New Drugs and Therapies for 2016: Cosmetics

Drs. Neal Bhatia and Ted Rosen

Part 7 of an 8-part series on the large number of new topical and systemic medications that have become available or moved closer to approval in the last 12 months.

Injectable Deoxycholic Acid

In April, 2015 the FDA approved deoxycholic acid (Kybella®), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. Kybella, a cytolytic drug, is identical to the deoxycholic acid that is produced in the body and which helps absorb fats. When properly injected into submental fat, the drug destroys fat cells. It is the only approved for the treatment of fat occurring below the chin (Figure 4). The safety and effectiveness of Kybella for treatment of submental fat were established in two clinical trials that enrolled 1,022 adult patients with moderate or severe submental fat. Results showed that reductions in submental fat were observed more frequently in participants who received deoxycholic acid vs placebo.

It is important to note that Kybella can cause serious side effects, including nerve injury in the jaw that can cause an uneven smile or facial muscle weakness, and trouble swallowing. The most common side effects seen with this new treatment are swelling, bruising, pain, numbness, redness and areas of hardness in the treatment area.

Neuromodulators for Skin of Color: Maui Derm 2015

Valerie D. Callender, MD

In this presentation at Maui Derm 2015, Dr Callender reviews the use of neuromodulators in skin of color. When we think about neuromodulators in skin of color, we need to think about how these aesthetic patients present in our office.

The concept of global beauty is the desire to maintain a beautiful, youthful appearance. This concept crosses all racial, cultural, and economic barriers. It’s more than just symmetry, size, and shape of facial features. So what is global beauty? It’s the appearance of smooth, even skin complexion, as well as the absence of rhytids, volume loss, and skin laxity. Remember that the amount and type of melanin determines one’s skin color. When estimating a person’s age, skin color uniformity was amongst the most important feature.

When we think about race, ethnicity and culture the definitions are very important.

  • Race: an objective term that includes people of the same heritage who may or may not share genetic similarities but possess similar physical qualities.
  • Ethnicity: a subjective term, that is self-assigned, each person determines the group that they most readily identify with & feel most connected to.
  • Culture: refers to a set of patterned beliefs, values, conventions, or social practices of a group & may or may not take into account the concepts of race or ethnicity.

Often times we interchange these terms and it’s important for us to understand that the “Face of America” is changing. Our current population is over 301 million with people of color being the fastest growing segment. Skin lightness is a global concern. Skin color is a sign of health, attractiveness and youthfulness; it also affects job and marital prospects as well as earning potential.

What really changes things is the media as it depicts beauty and youth almost simultaneously. Dr Callender feels that it important for all of our patients, among a variety of ages and skin types, that beauty is really skin deep.

Cosmetic Concerns Among Women of Color

A survey was conducted regarding cosmetic concerns in 100 women (81 African American, 16 Hispanic, and 3 Asian). The mean age was 41 years old. 86% of the women were concerned with hyperpigmentation or dark spots; 80% were concerned with blotchy, uneven skin; 77% found combination oily or oily skin was of concern; 49% claimed sensitive skin; and 40% found that rough skin was an issue. (Grimes PE, Dermatol Clinics. 2000)

Cosmetic Procedures in 2013

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Reference: ASAPS.Cosmetic surgery national data bank statistics. http://www.surgery.org/professionals/index. Accessed Sept 2014.

Facial skin again is common across all ethnic and racial groups and varies in severity, age of onset and cultural impact. Skin of color patients demonstrate signs of rhytids at a later age than do individuals with fair skin and signs of facial aging in darker skin occurs 10 to 20 years later than in Caucasians. This is due to the photoprotective properties of epidermal melanin. The mean protective factor from UVB in skin of color is 13.4 versus 3.4 for white skin. Remember that mid-facial volume loss and prominent tear troughs are striking features of skin aging in African Americans and perioral rhytids are less common. Photo-aging differences in Hispanics and Latinos are less characterized, but vary considerably due to the broad range of skin types in this population. As dermatologists, we must be aware of nuances surrounding facial rejuvenation for patients with diverse racial and ethnic backgrounds.

Botulinum Toxin-A in African Americans

There are several published studies looking at neuromodulators in skin of color. One of the early studies of onobotulinum toxin by Grimes and colleagues found that there was really no difference in terms of adverse events in skin of color patients and maximal response was observed on day 30 with 92.4% and 100% response, respectively. (Grimes, Shabazz.Derm Surg 2009;35(3):429-436) Kane and colleagues studied abobotulinum toxin with different dosing and also found no significant racial or ethnic differences in safety. African American subjects had a slightly higher rate ocular adverse events and a lower rate of injection site reactions. The response rates and duration were slightly higher in African American subjects (177 days in AA versus 109 in overall population), the reason for this is unknown. (Kane, et al. Plastic & Reconstructive Surg 2009;124(5):1619-1629.)

When we look at neuromodulators in Asian patients, we see differences in response rates with 10 units versus 20 units; however, there were no differences in adverse events. (Harii & Kawashima. Aesth PS 2008;32(5):724-730.) What are we really looking for among all of these studies is safety issues and that’s what’s important across all of these studies. A study of onobotulinum toxin in Brazilian patients, followed by TCA 35% peel and manual dermabrasion 7 days post-injection resulted in transient PIH in 33% of the subjects. Additionally, significantly less wrinkles were seen from 90 days to three years in subjects treated with onobotulinum toxin versus placebo. (Kadunc et al. Dermatol Surg 2007;33(9):1066-1072.)

Clinical Pearls for Skin of Color Patients

  • Appropriate lighting and close examination is needed in identifying and avoiding blood vessels in darker skin
  • Post-inflammatory hyperpigmentation (PIH) is uncommon but may occur from needle injection points
  • Many Eastern Asian patients desire to have wider & rounded appearance of the eyes. BTX-A treatment using 2u lower eyelid & 12u crows feet is a nonsurgical option for these patients (Flynn, et al. Derm Surg 2001;27(8):703-708.)
  • In Eastern Asian patients, the dose should be a six-point injection to the masseter (three-points per side for a total of 50-60 units). (Ahn BK, Kim YS, Kim HJ, Rho NK, Kim HS. Consensus recommendations on the aesthetic usage of botulinum toxin type A in Asians. Dermatol Surg 2013 Dec;39(12):1843-60.)

