A LOOK AHEAD IN FACIAL PLASTIC SURGERY

Stephen S. Park, MD assumed the presidency of the AAFPRS this past fall. As a new year dawns, Modern Aesthetics® asked him to take stock of facial plastic surgery now and in the years ahead.

Looking ahead in facial plastic surgery, we find the lines between aesthetic and reconstructive surgery getting more blurred. Once regarded as two different subspecialties, the two have blended and integrated with mutual benefits. There was an era where conferences and text books were classified as either reconstructive or aesthetic. Surgical principles were clearly divided, and surgeons found themselves in one camp or the other. As we move forward, we find a larger number of individuals who practice in both areas, excelling in them both; this has led to greater outcomes for our patients. Aesthetic surgeries are incorporating many of the grafts and structural principles frequently needed in facial reconstruction. Similarly, reconstructive surgery is no longer a simple matter of patching holes in the face; facial reconstruction begins with a gameplan that incorporates aesthetic principles in terms of scar camouflage, contour refinement, and restoring symmetry.

The annual meeting of the American Academy of Facial Plastic & Reconstructive Surgery is the single largest gathering of facial plastic surgeons in the United States. Program design has always emphasized an equal representation of both facial aesthetic surgery as well as reconstruction. Selecting keynote speakers and panel moderators has traditionally included leaders from both areas. Today, as our meetings evolve, this distinction is less clear. Many of our instruction courses incorporate wider principles, as experts have come to realize that optimal outcomes are achieved by grabbing the best of both worlds.

Reconstruction following major facial trauma with multiple bony fractures has adapted these principles. No longer are we simply restoring bony fragments but also considering strategic placement of scars and suspension of soft tissues. These modifications have greatly improved outcomes, considering the victims are often younger in age and even small aesthetic deformities can impact quality of life and self-esteem.

Nasal surgery is another complex area that has benefited from the amalgamation of aesthetic and reconstructive principles. Common rhinoplasty goals included removing a dorsal hump or narrowing the nasal tip. Long-terms results have shown ill effects of the techniques used a generation ago. Excessive pinching and narrowing were common sequelae, and nasal obstruction a frequent late complication. Functional and reconstructive rhinoplasty understood the principles of wound contracture and collapse. As a result, those surgeries frequently utilized separate grafts and sutures aimed at creating a structurally strong framework. Those concepts are now widely accepted and used during cosmetic rhinoplasties. This merger of surgical principles has raised the bar in facial plastic surgery.

As we forge ahead, we begin to unravel the tremendous potential of biological engineering. There is an enormous commitment at many levels to merge basic science and clinic care. As this begins to bear fruit, we will see its direct impact on our daily practices. The study of aging skin has produced numerous strategies for impacting its natural progression. There is a wide array of energy sources used to rejuvenate skin and the deeper tissues. Technologic development with optics has put endoscopic surgery in the mainstream and revolutionized surgical approaches and patient convalescence. Today, we can visualize the lumen of our patient's Eustachian tubes! Other technological developments, such as 3-D printing and tissue engineering, will make obsolete some of our current surgical techniques. In-vitro incubation of autogenous tissue will revolutionize the care of patients born with microtia or those who lose a part of their nose from cancer. Great minds are invested in these endeavors and will soon wreak terrific benefits!

Dr. Park is President of the American Academy of Facial Plastic & Reconstructive Surgery and Professor and Vicechairman, Department of Otolaryngology- Head & Neck Surgery; Director, Division of Facial Plastic Surgery at University of Virginia Health System in Charlottesville, VA.


Galderma Launches Restylane Silk for Lip Enhancement and Treatment of Perioral Lines

Galderma launched Restylane® Silk, the first and only dermal filler FDA approved for lip enhancement and the treatment of wrinkles and lines around the mouth in people over the age of 21. Restylane Silk is a smooth gel designed to restore natural youthful definition and symmetry to the lip and mouth area.

“We are proud to announce the launch of Restylane Silk, the first and only product specifically designed to treat the lips and lines around the mouth,” said Stuart Raetzman, Chief Executive Officer of Galderma Laboratories, L.P, and Senior Vice President North America. “There is strong market interest for aesthetic products that can help address the signs of aging in the smile area without resulting in an artificial or “overdone” look, and we are pleased that Restylane Silk will satisfy this need for healthcare professionals and consumers in the US”

“Many of my patients want to address wrinkles in the lip and the vertical “barcode” lines that appear around the mouth with age, but want a natural look without the extra volume,” said Doris Day, MD, NYC dermatologist. “The availability of Restylane Silk presents a new option for these patients that not only helps smooth wrinkles and lines, but also softly restores lip shape and enhances definition without over-plumping.”

