Conducting clinical trials is one way for a practice to collaborate in the development of new drugs and devices, according to speaker Kenneth Beer, M.D., at last year's Cosmetic Bootcamp. He is a West Palm Beach, Fla.-based dermatologist in private practice and a cofounder of CBC, as well as associate clinical professor of dermatology, University of Miami Miller School of Medicine; consulting associate, Department of Medicine, Duke University; and clinical associate in dermatology, University of Pennsylvania Perelman School of Medicine.

Clinical trials also can provide a great opportunity for patients to get treatments before they are in the mainstream, he says. And if a practice provides satisfactory treatment for patients recruited for an acne or atopic dermatitis study, says Dr. Beer, these patients likely will choose to stay with the practice after the study concludes.

In This Article

The Clinical Trial Set-up

What You Need to Know

Getting Your Foot in the Door

Tips for Trial Success

The Clinical Trial Set-up

In setting up a clinical-trials program, says Dr. Beer, it helps to have an interest in and affinity for this type of work. In his case, "I love to publish, travel and work with drug companies on next-generation products."

Ideally, he says, a practice's clinical-study business should have a separate location, corporate structure and staff. Alternatively, "Once you have staff, you can hire other physician investigators to diversify" before embarking on a free-standing clinical-trials practice.

Whichever route a practice chooses, says Dr. Beer, "It's very important that you have one full-time study coordinator." Fortunately, he says, one of his nurses was able to become his study coordinator. "But I don't recommend that approach. It's really hard. Find somebody who's interested in clinical trials. They may not be highly experienced," but this person must be familiar with good clinical practice and open to learning the clinical-trial ropes. In these areas, he suggests using resources such as online tutorials available from the National Institutes of Health, as well as journals, organizations and meetings devoted to clinical trials.

What You Need to Know

What You Need to Know

Along with good clinical practice, Dr. Beer says that physicians and their staff also must be familiar with informed consent, recruitment, budgeting, negotiating and space and staff requirements.

Ultimately, "You'll need to know a lot more. And you'll need more than one clinical-trial coordinator. If you're doing 12 studies, you'll probably need three coordinators."

Furthermore, "Sponsors will look to see if you're really serious about it" and have a dedicated location with its own staff. Conversely, "If your front desk girl does your clinical coordinating while running charts around and answering the phone, it doesn't look good."

Additionally, Dr. Beer says it's important to show sponsors that your staff is being continuously educated. "But at least up front, the educational requirements are manageable."

Often, he says, drug companies will initiate trials by approaching experienced investigators. If this happens, "You can pick and choose which ones you'll participate in. The downside is, you must toe the line. You can't create anything new" within the study protocol.

Travel to investigator meetings also is required, he says, as is hosting monitoring visits from sponsors and/or the Food and Drug Administration (FDA). "Sometimes the sponsors want face time. And every time a monitor comes in, even if it's for five minutes, you have to meet with them" and answer any questions they may have. "They open up your books; they want to see what you're doing."

Ultimately, "You have to figure out if it's worth the time and money."

Investigator-initiated trials, on the other hand, require one to generate an idea, such as a new use for a neuromodulator, and propose it to a company or other potential sponsor, says Dr. Beer. This process is difficult, he said, "because you must come up with 10 ideas for everyone that will be accepted."

Getting Your Foot in the Door

Getting Your Foot in the Door

Landing clinical trials of any type requires networking, he adds. To get started, "If you have a friend in another state who is looking for additional sites for a trial that sounds interesting, let that friend know you're interested." If one publishes in a particular area such as acne, lasers, neuromodulators or fillers, Dr. Beer suggests opening the dialogue with a potential sponsor by communicating your interest to the appropriate sales representative.

"It's a very long, arduous procedure. Nobody hands you anything. It's something you really must invest in. There's one company we have invited to our site three times a year — they've come probably once a year. I've still never done a study with them."

Tips for Trial Success

Tips for Trial Success

Of greater concern, he says, is that sloppiness and dishonesty in clinical trials can bring trouble from the FDA. In one such case, "A physician's assistant was doing trials and patient care at the same time and was found to be making up data. The FDA shut the site down."