Conclusions

In general, there are no racial or ethnic differences in the treatment of facial lines with botulinum toxin-A. Safety and efficacy in all skin types has been demonstrated in many published clinical studies. As with any aesthetic procedure, understanding and consideration of cultural diversity must be given to each patient’s individual aesthetic ideals.

Judy L. Seraphine, MSc-Maui Derm News Editor

 

 

 

 

 

 

Botulinum Toxin: Science and Evidence Data, Dose, Duration, Dogma

Joel L. Cohen, MD

In this presentation, Dr. Cohen discusses the neuromodulators that we commonly use and how to best apply the science and evidence into clinical practice. Dr. Cohen spends about 40 percent of time in practice doing Mohs surgery and the other 60 percent is dedicated to aesthetics.

It’s important to remember that we typically don’t focus in one area but rather treat assess patient’s full face and multiple regions, and we tend to use a combination of therapies/treatments (neuromodulators, fillers, lasers, and other energy-based devices such as radiofrequency and ultrasound). Clinical research is important to us, as clinicians, for a number a reasons — not only does it allow us to see what products are coming up on the horizon, but it affords us the opportunity to experience these therapies first-hand in clinical practice.

Currently, we have three neuromodulators approved for aesthetic use; onabotulinumtoxinA ((Botox), abobotulinumtoxinA (Dysport) and incobotulinumtoxinA (Xeomin). The important concept here is that these products are probably more similar than they are different.

 

BTX-A On-label Aesthetic Uses

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Of note, when you go to other countries, especially in Europe, you will see a different spectrum and wider-spectrum of approved aesthetic indications for these products.

We know, from clinical data, that botulinumtoxin can make patients feel better about themselves and can help them outwardly convey their inner emotions more appropriately. Many patients want to delay the outward appearance of aging as well as simply “look their best”. (Finn, Cox, Earl. Social Implications of Hyperfunctional Facial Lines. Dermatol Surg 2003;29:450-455.)

A double-blind, randomized, placebo-controlled health outcomes survey conducted by Dayan and colleagues analyzed the effect of botulinumtoxin type A injections on quality of life and self-esteem. The researchers found that the injections result in improvements in quality of life (QOL) and self-esteem. Additionally, botulinumtoxin-naïve patients demonstrated greater improvements in QOL and self-esteem than participants previously exposed to botulinumtoxin. Moreover, botulinumtoxin-familiar patients demonstrated sustained improvement in QOL and self-esteem as compared to botulinumtoxin-naïve patients, even when injected with placebo.

All of the approved botulinumtoxin type A products have a 150 kD botulinumtoxinA core neurotoxin protein. Incobotulinumtoxin (Xeomin) lacks the accessory proteins that are naturally produced by clostridial bacteria, which Botox and Dysport maintain.

When you look at the clinical studies, remember that there are different comparisons and different endpoints. Non-inferiority studies tend to compare two products at very specific time points. One noninferiority study compared incobotulinumtoxinA to onobotulinumtoxinA at four weeks and 12 weeks, as assessed by investigators, a panel of independent raters, and patients. This study demonstrated that incobotulinumtoxinA is equally as effective as onabotulinumtoxinA in the treatment of glabellar frown lines and both products were well tolerated — at the specific timepoints studied. There are; however, issues with non-inferiority studies. Because there are two time-points, there may be a missed evaluation of the duration of efficacy and a “waning effect.”

If you look at different demographics of your study cohort in some clinical trials, you’ll see that in some studies it’s really reflective of what we do in clinical practice; however, in other studies, it may not be – such as a disproportionate number of patients being quite young. These are issues that need to be considered when we’re looking at overall responses and comparisons among different products.

We also need to think about “low-powered” comparisons. In a comparison of two botulinum toxin type A preparations for the treatment of crow’s feet (Prager, et al), there were only 21 patients in this study. This may not be enough to tease out any major differences between the products in terms of the number of patients studied.

So, in short, there are 3 botulinum toxin products available in the US. It’s very difficult to make direct comparisons. These are different products and we need to consider the fact that the dosing can be different and the studies can be designed differently in terms of non-inferiority, demographics and power as well as an evolution of different study endpoints (2-grade improvement versus 1-grade).

We are beginning to see a shift towards more stringent primary endpoints. A randomized, double-blind, placebo-controlled phase III trial, conducted by Hanke and colleagues, investigated the efficacy and safety of incobotulinumtoxinA in the treatment of glabellar frown lines using Composite Endpoint Treatment Success (CETS), i.e., looking at a two-grade improvement. If you look at how often physicians saw a two-grade improvement versus patients, you will see about 48 percent.

 

Composite Endpoint Treatment Success

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Remember that it’s difficult to compare data as previous studies often used a one-grade improvement; therefore, demonstrating a larger responder rate and a longer duration of treatment.

The pivotal trial with Botox for the lateral canthal lines required at least a two grade improvement from baseline on both the investigator’s and subject’s assessment of CFL severity at maximum smile using the 4 facial wrinkle scale. At day 30, we see a responder rate of 25.7%. Dr Cohen states that we know we have seen higher responder rates than this; however, because there has been a chance in the way in which the FDA wants this to be assessed, i.e., patient and physician composite scores, the numbers are lower.

What about conversion ratios?

Again, remember that these are different products and we need to look at them as such. Various studies have looked at the concept conversion ratios, but that may be difficult to compute in clinical practice. Regulatory agencies worldwide have recognized that these products are not interchangeable.