In a clinical study involving 221 patients, investigators observed that 77 percent of patients treated with Restylane Silk showed an improvement in lip fullness eight weeks after treatment and 59 percent of treated patients maintained lip fullness six months after treatmet, according to the company.

In the same study, 98 percent of patients treated with Restylane Silk reported a visible improvement in the fullness of their lips 14 days after injection and 76 percent reported that they still had lip improvement at six months following injection.

“The lip and perioral area is the second most common treatment area on the face, yet–until the availability of Restylane Silk–there has not been an FDA approved filler that has been able to effectively enhance this area with truly natural-looking results,” said Kenneth Beer, MD, Director of Kenneth Beer MD PA Cosmetic, Surgical and General Dermatology in Palm Beach, Florida and an investigator in the Restylane Silk Phase III registration trial. “Restylane Silk is an exciting advancement on safe, effective and proven Restylane technology that was engineered specifically to treat the sensitive and delicate area in the lips and around the mouth. The clinical results we observed from the Restylane Silk trial demonstrated significant improvements in lip fullness, the smoothing of wrinkles around the mouth and showed extremely high levels of patient satisfaction.”

Restylane Silk is injected into a patient's lip and/or area around the mouth in one or two sessions as needed and the process typically takes less than one hour. In the clinical study, the results of Restylane Silk lasted approximately six months following treatment. The most common side effects observed following treatment with Restylane Silk were swelling, tenderness, bruising, pain, and redness. The majority of these side effects were mild and decreased in severity within two to seven days. These side effects have also been observed in other lip enhancement clinical trials.


New AAFPRS Survey Reveals Minimally Invasive Procedures Dominate with Focus on Eyes, Cheeks, and Hair

The American Academy of Facial Plastic and Reconstructive Surgery's (AAFPRS) annual survey results offer a look at the top trends in facial plastic surgery, suggesting increasing demand in the months ahead. The survey collected data from a select group of the organization's 2,500 members to reveal the most-wanted procedures of 2014, and offers insight into which treatments are predicted to dominate in 2015.

“We expect the interest in cosmetic procedures–both surgical and non-surgical—to continue to climb in 2015 due to the improving economy, increased consumer awareness and a growing comfort level with the safety of cosmetic treatments,” says Dr. Stephen S. Park, President of the AAFPRS.

According to the AAFPRS member survey, maintenance procedures with little downtime remain the most popular, with four out of five of all procedures performed in 2014 being minimally invasive. Of these, Botox made up about half of all minimally invasive procedures performed, followed by hyaluronic acid fillers, including Juvederm, Restylane, and Belotero.

Of those surveyed, 71 percent of surgeons surveyed saw a rise in combined non-surgical procedures in the same patient for anti-aging treatments without going under the knife. Commonly combined procedures include Botox, fillers, lasers and light-based devices, with or without cosmetic surgical procedures.

The survey results also indicated that eyes and cheeks are key areas of anti-aging focus for men and women. Seventyfour percent of AAFPRS members reported requests for eyelid procedures like blepharoplasty, fillers and laser resurfacing to look less tired, while 63 percent reported people asking to get their cheekbones back with fillers and fat for cheek enhancement and volume restoration.

Hair transplant requests were also up, according to survey results, and is on the radar as an up and coming trend for 14 percent of surgeons, including requests for brow and eyelash restoration.

Remaining competitive in the workforce is an important driver in the decision to have surgery, sited as a factor by 58 percent of surgeons. Patients are also seeking cosmetic procedures due to dissatisfaction with their profile (nose, chin, neck) and because of a desire to look better in selfies, Instagram, and other social media platforms.

The survey found that patients are most concerned about results (69 percent), followed by cost (14 percent) and recovery time (14 percent).


Alphaeon Begins Phase III Study For Its Neurotoxin, Evosyal

The FDA agreed to Alphaeon® Corporations's protocol for its Phase III clinical study of Evosyal™ to treat glabellar lines. Alphaeon acquired the exclusive US and certain international distribution rights to Evosyal, a botulinum toxin type A neuromodulator, as part of its acquisition of Evolus Inc. In the last 12 months, Alphaeon has submitted its investigational new drug application for Evosyal and completed enrollment in its Phase II study.

“We are looking forward to initiating this pivotal study in January with our cohort of experienced U.S. investigators,” said Rui Avelar, MD, Alphaeon Chief Medical Officer. “The agreement with the FDA on our Phase III pivotal study protocol marks another key milestone on the execution of our neuromodulator development plan, “ said Chris Marmo, Ph.D. President of Alphaeon Beauty.

Alphaeon began enrollment of its phase III study on January 14th, 2015.