Additionally, "Recruiting can be difficult." If your practice lacks a strong patient base and/or staff and fails to recruit the patients required for a study, says Dr. Beer, the sponsoring company will be disappointed because it will have spent money initiating your study site.

Above all, "Don't just do clinical trials for money. However, if you're interested in practice diversity, and it's the type of thing that intellectually fascinates you, it can be a good direction to take."

Disclosures:

Dr. Beer is the owner of ScientificRx Skincare. He has been a consultant and/or investigator for Allergan, Merz and Valeant, and virtually all makers of cosmeceuticals and in-office products. He also is a cofounder of The Cosmetic Bootcamp, which will begin offering a clinical trials boot camp for physicians of all specialties at a time and location to be determined in 2015.

A new study offers insight on how injections of onabotulinum toxin A may affect skin elasticity and pliability.

The researchers — James P. Bonaparte, M.D., of the Department of Otolaryngology-Head and Neck Surgery, University of Ottawa, and David Ellis, M.D., of the Division of Facial Plastic Surgery at the University of Toronto — undertook a prospective cohort study on the mechanism of action of botulinum type A on certain skin properties. “Understanding the natural course that onabotulinum toxin A has on the elasticity of skin may help physicians understand why there appears to be a progressive reduction in wrinkle levels with repeated treatments,” they write.

To determine whether onabotulinum toxin A increases skin pliability and elasticity with a corresponding decrease in the contribution of the viscoelastic component of skin resistance, Drs. Bonaparte and Ellis enrolled 48 onabotulinum toxin A-naïve women, with a mean age of 55 years, from October 1, 2012, through June 31, 2013. The participants, 43 of whom completed the study, had a minimum of mild wrinkle levels at the glabella and lateral orbit. Glabellas, supraorbits and lateral orbits were treated with onabotulinum toxin A and assessed at baseline, two weeks, two months, three months and four months post-injection.

For all three areas — the supraorbit, the glabella and the lateral orbit — there was a significant effect of time on pliability, elastic recoil and the ratio of viscoelastic to elastic distension (Uv/Ue ratio).

“This study provides further evidence that there is an alteration in biomechanical properties of the skin after injection with onabotulinum toxin A,” the authors write. “This effect appears to last up to four months in the glabella and up to three months at other sites. The decrease in the Uv/Ue ratio suggests onabotulinum toxin A injection does not result in an increase in tissue edema suggestive of an inflammatory reaction within the skin. However, it remains unclear whether this is due to an intrinsic property of the medication or another, unrecognized mechanism.”

The results are in from a Swiss study that attempts to quantify the extent to which a person’s exceedingly protruding ears might have an effect on how others perceive him or her.

According to researchers from the Department of Otorhinolaryngology–Head and Neck Surgery at Cantonal Hospital, St. Gallen, Switzerland, protruding ears often are considered a stigma that leads to negative effects, which in turn can indicate corrective aesthetic otoplasty in patients too young to give informed consent. However, they also point out that the negative effects purportedly caused by protruding ears have never been quantified.

In an effort to quantify the effect of protruding ears on the perception of selected personality traits, the researchers conducted an observational study from August 1, 2013, to October 31, 2013. They recorded the visual scan paths of 20 lay observers looking at photographs of faces of 20 young people, ranging in age from 5 to 19 years, with protruding ears or ears morphed via computer software to appear non-protruding. The observers rated 10 perceived personality traits based on the photographs.

What They Found

What They Found

The researchers compared and correlated observers’ visual-fixation time on protruding versus non-protruding ears with their scores for personality traits. The researchers found that fixation time on protruding ears was significantly longer compared with that for morphed non-protruding ears (9.6% versus 5.8%, respectively, of total fixation time. However, the difference between the overall personality questionnaire scores and individual scores for assiduousness, intelligence and likeability was not significant for protruding and non-protruding ears. Faces in which protruding ears received the highest percentage of visual attention scored higher than average for the overall personality scores and for assiduousness, intelligence and likeability as compared with the faces with non-protruding ears.

The verdict, write the study authors, is that “protruding ears had the potential to draw viewers’ attention but did not cause a negative perception of personality traits. This study, therefore, does not provide confirmatory evidence for the stigmatizing nature of protruding ears.”

The study appears in the May/June issue of JAMA Facial Plastic Surgery.