 Some Other Things to Consider…

When we look at patients, specifically speaking about the lateral canthus, not everyone needs the exact injections that were used in clinical trials. There have been studies, dating back to 2003, looking at different patterns of injections and the way that different people look. It’s important to identify these features in your patients and individualize therapy. When Dr Cohen looks at a patient and he/she is superior dominant, he may give more of the neuromodulator up high, and a little bit less in the middle or below. Keep in mind that on that same horizontal is the bunny line and the contraction of the nasalis. Also along this horizontal is the pharmacologic brow lift.

If we understand the anatomy that the orbicularis oculi pushes our brows down and the frontalis lifts them up, then if we inject the one site where you’re getting the maximum pull down below the lateral, you may see better improvement in the lateral brow lift we can sometimes see when we treat the lateral orbicularis oculi.

Drs Cohen and Dayan conducted an open-label, randomized, dose-comparison study of botulinum Toxin Type A in the treatment of dermatochalasis. They found that a single-site injection of botulinum toxin type A in the lateral infrabrow can offer effective treatment for mild to moderate upper eyelid dermatochalasis—with perhaps a couple of millimeter lateral brow lift at best.

We know that when we look at patient’s brow positioning, there are some that should not be injected with a neuromodulator in the off-label area of the forehead. There was an important article that was published in JAMA Dermatology last year that looked at not only a grading scale for dermatochalasis, but it also discussed the factors associated with dermatochalasis. (Jacobs L, et al, 2014) From a grading scale, there are four categories for sagging eyelids (mild, moderate, severe, very severe). Specific risk factors associated with sagging eyelids include, age, male sex, lighter skin color, smoking status and higher BMI. In many cases, people “blame” genetics for sagging eyelids; however, we can see that there are things that we can do to intervene to help reduce the risk.

Combination Delivery

After the approval of Radiesse with in-office adding of anesthesia in the same syringe, some physicians began to use the same adaptor to combine fillers and neuromodulators. Dr Cohen doesn’t feel that this is a good idea; in fact, he believes that it probably does not save time, leads to an unstandardized mixture, and likely leads to less precise injections – as there are simply some areas where you don’t want toxin but you do want filler. So combination in the same syringe of toxin and filler in Cohen’s view is not a good idea, but combination of toxin and filler in their respecitive different syringes is still a good concept.

When it comes to the lower face and the area around the mouth, a study conducted by Carruthers et al indicated that both physicians and patients saw a greater improvement when the patient was injected with both the hyaluronic acid dermal filler and a neuromodulator. (Carruthers A, et al. Dermatol Surg. 2010;36:Suppl4:2121-2134.

And other studies have shown synergy with the combination treatment of different regions with toxin and filler. A 2003 study of Botox plus Restylane demonstrated that if you inject patients with Botox and then have them come back for Restylane, it has a longer tissue residence time in terms of filler and correction than if you injected Restylane alone (18 weeks versus 32 weeks.)

Dosing

Many of us have seen an overall change in practice patterns when it comes to dosing. In some areas, like especially the forehead, we have shifted from higher doses of toxin to lower doses in order to achieve a more natural, relaxed look for our patients. In the forehead, for example, Dr Cohen and other colleagues who participated in the more recent PRS journal consensus, now inject about half of the dose they previously used in the forehead — thus creating often a more natural look, simply softening the musculature, and maintaining brow shape and positioning better. There’s a lot to consider with regards to neuromodulators. We have seen where NOT to inject, but it’s important to maintain brow positioning and shape as well as symmetry.

There are very specific grading scales that can be useful in clinical practice and Dr Cohen recommends incorporating them into your regimen. This is helpful when discussing the goals of therapy with patients—for instance, for the forehead “softening of the musculature”.

 

 

 

 

 

 

Facial Reflation and Contouring: Clinical Pearls

B. Kent Remington, MD

Dr Remington provides key takeaway points:

  • With time we all sink – sag and wrinkle. The focus for facial fillers is to improve facial deflation the sinking part of the aging process. Injectable collagen [Zyderm] became available in 1981 and most us were taught to be line chasers with horizontal injections –serial puncture – radial techniques and fanning and ferning – all retrograde methods. None of these techniques are very effective to restoring facial deflation.
  • Inflation is an injectable vertical technique to lift by mostly antegrade methods the deflated facial zones with contouring up to the level of a more youthful appearance.
  • This is not to be confused with Inflation –where the areas injected are injected far beyond what the patient once had. Reflation restores the patients normal volume loss and not beyond.
  • In our female aging patient with areas of deflation, “Facial Reflation” and Contouring re-creates feminine natural smooth facial curves and softness.
  • In Men, Facial Reflation and Contouring re-creates masculine structure and strength.
  • To Create great results with facial fillers it is important to have “Double Vision” The 1st Vision is to be able to see in 3rd dimension what the face needs and be able to demonstrate this to your patient. The 2nd Vision is to be able to “See the end result” before you start.
  • It is not possible to have facial shadows without light and it is also not possible to have Youthful Facial Highlights without shadows. Youthful faces have light and shadows all in the right places.
  • In restoring the youthful cheek both in volume and in shape with the apex mathematically just right involves understanding the phi and math of the face. Reflating and contouring the cheek shadows caused by aging and not injecting and filling the youthful “cheek form shadow” is a delicate balance.
  • The Yin and Yang of facial light and shadows are not opposing forces they are complementary. Faces have both Yin & Yang aspects – Shadows and Light for Balance and Harmony. To see the aging face clearly, do not just look at the facial highlights, but also focus on the important shadows of deflation.
  • Converting your pre-treatment facial photographs to black/white makes determining the shadows that need reflation much easier. Also a “Split Face” study of the current photo and a youthful one helps show the shadows of youth to leave untreated and the shadows of deflation you need to focus on.