Dr. Zein Obagi's New Book Presents the Art and Science of Skin Health

Zein Obagi, MD, founder of ZO Skin Health, Inc., has published a new book, The Art of Skin Health Restoration and Rejuvenation: The Science of Clinical Practice, Second Edition (CRC Press, Dec 2014). In it, he reveals the Zein Obagi System of Skin Classification that specifically addresses the variables in skin types and their expected responses to various treatments.

The Art of Skin Health Restoration and Rejuvenation features Dr. Obagi's renowned skin care regimens and state-of-the-art techniques for revitalizing all skin types. Known for his unparalleled expertise with skin peels, he offers step-by-step guidance on reversing photodamage, controlling the pigmentary system, neocollagenesis, and restoration of elasticity. More than 200 color illustrations, drawings and clinical photographs, plus a special chapter from San Diego based dermatologic surgeon Dr. E. Victor Ross on combining laser resurfacing with other techniques, make this volume a resource for plastic surgeons, dermatologists, and skin care professionals.

“Health and skin care occupy a prominent place in the mind of the consumer. The cry for youthful disease-free healthy skin has been heard. I have devoted my career over the past three decades to educating physicians all over the world on how to deal with skin from a different perspective. It is my hope that my new definition of skin health science will establish a well-rounded approach to restore and maintain skin health using fundamentals that can be adopted in clinical practice,” says Dr. Obagi. “We are delighted to present the second edition of Dr. Obagi's comprehensive text that represents the culmination of the key contributions and advances in his illustrious career. This book further establishes Zein Obagi, MD as the preeminent authority in the field of skin health globally,” says James Headley, CEO and President, ZO Skin Health, Inc.

The Art of Skin Health Restoration and Rejuvenation can be ordered online at ZO Skin Health, Inc.


Suneva Medical's Bellafill Approved to Treat Acne Scars

Suneva Medical, Inc.'s Bellafill® is now the only filler on the market approved for the treatment of acne scars. FDA granted approval for Bellafill to treat acne scars based on the outcomes of a double-blinded, randomized, placebocontrolled pivotal study in which subjects were treated with Bellafill® at 10 US clinical centers. Bellafill® was found to be a safe and effective treatment when compared to subjects treated with a control saline injection.

The study required a high threshold for success in which the primary effectiveness endpoint was proven superior for subjects treated with Bellafill® compared to control at six months. A responder was defined as a subject who had 50 percent or more of treated acne scars improve by two or more points on a validated four-point Acne Scar Rating Scale (ASRS). At six months, the response rate for Bellafill® was 64 percent vs. 33 percent for Control (p=.0005). Bellafill® continued to show effectiveness by an unblinded assessment at 12 months (71 percent).

Secondary effectiveness endpoints were evaluated, where both investigators and subjects were asked to evaluate appearance on a Global Aesthetic Improvement Scale that was blinded through six months and unblinded at 12 months. Both groups rated appearance as improved, reaching statistical significance at every timepoint after the touch-up period (at week four) through six months. On the Physician Global Aesthetic Improvement Scale (PGAIS) 84 percent of subjects were rated as improved at six months and 98 percent were improved at 12 months by an unblinded assessment. On the Subject Global Aesthetic Improvement Scale (SGAIS), 77 percent of subjects rated their appearance as improved at six months and 83 percent rated their appearance as improved at 12 months. In addition, subjects were asked to rate their level of satisfaction with acne scar correction treatment on a Subject Assessment of Scar Correction scale (SASC). At six months (blinded), 84 percent of subjects were satisfied while 90 percent were satisfied at 12 months (unblinded).

Bellafill® was studied extensively prior to its FDA approval and proven to be safe and effective for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.

“These types of acne scars affect millions of people and can have a profoundly negative impact on their self-esteem and self-confidence,” said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer at Suneva Medical. “The results of this rigorous clinical study prove that Bellafill® reduces the appearance of acne scars—providing a solution to this widespread skin condition that previously had limited treatment choices. Bellafill® can have a transformational effect on a patient's appearance and in turn, we hope an improvement in quality of life.”

In a Formula PR Independent Study in 2013, more than 70 percent of respondents felt their acne scars negatively impacted their self-confidence, with 92 percent indicating self-confidence would be restored or improved if their acne scars were healed. To help treat disfiguring acne scars, Bellafill® adds volume to the skin to lift and smooth out pitted acne scars to the level of the surrounding skin. The long-lasting treatment is a simple, in-office procedure with minimal to no downtime.