Researchers in China say they have created an innovative method for carrying out an upper-lip lift.

Because lips are a prominent facial feature that age along with the rest of the face, microsurgery for upper-lip lifts is gaining in popularity. One reason, write the authors, is the procedure’s minimal trauma and rapid recovery.

The five-member research team — all from the department of plastic surgery at Sun Yat-sen University, Huizhou, China — designed a study, the inclusion criteria for which required patients to:

• Have a significant distance between the labiale superius and stomion
• Have a 50 to 60 degree upper lip angle
• Be younger than 60 years of age
• Show preference for and request to undergo the procedure

From January 2009 to March 2013, 30 female patients underwent the procedure. The patients received local anesthesia for a regional block of the infraorbital nerve. Surgeons excised a T-shaped orbicularis oris and a strip of skin, sutured the superior edge of the orbicularis oris muscle to the base of the nose, and closed the incision with a continuous intradermal suture. Postoperative follow-up time ranged from 1 to 5 years.

Their Lip-Lift Results

Their Lip-Lift Results

The researchers report that the incisional scar was not visible at follow-up. The nasolabial angle averaged about 96 degrees before the procedure and just over 88 degrees after, a statistically significant difference. The upper lip angle was about 65 degrees before surgery and about 52 degrees after, also a statistically significant difference.

Three of the 30 patients experienced redness and swelling of the incision 2 to 3 days after surgery, but none experienced dehiscence, bleeding or hematoma in the postoperative early phase. Most patients had scarring early on, but the scars had disappeared 2 to 3 months after surgery. Two patients had incisional scarring at the time of long-term follow-up; these patients underwent scar-revision surgery and postoperative treatment to prevent further scarring. The authors report no other complications.

“Our T-shaped excision of the orbicularis oris muscle was characteristically different from the other reported methods,” the authors write. “By excising the muscle vertically and not excising the surface skin, we projected the philtrum, causing the philtral groove to become visible. Though our ability to elevate the corners of the mouth was limited, decreasing the upper angle diminished the effect of aging. Because of our innovative technique and the quality of the sutures, no serious complications occurred.”

The study was published in Aesthetic Surgery Journal. 

According to a new study, Botox is still the best product for correcting upper-face wrinkles — but not by much — when compared with the new kid on the botulinum block.

Two Florida plastic surgeons have completed a study comparing the newest FDA-approved botulinum toxin type A product, incobotulinumtoxinA (Xeomin, Merz) with longtime leader onabotulinumtoxinA (Botox, Allergan) on performance in correcting upper-face wrinkles.

According to the authors — Ruth Hill Yeilding, M.D., Winter Park, and John P. Fezza, M.D., Sarasota — this is the first prospective, split-face, randomized, double-blind study to address three types of facial wrinkles — glabellar lines, crow’s feet and forehead lines — using a 1:1-dose ratio.

The study enrolled 45 subjects, 41 of whom were women. Ages ranged from 26 to 82. A three-judge independent review panel compared photographs of patients with the upper-face validated assessment scales and selected a grade ranging from 0 (no lines) to 4 (very severe) for each side of the face before treatment and 3 days, 2 weeks, 3 months and 4 months after treatment. For toxin comparison, the researchers calculated differences in the degree of wrinkle scale at each period compared with pre-treatment and performed statistical analyses. They analyzed wrinkle types both individually and combined.

In the randomization, onabotulinumtoxinA was used on the right side of 22 patient faces and on the left side in the remaining 23. The contralateral side was given incobotulinumtoxinA. Glabella dosage was 20 units, consistent with FDA guidelines for both toxins. Since there were no FDA guidelines for forehead lines or crow’s feet at the time of the study’s design, the authors used 10 and 15 units, respectively, based on their experience, prior studies and peer discussion.

“For identical dosage, both onabotulinumtoxinA and incobotulinumtoxinA are safe and effective in the treatment of glabellar lines, crow’s feet lines and forehead lines,” the authors write. “However, for our dosage levels, onabotulinumtoxinA was statistically greater in combined dynamic wrinkle reduction at 3 days, 2 weeks, 3 months and 4 months.”

Dr. Yeilding tells Cosmetic Surgery Times that dosage was the determining factor.