The Aesthetic Consult: Clinical Pearls

B. Kent Remington, MD

What is the “real reason” our patients want to look better? Dr Remington provides key takeaway points on his aesthetic consult…

  • Aesthetic physicians are essentially “Image Enhancers” as the patients self image, self esteem and self concept have a direct impact on how they feel about themselves. A youthful appearance is the best thing you can wear. It is therefore paramount at some time in the consult to find and point out the patients positive facial features.
  • The main purpose of all Facial Aesthetic consults is to find the “Real Reason” why your patient wants to look better – it is almost always very little to do with the initial stated reason.
  • It is important to focus on the aesthetic patient that has a great interest and desire to look more youthful. This patient may not have the winning ticket for the best genetic lottery pool or be on a unlimited budget. It’s not their hormone level or the size of their wallet. It’s the wiring of their DNA some patients are just wired for aesthetics.
  • We –like are patients look with our eyes, but we see with our brains. The eye also sees what it wants to see. Most patients have severe selective monofocus. The patient’s perception of reality and reality are often not the same. Our focus is the whole face and converting patients to looking at the whole face and starting a renovation project is like restoring a painting – step at a time.
  • Aging and getting older is not a choice – looking younger is a choice – doing nothing is also a choice,
  • Faces are all about genetics, genetics are all about biology, biology is about physiology, physiology is about physics, physics is all about mathematics – therefore faces are all about Math — this is not left brain math but right brain math. Creating the extraordinary out of the ordinary are all fruits of good mathematics combined with art.
  • Aesthetic clues are like fish in the water – the fish are not aware of the water – they don’t see it or feel it. This is the same with many Aesthetic Physicians during the consult they do not connect with the patient and engage the patient – two essentials to a high consult to treatment percentage.
  • Photography – if possible a dedicated room with the same consistent light and background and camera settings. It cannot be understated the importance of a “baseline pretreatment” photos front view – ¾ views and profiles repose and animated.
  • Have all your aesthetic consults being in a good resolution facial photo in their 20’s to scan with their current photos taken in your clinic– not trying to make them look 20, but the importance of comparing past balance proportion harmony and symmetry to the present– or lack of. This whole exercise helps patients understand why we look at and treat the whole face.

The Aesthetic Consult

Kent Remington, MD

Dr Remington is an internationally recognized leader in the aesthetic dermatology industry. In this presentation, he discusses his novel approach to the aesthetic patient. Dr Remington’s aesthetic consult is quite different from that of other dermatologists. We all want to reinvent ourselves and it’s necessary to keep up with the ever-evolving field of aesthetic dermatology.

How can we get patients who are on a budget to go ahead and agree to a fairly comprehensive procedure/project? It’s all in the consult. It is important, as physicians, to recognize that patients are skeptical, suspicious, leery, tentative, intimidated, apprehensive, tense, cautious, and so on when it comes to facial rejuvenation. Dr Remington stresses the importance of “peeling all of these layers off” to be able to have some connection and engage with your patient(s). Remember “one size fits none.” Patient’s are not paying for cost, they’re paying for good results. If you look at patient’s animations, not everyone is the same. We have to be able to teach our patients what their face really needs. Dr Remington feels that most injectors just follow what everyone else is doing. It’s easy to follow what everyone else is doing; we are extremely busy in our clinical practices and we can tend to confuse being busy with accomplishment. The old aesthetic rule was “if it ain’t broke, don’t fix it.” The new rule is “if it ain’t broke, break it and make it better.”

The aesthetic consult requires that you look at the “whole face.” Attention to detail should be your major focus. Patients tend to have selective focus. They come into your office with a focus on their nasolabial fold or their frown zone and that’s it, they don’t see anything else. Patient’s perception of reality and reality are often quite different…we look with our eyes and see with our brains.

Patients expect value for their dollar and they expect to be treated well, i.e., they don’t want good results, they expect outstanding results. This requires careful planning on the part of the physician by balancing neuromodulators, fillers, surgery, lasers, energy devices and fat busters with cost. Its not about dollars, its about results. Patients are willing to pay for good results. Dr Remington has five nurses who work with them and they take a very detailed approach to facial reflation and contouring.

Faces are all about genetics, genetics are about biology, biology is about physiology, physiology is about physics, and physics are about mathematics; therefore, faces are all about math. You have to have a plan in mind, eg., where is the peak of the brow? What is the width of the lip? As far back as 1934, makeup artists were given guides to the face on where/how to best apply makeup based upon facial dimensions. Dr Remington refers to his process as “facial beautiPHIcation.” “Creating great results is a result of good mathematics, I am not talking about left brain math, but right brain math”

You want to uncover the “real reason” that your patient is interested in looking better. You can discover the reasons not by questioning, but by intuitively interacting with your patients.

Dr Remington asks every patient to bring in a good photo of him or her. Usually, this is a picture that was taken in his/her twenties. Dr Remington isn’t trying to make them look twenty, but he wants evaluate past symmetry,balance, proportion and balance or lack thereof. A picture makes it much easier to create what you’re trying to show them. Often times, he will split the face in a computer screen set up to show the patients youthful photo beside the current one. This helps patients see clearly why we need to look at and treat the whole face in a planned restoration project. Not to make them look different, but to restore what they used to look like A dedicated camera room with a high-resolution monitor is a MUST, according to Dr Remington because this is where he can do much of his education and visual perception for his patients. Sometimes Dr Remington will convert the color photos to black and white because it is easier to show contrast, volume loss and wrinkles.

Good results come from commitment to a detailed consult,.In North America, many people come from a combination of ethnic backgrounds. Dr Remington spends a lot of time with his patients discussing their genetics. Why is this important? We want to find out the positive part(s) of their genetics. He tries to not only retainthat part but also, accentuate it. Aesthetic physicians need to train their eyes to be like video cameras with Panavision friendly focus; but the aim is on information and figuring out everything about the patient. You must understand where the patient is coming from—this comes from connecting and engaging with your patient.

Dr Remington and a colleague found that there are seven types of consulting styles.