“In the dermatology field, we regularly see patients who live with the burden of acne scarring—a physical and emotional burden that leads many to feel depressed, less energetic and less social. With Bellafill® , we have a tremendous opportunity to remedy acne scars and help patients live a happier, healthy life,” said Dr. Ava Shamban, Assistant Clinical Professor of Dermatology at UCLA, and an investigator in the Bellafill® acne scar study. “The level of acne scar correction Bellafill® achieves is truly impressive and I greatly look forward to using this proven treatment option with patients.” Joana, a clinical study subject, expressed how treatment with Bellafill® has affected her: “Bellafill® has improved my skin, it has lifted it up … and I just feel more positive. I feel more secure about myself. I feel more beautiful going out on the streets and just mingling with people. I feel more confident.”


Lumenis Expands Product Line with a New ResurFX System

Lumenis Ltd. launched its new ResurFX™ laser system for fractional non-ablative skin resurfacting treatments. This new ResurFX system is a stand-alone desktop solution, which builds upon the successful launch of ResurFX module for the M22™ multi-application platform. The system debuted at the International Master Course on Aging Skin (IMCAS) Annual World Congress 2015, which took place in Paris from January 29 to February 1, 2015.

The new ResurFX system offers advanced features to improve efficacy and patient comfort, allowing practices to expand their non-ablative treatment offering. Lumenis' CoolScan™ technology ensures precise and safe energy delivery with continuous contact cooling, while the ResurFX system's customized treatment parameters allow aesthetic professionals to choose from more than 600 combinations of shape, size, density, and energy delivery to customize treatments. ResurFX needs only one pass to be effective, saving practices time and protecting the patient's skin. With no disposables, the new ResurFX is also costeffective for growing practices.

This extension in the field of skin resurfacing will allow physicians to choose the best solution for their practices:

A full multi application M22 platform with ResurFX, which also features the Lumenis Gold Standard IPL with OPT, Long Pulsed Nd:YAG and Q-Switched Nd:YAG.

A stand-alone desktop version of the ResurFX with a compact sleek design and user interface.

“We have seen such a dramatic rise in fractional nonablative skin resurfacing because the procedure provides excellent results without the long downtime associated with other cosmetic procedures,” said Dr. Matteo Tretti Clementoni of Istituto Dermatologico Europeo. “ResurFX is the leading solution in this space because it provides the best balance of efficacy and patient convenience – some of my patients are even coming in for ResurFX treatment as a ‘lunch-time' skin rejuvenation procedure.”


RESEARCH BRIEFS

POPULATION ANALYSIS OF THE PERFECT BREAST

Following up on previous research that identified key objective parameters that define the aesthetic ideal of the breast in a study of 100 models with natural breasts, researchers conducted a morphometric analysis of the opinion of the general public on ideal breast proportions was surveyed. One thousand three hundred fifteen respondents were asked to rank the attractiveness of images of four women with varying breast sizes. Each of the women's breasts were morphed into four different proportions. One of the key features was the upper pole–to–lower pole percentage proportion, corresponding to ratios of 35:65, 45:55, 50:50, and 55:45. The rankings were analyzed according to population demographics, and the effects of age, sex, nationality, and ethnicity were evaluated. The responses of 53 plastic surgeons were included. Results showed that breasts with an upper pole–to–lower pole ratio of 45:55 were universally scored highest, in particular, by 87 percent of women in their thirties (n = 190), 90 percent of men (n = 655), 94 percent of plastic surgeons (n = 53), 92 percent of North Americans (n = 89), 95 percent of South Americans (n = 23), 86 percent of Europeans (n = 982), 87 percent of Caucasians (n = 1016), and 87 percent of Asians (n = 209).

The authors concluded, :”his study reaffirms the authors' previous findings that the 45:55 ratio has universal appeal in defining the ideal breast. The authors propose that this proportion should be used as a basis for design in aesthetic surgery.” —Plastic & Reconstructive Surgery: September 2014; 134(3): 436–447.

GAUGE EARLOBE DEFECT STUDY

The use of gauge earrings causes earlobe defects and, at times, significant contour distortion. Noting that simple closure leads to inadequate results in most cases, a recent study offers a stratified approach to assessing the earlobe deformity as well as specific reconstructive techniques tailored to each type of deformity to restore normal size and contour. Authors presented a case series of 20 patients who requested earlobe reconstruction with at least one year of follow-up. Earlobe deformity can be classified into three groups: small, which can be closed primarily; medium (with radial earlobe distortion and thinning), which requires advancement flaps or wedge excisions; and large (with inferior displacement of earlobe border and vertical axis abnormalities), which requires advancement flaps and excision of redundant tissue. Excellent final earlobe appearance is usually observed at six months postoperatively.

The authors found that soft-tissue loss and contour abnormalities of medium and large defects require more complex repairs to prevent excessively narrowed lobes with loss of normal rounded contours. Obtaining a normal-appearing ear is of the utmost importance for patients who require a more professional appearance. —JAMA Facial Plast Surg. Published online December 18, 2014. doi:10.1001/jamafacial.2014.1249