“Our choice of study dosage levels was on the low side, at 50 units for three areas, and therefore reduced the influence of product saturation,” she says. “We believe this contributes to being able to see differences between products. This is the first split-face study showing statistically significant difference in efficacy between neuromodulators.”

The study appears in the May issue of Plastic and Reconstructive Surgery.

http://journals.lww.com/plasreconsurg/Fulltext/2015/05000/A_Prospective,_Split_Face,_Randomized,.10.aspx

Results of a study by a team of French researchers suggest that autologous fat grafting (AFG) may be a viable alternative to surgery for breast augmentation.

The authors undertook a systematic review of relevant literature on the topic to determine the worldwide status of fat grafting for aesthetic breast augmentation. They reviewed 42 articles and studies that were published between January 1987 and July 2014 in North America, Europe and Asia. They found that most of the studies had a low level of evidence, with only one level 2 investigation, a prospective cohort study that included 10 patients. They found that the indications were for aesthetic augmentation (92.4%) and congenital malformation (7.6%). Two cases of cancer were reported among the 2,023 patients included in the literature.

The review included all original articles concerning patients who had undergone AFG on native healthy breasts that were published during the designated time period. Reviews and studies on breast reconstruction after cancer were excluded.

The study authors note that AFG is the only potential alternative to surgical breast augmentation. As background, they point out that its use in breasts was forbidden by the American Society of Plastic Surgeons (ASPS) in 1987 due to “issues related to efficacy and safety.” Twenty years later, they explain, the ASPS Fat Graft Task Force was created to “assess the efficacy and safety of lipofilling in breast surgery and establish evidence-based recommendations in order to promote its use” and that AFG has been used on native breasts since 2009, when regulations on its use were implemented in the United States (and in France in 2011).

“AFG seems to be a major tool in this field, but we must remain cautious about its systematization for this indication,” the authors conclude. “Pre-operative patient selection is essential but under-reported. AFG appears particularly relevant in breast malformations. We believe that this method should be practiced within the scope of a national or international registry with proper follow-up of patients.”

The study appears in Aesthetic Surgery Journal.

Dr. Anthony BenedettoWhen performing facial rejuvenation treatments in cosmetic patients, it’s time to take a “whole face” approach using various cosmetic tools to achieve not only excellent aesthetic outcomes but also more natural-looking results in facial rejuvenation. That’s according to Anthony Benedetto, D.O., F.A.C.P., clinical professor, department of dermatology, University of Pennsylvania School of Medicine, and medical director of the Dermatologic SurgiCenter, Philadelphia. Dr. Benedetto spoke at the annual meeting of the North American Clinical Dermatologic Society in 2014.

“In order to more effectively modify the static changes, clinicians should approach the face as a whole and address all aspects of the aging face, and not only ‘fill’ the lines that one sees,” he says.

Related: Injection savvy: Using anatomy to your advantage

The static changes that occur over time in the aging face involve varying degrees of volume loss, including skin atrophy and reduced elasticity, fat atrophy and decent into the lower face, as well as muscle, soft tissue and bone mass loss. In addition, the dynamic changes that occur are a result of chronic muscle movement in the face, which results in wrinkling of the overlying skin over time.

“Not only do we have to address the static changes, but we also need to understand the dynamic and interaction of the involved muscles and facial expressions in nonverbal communication to better treat the aging face as a whole,” Dr. Benedetto says.

In This Article

The Facial aging process

Filler Factors

Dr. Benedetto’s Filler Choices

The Facial aging process

The Facial Aging Process

Natural aging or intrinsic aging is a continuous process that normally begins during the third decade of life. During this process, Dr. Benedetto says collagen production slows within the skin and elastin has less “spring.” This, together with extrinsic aging, results in a three-dimensional aging process that not only involves a thinning of the epidermis and dermis, but also numerous other changes. These changes include:

• More prominent bony landmarks
• The indentation of periorbital areas and temples
• Diminishing support of the mid- and lower face
• Deepening and elongation of the nasolabial folds, creating marionette lines, which are enhanced by the decent of the corners of the mouth
• Enlargement of the jowls and pre-jowl sulcus
• Thinning and elongation of the lips
• Ptosis of the nasal tip
• Chin recession

The underlying fat compartments in the face are distinctly separated from each other by fibrous connective tissue, Dr. Benedetto says, and the shifting of the facial fat pads over time also significantly impacts and typically characterizes the aging face.