  • Socializer
    • Initially impress patients
    • Rarely get past the social part
    • A lot of odour, little substance
  • Consultants
    • Good listeners
    • Go with patient’s monotherapy focus
    • Succumb to patient’s unreasonable requests
  • Closers
    • Smooth, slick style
    • Up sell rather than up serve
    • A lot of dancing to seal the deal
  • Storytellers
    • Love to detail patient case studies
    • Forget to focus on the bigger picture
    • Try to endear themselves to the patient
  • Focusers
    • Know the science of all their products and devices
    • Discuss and treat selective focus areas of the face
    • Tunnel vision
  • Narrators
    • Love to listen to themselves talk
    • Discuss procedures like robots
    • Do not recognize that “one size fits none”
  • Face whisperers
    • Engage the patient and ease their apprehension
    • Up serve rather than up sell
    • Calm, focused assertive energy

Patients can sense your uncertainty. You have to present with confidence so that your patient(s) understand and agree with the procedures that you recommend. Remember that words are extremely powerful. “Words are the most powerful drug used by mankind. Not only do words infect, egotize, narcotize and paralyze—they get into color even the minutest of brain cells.” (Rudyard Kipling) Words are hypnotic and they can make a huge difference to your patient.

Dr Remington has discovered that an aesthetic patient is driven to look more youthful not on the size of their wallet or their hormone level it’s in their DNA. You have to determine which patients are aesthetically wired, and which are not.

Men and women focus on different things when they look in the mirror. Women tend to focus on their eyes and their lips and men tend to focus on spots. Again, patients have selective focus. What they see and what is actually real are often quite different. As aesthetic physicians, we have to gently teach patients what we see. We are image enhancers. We want to find and point out the patient’s positive facial features. This is important for our patient’s self image, self-esteem and self-concept. How we think we look has a direct influence on our appearance.

It is important to take a “global approach” to facial restoration and beautiPHIcation. Physiognomy (face reading), personology (reading personalities) and phenomenology are becoming more and more a part of our interest as aesthetic physicians as this gives us the information we need to know about our patients.

Clinical Photography

You have one opportunity to get a baseline, pre-treatment photo. As previously mentioned, a dedicated camera room with a high-resolution monitor is highly recommended. You want to evaluate your patients in good lighting. Start early with your photography, you can teach your patients from the photos.

One of the most important things that Dr Remington does for teaching is insisting on the patient bringing in his/her old picture so he can split the face to show the difference over the years.

If you look at aesthetic clues about who is interested in aesthetics, there are verbal clues, non-verbal clues, and visual clues—be observant. You need to recognize patients who have had procedures in the past e.g., prosthetic dental work, face lift, rhinoplasty, those who style/dye their hair, patients with special events or milestones coming up such as a wedding or anniversary, and patients with special circumstances, e.g, their partner is younger or a milestone birthday.

In conclusion, it is imperative that you to take a global approach to your patients. A combination of procedures may be necessary for optimal results. Remember to connect with your patients and engage them in the process as our current aesthetic patients world wide expect outstanding clinical results.

MauiDerm News Editor-Judy Seraphine

Functional Facial Anatomy: A Primer

Sandy Tsao, MD

Where are the safe areas to inject? What can we do in certain areas that we cannot do in others? In order to answer these questions, we need to understand the basic facial anatomy.

Remember that it only takes one complication to understand how significant the facial anatomy can be. As the neuromodulators change and as we become more knowledgeable about treatments, we have a better perspective. When we’re talking about facial anatomy, we’re thinking about the muscles of facial expression that run from the skull to the skin. These muscles are innervated by the facial nerve and are sphincters and dilators of the eyes, nose and mouth. It is key to understand that the wrinkles that we’re seeing are actually perpendicular to the action of the muscle. This is very important for us when we’re thinking about where the lines are and how we would like to get rid of them.

The facial skeleton is composed of fourteen stationary bones and the mandible. These fourteen bones form the basic shape of the face and are responsible for providing attachments for muscles that make the jaw move and control facial expression.

The facial nerve divides into five terminal branches for muscles of facial expression:

  • Temporal
  • Zygomatic
  • Buccal
  • Marginal mandibular
  • Cervical

If you’re ever cutting or injecting into any of these areas, it is critical to think about the insertions and the direction of these nerves.

The skin of the face is supplied by the trigeminal nerve (V), except for the small area over the angle of the mandible and the parotid gland that is supplied by the great auricular nerve (C2 and 3). The trigeminal nerve (V) divides into three major divisions—the ophthalmic (V), maxillary (V2), and mandibular (V3) nerves.

The arterial supply comes from the common carotid artery and it will innervate and branch thoroughly throughout the scalp and the facial structures and drain via the jugular nerve. Why is this significant? Every time we inject, there is always the potential for a hematoma, a bruise or an injury. Understanding where that vasculature is and where the drainage spots are is helpful to minimize side effects.

Muscles

The Temporoparietalis is key to us because of the temporal nerve. This muscle allows us to raise our ears, widen our eyes, and retract our temples. This can be an ideal place to add a filler; however, it is critical to understand that the temporal nerve is a little deeper. Across the face we have the Frontalis muscle that allows us to raise the eyebrows, widen the eyes, and furrow the forehead. We often take advantage of this to minimize and soften the horizontal lines across the face.

In direct opposition are the depressor muscles of the upper face, which include the Corrugator muscles. These muscles interdigitate with the frontalis; they actually displace the brow inferomedially creating the frown. The Corrugator muscles work in conjunction with the Depressor Supercilii that causes medial brow frowning. Last not but not least is the Procerus muscle—a very important muscle because it not only displaces the brow medially, but also creates the horizontal bands that many patients are interested in improving.

Clinical Pearl-When you are influencing one set of muscles, almost always there is another muscle that is acting against it.

The Transverse Nasalis muscle is a muscle is that interdigitates with the opposite muscle as well as the Procerus muscle. This is the muscle that allows for depression of the cartiginous part of the nose as well as drawing the ala toward the septum. This muscle is what we refer to as the “bunny lines.” We want to be very careful with injections here because too low of injections can infect the smile lines. This is one muscle into which we directly inject and try to keep on the higher edge of the muscular complex.

