ago. Cosmeceuticals are defined as intermediary substances between drugs and cosmetics, and, as such, do not require Food and Drug Administration (FDA) approval before being marketed. Unfortunately, this has paved the way for a paucity of controlled clinical trials demonstrating the effectiveness of the various active herbal ingredients. Consequently, most of the botanical substances discussed below lack large-scale, prospective, randomized, blind, controlled clinical trails to assess their actual biologic effects. Thus, within the vast array of botanical ingredients incorporated into skin care products, it is sometimes difficult to choosewhichones trulydeliverwhat theypromise. Adiscussionofallthecurrentlyavailablebotanicalingredients used in dermatology and dermatologic formulations would far exceed the scope of this article. Therefore, it focuses on a select group of the most popular botanical compounds includedorwarrantinginclusionindermatologicformulations intended for predominantly aesthetic purposes. Items selected to be discussed and reviewed below were based on a questionnaireobtainedatarecentdermatologyadvisoryboardmeeting, where dermatologists were asked which botanical ingredients they wanted to know more about. Furthermore, the methods used to select the botanicals discussed below, as well as their respective references, were MEDLINE or scholar.google.com searches for the various botanical ingredient names and words such as topical, skin, skin care, aging, pigmentation, antiaging, inflammation, and free radicals. Extensive files of 923

Understanding and Treating Various Skin Types: The Baumann Skin Type Indicator

The categories used to describe skin types have changed little over the last century, whereas the skin care product market has undergone rapid innovation and exponential growth. There are four basic dichotomies or parameters that have recently been introduced in the Baumann Skin Type Indicator (BSTI) that more accurately characterize skin types. By evaluating skin according to these parameters--dry or oily, sensitive or resistant, pigmented or nonpigmented, and wrinkled or unwrinkled--and thus differentiating among the 16 permutations of possible skin types, consumers can more easily identify the most suitable topical treatments for their skin. This article describes the four parameters that make up the BSTI, focusing on basic science and defining characteristics and summarizing the 16 skin-type variations.