“In a young face, the boundaries between the compartments are not obvious but smooth in outline, and as we age, the cosmetic units become more obvious,” he says. “This is what enhances the bony appearance of the face after all the thinning and loss of soft tissue. However, the face does not age evenly because changes occur in different compartments at different rates or times as the patient ages, causing subtle changes over time, which slowly but surely define an older-looking face.”

Filler Factors

Filler Factors

While collagen was the preeminent cosmetic tool of its time in facial rejuvenation decades ago, continued research has borne numerous other dermal fillers composed of hyaluronic acid (HA), polylactic acid (PLA) and calcium hydroxylapatite (CaHA). Approximately 95% of dermal filler treatments today are performed in the mid- and lower face, Dr. Benedetto says, not just to fill wrinkle lines, but to replenish and recontour this region.

“Many of the state-of-the-art filler products available today can help us significantly modify and augment the aging face, allowing us to treat beyond the forehead and glabellar lines and nasolabial folds, such as the lateral brows and temples, the tear trough and the perioral area. We can now much more aesthetically define and augment lips, soften and elevate oral commissures, eliminate marionette lines and pre-jowl sulci, and even augment and sculpt the chin,” Dr. Benedetto says.

Numerous factors should be considered when choosing the appropriate filler for the different target regions of the face, he says, most important of which include the individual characteristics of a given filler product, such as its degree of crosslinking, concentration, gel hardness (G prime), cohesivity, viscosity and biologic effect.

“The longevity of effect as well as the distribution of the product underneath the skin are also important factors to consider when choosing the ideal filler for a given location. While the filler should be easy to inject, it should also be elastic but firm to the correction,” Dr. Benedetto says.

Dr. Benedetto’s Filler Choices

Dr. Benedetto’s Filler Choices

Depending on the patient and the correction to be made, CaHA-based products are Dr. Benedetto’s dermal filler of choice when filling and rejuvenating the lateral malar and malar area, submalar cheek, nasolabial folds, nasal defects, nasal tip, scars from acne or trauma, marionette lines, mental crease as well as augmentations of the chin and jawline.

Dr. Benedetto says he often chooses HA fillers for the correction of forehead and glabellar lines, lateral brow and temple, periorbital area including the tear trough, earlobes, radial lip lines, oral commissures, lip enhancement and horizontal necklines. He likes to reserve PLA filler treatment for the temple and malar areas, as well as in the nasolabial folds and jawline.

A Holistic Approach to Rejuvenation

A Holistic Approach to Rejuvenation

Each part of the face has a specific area where certain fillers are more appropriate. According to Dr. Benedetto, each filler has its place and should be chosen according to the target region of the face and the aesthetic correction and outcome you are trying to achieve. Creating the “perfect” face is in the eyes of the beholder, he says, and achieving good aesthetic outcomes depends on the physician and his or her sense of symmetry, proportion and balance.

“When enhancing and rejuvenating the upper face, some physicians may overlook the indentation often occurring in the temple area in elderly patients because they are too focused on filling lines and less focused on addressing the areas of volume loss,” he says. “When directly comparing the face of a younger and older patient, the indentation seen at the temple area is very obvious and the correction one performs with fillers there can be very dramatic.”

Dr. Benedetto says he combines different cosmetic tools when performing whole face rejuvenation, often starting with botulinum toxin injections to relax and redrape the targeted area, and then follow-up with filler treatments a few weeks later to replenish, reshape and recontour the region treated. If the patient requires or desires more, he may continue with laser skin resurfacing therapy for a complete whole face rejuvenation approach.

Performing maintenance treatments is also important for upholding results achieved at the culmination of the whole face rejuvenation treatment plan, Dr. Benedetto says. Not only will the intrinsic aging process continue, but the filler and botulinum toxin products injected will slowly degrade and wear off, requiring touch-up treatments.

“The three main areas to be addressed in rejuvenation of the aging face are the shape and position of the brows, the volume and shape of the lips and the texture of the skin, and the volume of the underlying subcutaneous compartment. A base knowledge of facial aesthetics, aging and anatomy will assist trained clinicians to adequately determine a course of treatment for the patient seeking aesthetic enhancement,” Dr. Benedetto says.