The Orbicularis Oculi is muscle that has two parts—palpebral and orbital. It has two components, each of which need to be thought about because influence of one portion may influence another part of the muscle. This muscle helps us to open and close our eyes, allowing us to form tears. When we’re addressing this muscle, we’re generally dealing with the orbital aspect of the muscle. When injected correctly, this can provide softening of the crow’s feet. If you inject the Orbicularis Oculi too deeply, you can infect the smile by influencing either the Zygomatic Major or Minor or even the Labii Inferioris Superior.

Clinical Pearl-It is pertinent to understand your endpoints because you will have migration of the neuromodulators over a three- to four-month period of time.

Levator Muscles of the Mouth

The Zygomaticus Major helps to raise the angle of the mouth superiorly and posteriorly and helps our mouths smile or laugh. The Zygomaticus Minor runs medially to the Zygomaticus Major and allows the upper lip to displace superiorly and deepens the nasolabial furrow allowing us to make an expression of contempt.

What about the rest of the mouth? The Depressor Labii Inferioris displaces the lower lip inferiorly and slightly laterally. The consequences of which will allow for displacement of the skin downward and lateral pull to the mouth and potentially an uneven smile if the Mentalis muscle is injected to superiorly. The Risorius muscle is one of our elevators and as a consequence it displaces the skin of the cheek posteriorly, it stretches the lower lip, and displaces the corners of the cheek downward and lateral and we see a nice grin.

The Levator Labii Superioris Alaeque Nasi is an important to muscle to know because it dilates the nose and actually raises the upper lip. The Levator Labii Superioris muscle is responsible for raising the upper lip. This is one of the muscles that we like to target when we’re trying to get less of a grin. When a neuromodulator is placed into these muscles, you can see less “gummy” show in the upper lip.

The Orbicularis Oris is also a very critical muscle. It is quite large and has a number of insertions into it. This muscle helps to bring the lips together and protrude forward. The Buccinator muscle merges with the upper and lower lip muscles and helps to compress cheeks against the teeth along with tensing and contracting the cheeks for a nice pucker. Injection into the vertical Rhytids will allow for some softening of the lines created by that muscular action.

The Depressor Anguli Oris helps as a depressor muscle. It depresses the angle of the mouth resulting in an expression of grief. This muscle is often times sought after as a muscle either to relax by a neuromodulator or to uplift by dermal filler. The Mentalis elevates and protrudes the lower lip allowing for an expression of doubt. This is a critical area to avoid surrounding muscles so that the smile itself is not influenced.

The Platysma muscle is a large muscle that helps to shape not only the lower face, but also heavily influences our neck musculature. It results in the depression of the lower jaw, displaces the lower lip inferiorly, and allows for an expression of horror or fright.

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Conclusions

In conclusion, knowledge of the facial muscles is paramount in procedures affecting facial animation. We must understand the relationship of facial muscles and associated nerves and vessels as well as the relationship of muscles and planes throughout the face.

MauiDerm News Editor-Judy Seraphine

 

Zappin the Tats

Suzanne Kilmer, MD

At MauiDerm 2014, Dr Kilmer, an expert in lasers and light devices for dermatological procedures, discusses tattoo removal…

For tattoo removal, we generally use the visible spectrum of light.  Years ago, we used CO2 laser or salabrasion for tattoo removal. The use of the CW laser resulted in trans-epidemal loss of ink, significant thermal damage and frequent scarring. The newer Q-Switched Lasers shatters the ink into smaller particles then utilizes macrophages to remove the ink; there is some trans-epidermal loss, yet, there is rarely any scarring.

There are several issues to assess regarding tattoo removal. Pulse duration can be performed in either the nanosecond domain or more recently, the picosecond domain; the picosecond domain may be better for breaking up the ink and it is and may not be as wavelength dependent. Remember that longer wavelengths penetrate deeper and, very importantly, is the fact that the ink’s absorption determines the best wavelength. Fluence/spot size should also be considered. We want the largest spot size; however, we need sufficient fluence. Larger spot sizes allow deeper penetration of effective fluence as long as the laser has sufficient power. Regarding treatment intervals, six to eight weeks is generally the best timing. Of note, dark tattoos are much more easy to treat versus multiple colored tattoos. Green ink responds best to red light and red ink absorbs more in the green light.

Some of the side effects with tattoo removal include ink darkening, incomplete removal of ink, allergic reactions and infections.

Tattoo Treatment Improvements

Over 25 years ago, we went from long pulse to QS laser treatment. QS treatment demonstrated a dramatic improvement in ink reduction and side effect profile. This was the first time that we were able to remove tattoos without scarring. We started with 694nm then added 1064/532 and then 755nm wavelengths in order to improve color removal. This was performed for over 20 years with minimal improvement. In the last two years, we have shortened the pulse width to long pico/ultrashort nanosecond domain. Some studies demonstrated that multiple treatments in the same day increased ink clearance.

Picosecond lasers have a greater photoacoustic effect. In 2012, Cynosure came out with the first picosecond laser and it clearly demonstrated an increased clearance of ink when compared to the QS laser.

Picosecond lasers can also improve ink clearance in resistant tattoos with just two treatments when compared to QS lasers which showed no change over seven treatments.

Another company, Cutera, is looking at using other wavelengths with a novel picosecond laser. They are looking at a 1064nm with 532 component for picosecond domain.

Kossida & Anderson first reported faster tattoo clearing with single versus four treatments on the same day. After treatment, you should wait 20 minutes for whitening to clear “R20”. The photoacoustic effect and shattering of ink particles creates a cavity and as nitrogen gas flows in, you can see whitening. Nitrogen is slow to dissolve out (hence prolonged whitening). A study by Kilmer and Ibrahimi supported repetitive treatment on the same day in order to expedite tattoo clearance. They explored effectiveness of one versus two versus three versus four treatments (to alleviate scheduling nightmares.)  They found that two treatments were better than one but then they saw a declining efficacy with further treatment. Geronemus et al used an optical clearing agent, PFD, eliminating the 20-minute interval to clear whitening.

R20 Results-QS Laser

We have found that multiple treatments are better than single treatment on the same day for most tattoos. There is less of a difference between two, three and four treatments on the same day. Increased swelling may occur, as noted by patients and the treating nurse. There was no increase in pain; in fact, most patients felt less pain with subsequent treatment. We also saw no difference in PIPA and no scarring was noted. Generally, all patients preferred a more rapid tattoo clearance.

In summary, ultrashort pulse widths are better, but not always and multi pass is better, usually.

 

MauiDerm News Editor-Judy Seraphine

 

 

Introduction to Lasers and Light (And a Touch of RF and Microwave)

E.V. Ross, MD

Dr Ross, a leader in the field of laser and light therapy, provided the audience with an in-depth overview on lasers and light. Dr Ross begins by reminding us that we tend to look for the “easy” way out to make our patients look their best with the least downtime. In order to be efficient and effective for his patients, Dr Ross likes to have many lasers in one room; therefore, providing the best possible technology.

It is important that we really understand laser physics. You need to know some math, but it doesn’t have to be difficult math. You can take very complex mathematical relationships and break them down into very simple algebraic relationships. By doing so, you can actually apply your lasers and other technologies quite confidently. It’s imperative to understand how they work because if you don’t, you can get into trouble very fast. Remember to look, listen and feel….listen to the reaction, look at the laser, look at the patient at every pulse to be sure the endpoint is what you want to see because ultimately, the endpoint is more important than the physics.

When we talk about lasers, we need to know some basic definitions. One of the most important terms is fluence; fluence is simply the light dose, i.e., the amount of energy that we are investing per surface area for a particular application.  We used to speak a lot about power, e.g. 7 watts power or 12 watts power. Currently, we don’t talk much about power because most of our lasers today are pulsed lasers. What really matters are wavelength, fluence and pulse duration. Pulse Width is  very important, i.e., the time over which energy is delivered. Spot size, which contributes to the intensity inside the skin, is mainly important for visible light lasers and infrared lasers because a larger spot will penetrate better.

LASER, Light Amplification by the Stimulated Emission of Radiation, is a concept that Einstein predicted back in the 1920s, but it was not realized until May of 1960.

Why is laser different than a lot of other light sources? We can use a lot of non-laser light sources in dermatology and certainly achieve nice results. Intense pulsed light is a great example. There are some features of lasers that make them helpful for dermatology and helpful for certain applications, but not always necessary for every application.  (See http://www.colorado.edu/physics/2000/lasers/index.html)

Why is it important to differentiate laser light from non-laser light? Dr Ross explains that it is because of engineering more than anything else. Most of our targets that we treat in dermatology have multiple wavelengths as far as their absorption. Lasers are a convenient way to deliver light, i.e., deliver photons to the target. This is why lasers are so popular. You can put lasers into a fiber, you can have monochromatic light, and you can deliver very high power. It’s the only way to really deliver very short pulses in nanoseconds and picoseconds for certain applications.

Why do we need to know how/why lasers, etc. work?

Dr Ross states that one important reason is that when your laser breaks down, which can happen, you want to understand why it isn’t working. If you have a good understanding of how your laser works, you may be able to correctly diagnose that. If you see that your laser isn’t working right, often times there’s an error code. It’s important that you write down the code and report that to the technician. Sometimes it’s as simple as restarting the system.

You should be able to troubleshoot laser problems in a logical way…Device malfunction is one problem, an example is a temperature sensor malfunction. However, a bigger problem could be your lack of familiarity with the device; most laser problems are caused by the operator because they’re not familiar with how the device works—sometimes they are rented and sometimes they are only used once per week. Other factors that contribute to laser problems include poor patient selection, operational errors, poor post-treatment care, and simply bad luck.

Dr Ross reminds us that we have to think. Most of the time when we get into trouble with lasers it’s because we weren’t thinking—invest all of your brain power into that particular case while you’re performing the procedure and that means paying particular attention to endpoints.

Four years ago right before the Christmas holiday, Dr Ross had a typical case of a woman who came in for treatment of telangiectasias with a pulsed-dye laser. He used the pulsed-dye laser, 10mm spot, 7 J/cm2, and a 10-millisecond pulse and everything was looking fine. The patient developed some mild purpura and she was incredibly upset. So what happened? She didn’t have any blisters and everything else was fine. Dr Ross went back and looked at the beam profile and found that it was off by about 2mm (8mm instead of 10mm).  What had then happened was that the fiber was damaged so they were delivering the right energy but in a smaller spot; therefore, causing the fluence to become higher and the purpura threshold had become breached. The technicians then fixed the beam profile and there was no more purpura. Dr Ross reminds us that sometimes we may have to do some detective work to figure out what’s going on.

Broken mirrors can also compromise your laser experience.  Particularly with the CO2 laser, if your beam profile doesn’t look good it may be due to a broken mirror.

When your calibration doesn’t pass,  the most common reason is because of a bad lamp.

What we’re seeing now is a progressive change in laser technology. Lasers are becoming quieter, cooler, smaller, better and more reliable. We now have small, portable lasers (see figure 1) and maybe, in the near future, we’ll see small lasers that can treat everything from tattoos to resurfacing.

Screen Shot 2014-05-26 at 7.50.01 AM

Remember that with most of the lasers that we’re using today, the light piece is “back in the box” and is delivered through some sort of delivery system; however, in the case of some of the mini diode lasers, the light is in the hand piece. (See Figure 2)

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Over the next few years, we are also going to see more and more LEDs. We are going to begin to see more safety features that will be incorporated into the software with touchscreens. For example, you may have a patient who came in for treatment of a wart so the technician turns the dynamic cooling device off. Then, your next patient is coming for treatment of a port wine stain and the technician forgets to turn the DCD back on and the patient gets a blister from the very first pulse. What if there was a tool that provided a warning signal indicating that the DCD was off? Actually that feature is already built into one popular pulsed dye laser.

What about photon recycling? This is a way to capture some of the photons that were wasted. Whenever we use a laser much of the energy is reflected back off the skin surface. By recycling the energy we have a second chance to use those photons. This preserves energy and puts less stress on the system. We will also see more and more scanning technologies as they are becoming increasingly robust. In the future, we will probably see scanners that will find the target and treat it.

Another concept that Dr Ross discusses is the TRASER (Total Reflection Amplication of Spontaneous Emission of Radiation). The traser is not a laser, nor an IPL. This is one device with many wavelengths that is tunable, has high peak power and variable pulse duration. This device is actually less expensive than a laser and you can change the dye very quickly. The traser uses total internal reflection. We know that if we take light beyond a critical angle, the light will come back towards the same direction.

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Overall, with lasers in dermatology, you only have to know the chromophore spectra of three targets: blood, melanin, and water. If you know the relative absorption for specific wavelengths for these three targets, you will be a fairly well-armed laser surgeon.

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When you model a laser-tissue interaction, you want to look (in your mind) at the way that the light propagates through the skin to the target. You have to get the light to the target. Then, depending on the pulse duration and the wavelength you’re going to have a certain amount of temperature increase leading to a response from that target due to the temperature and time combination.

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What about skin optics? It’s important that you determine the penetration, the absorption and scattering, and the internal dosimetry.

Laser Tissue Interaction Types

There are different types of interactions. The main type that we use in dermatology is thermal, in that we are basically converting light into heat. Other types of interactions include mechanical, chemical, and plasma. Dr Ross feels that one of best ways to learn about laser tissue interaction is through laser hair reduction. The laser comes down, and a certain amount of the light is going to reach the hair bulb, based on the optical properties of the skin. Typically for 1064nm, about 30 percent of the light is going to get about 3mm down which is the typical depth for a hair follicle. Depending on the pulse width, the wavelength, and the fluence, you will have a certain temperature elevation of that hair bulb and some of that heat is going to diffuse to the surrounding skin. So long as the temperature and the time combination is relatively small, you won’t have too much collateral damage—you will only damage the hair follicle.

Selective photothermolysis was a formal termed coined by Dr Rox Anderson 32 years ago. What it says is that if you have the right wavelength, the right pulse duration,  the right target, and sufficient energy,  you will achieve extreme localized heating. This really revolutionized the way in which we treat vascular and pigmented lesions.

As a dermatologist, you should always remember the graph below, where the wavelength is on the X axis, and you have the relative chromophore absorption in the Y axis. If so, you will be a well-armed laser surgeon. Just like a neurologist looking at an EEG and a cardiologist looking at an EKG, this should be second nature to you.

Screen Shot 2014-05-26 at 7.59.36 AM

How can we exploit laser physics? An example of this is a scar. When we have a scar, there is usually some feature that makes it different from the surrounding skin. You can take a laser and exploit that, whether its redness or pigment in the scar.

This is the temperature equation that basically tells us how hot targets get…the temperature elevation of any target is proportional to the relative absorption of that target for that wavelength of light times the energy div over by a constant. This is very simple concept as its basically energy balanced. Where is the equation??

As you go to longer pulses, the selectivity of the heating becomes poorer but the violent nature of it becomes less.

Fat

Dr Ross states that we are still woefully poor at targeting fat, whether it’s radiofrequency or laser. There are a couple of wavelengths that can be useful for exploiting fat; 1210nm and 1720nm. Those are the wavelengths where fat absorption is in excess of water absorption. However, the ratio of absorption from fat to water is only 1.2 or 1.1 to 1. When we treat a vascular lesion, our absorption rate for the blood is more like 100 to one vs water. So relatively speaking, fat shows poor selectivity, but if you deliver heating and cooling right, there is some selectivity for fat absorption.

Other Key Points

With regards to cooling and heating, we always want to preserve the epidermis and a dynamic cooling device can do so. It is also important to know the photochemistry with regards to chemical reactions and pay attention to these reactions; an example of this can be seen with patients who have previously been on Gold.

Microwaves and Radiofrequency

Microwave and radiofrequency devices are becoming increasingly commonplace within our armamentarium. They rely on heating water, the resistance of water molecules turning causes heat. The  microwave device is around 6GHz. Problems like underarm sweat can be treated with systems like MiraDry. Basically what happens is that the microwaves come down and there is a discontinuity of the dermal-fat junction and it heats up the sweat glands about 4mm below the skin. MiraDry offers another application in clinical practice and can complement other procedures. It also has little downtime.

We are going to begin to see more and more radiofrequency (RF) reactions. It is important to understand SAR, i.e., the specific absorption rate at which energy is absorbed when exposed to an RF electric field. By delivering the right time and the right temperature, one can establish very nice reliable heating of the skin.

 

MauiDerm News Editor- Judy Seraphine

 

 

Clinical Pearls-Dermal Filler Complications

Wm. Philip Werschler, MD

It is important to keep in mind that complications can occur when using dermal fillers in clinical practice…It’s important that you:

  • Recognize complications and promptly treat them
  • Not hesitate to see patients in follow-up and refer them if necessary
  • Are truthful with your patients and stay in close contact with them

What about impending necrosis? Remember that impending necrosis as a proposed MOA and patient’s actions may have an impact on the development of impending necrosis…Dr Werschler provides us with some practice tips:

  • Educate staff on concept of impending necrosis
  • Educate and consent patients on risk of necrosis
    • “Scabbing, shedding, discoloration and shallow scarring which may result in prolonged healing and/or the need for reconstructive surgery may occur in rare instances”
  • When patients call and complain of increasing pain, discoloration, headache or other unusual symptoms, instruct staff to have pt. take a NSAID, discontinue cold/ice packs, and come to office for evaluation

 

Concern of an impending or acute necrosis is a clinical consideration and you should act immediately! Apply a warm compress, nitropaste, confirm NSAID use, and massage as the first step. You should then evaluate the response and consider the use of hyaluronidase and cover with antibiotic, also consider oral corticosteroids. If frank necrosis occurs, utilize HBO2. If necrosis has already occurred, HBO2 speeds tissue repair and healing. Be sure to consult plastic surgery early.