Disclosures

Dr. Benedetto reports no relevant financial interests.

Dr. Arthur Swift

Intravascular injections happen. But if you know your facial anatomy and attend to needle depth, it is possible to minimize these. That’s according to Arthur Swift, M.D., who presented an attentive audience with the intricate technical details of safe, effective facial injections at last year’s Cosmetic Bootcamp in Aspen. 

"If you understand the science behind the filler, know your injection anatomy and understand beauty and aging, you're going to use much less product than you have in the past," says Arthur Swift, M.D., a Montréal-based plastic surgeon. "This approach also maximizes results and minimizes intravascular issues. The face is teeming with blood vessels, so the idea of not piercing any one of them is ludicrous.  What is crucial is to make sure you are either above or behind the vessel and not inside it when you inject."

Related: Injection depth and botulium toxin for treatment of eyebrow asymmetry

In This Article:

Vital Anatomy

Anatomy of the Upper Face

The Temoral Region

Vital Anatomy

The shift from filling individual lines to performing deeper injections that contour and volumize requires injectors to exercise extreme caution, says Dr. Swift. "Whenever you're injecting under the skin, 'you're no longer in Kansas, Dorothy,' as I say. Now you're blindly encountering vital structures."

When an intravascular injection occurs, "As you put pressure on the plunger, you exceed systolic heart pressure — the product will disregard the direction of blood flow and seek the pathway of least resistance, which may be in a retrograde/proximal direction. Once you release the pressure on the syringe, the product will then flow with the blood antegrade. It is no longer where you've injected it, and it will flow forward clogging the distal arterioles." However, "If you skewer the vessel and inject behind it, you won’t deposit any product intravascularly —  it is intravascular embolization that causes the disastrous problems like visual loss."

When injecting near vital structures, "It is critical that you understand the depth of your needle tip. The anatomy in the face is too complex and varied to precisely know whether the artery is running slightly to the right or the left of where it is delineated in anatomy textbooks. But vessel depth in specific zones is fairly predictable, and if you appreciate the depth of your needle, you will minimize your risk of intravascular accidents."

In other words, said Dr. Swift, "I have coined the term injection anatomy to denote the study of regional anatomy as it relates to surface landmarks and the underlying depth of vital structures." He offers the example of an injection to the tear trough or nasal dorsum that cannulates the angular artery.

"If you catch the artery a little lower, say, towards the base of the nose, the product will most likely flow retrograde down the larger facial artery towards the mandible. When you release the pressure, the product flows antegrade with the blood and may actually embolize the inferior labial or superior labial artery. As a result, the threatened skin necrosis (livedo reticularis) is seen at the level of the lips, proximal to your injection point." If acted upon quickly, "This situation may be salvageable."

However, he says, "Injecting slightly higher into the angular artery or dorsal nasal artery may result in product flow in the other direction (towards the eye) if there is less resistance. Product then will flow backwards in the ophthalmic artery, and when you release the pressure, the central retinal artery may be embolized with resultant visual loss." Despite treatments including carbonic anhydrase inhibitors, hyperbaric oxygen and massive retrobulbar doses of hyaluronidase, says Dr. Swift, "We have not yet been able to reverse the blindness or ophthalmoplegia that may occur."

Anatomy of the Upper Face

Anatomy of the Upper Face

In the upper third of the face, he says, the supraorbital and supratrochlear arteries provide the main blood supply to the forehead. "It’s nice that we have surface landmarks or reference points, because we're not going to x-ray everybody to determine bony anatomy." With the patient looking forward, he suggests making a mark on the supraorbital rim that aligns with the medial iris. Beneath this mark, "You'll feel the supraorbital notch (when present). It's the most consistent finding in forehead anatomy, as studies have shown it to be within 1 mm of this point.  This is where the supraorbital artery will exit the skull as an extension of the ophthalmic artery inside the orbit."

Location of the supratrochlear artery is more variable, appearing 8 mm to 12 mm medial to the location of the supraorbital artery, Dr. Swift says. To find the supratrochlear artery, he recommends having the patient frown. "The most medial frown line overlies the supratrochlear artery as verified by Doppler studies. Interestingly, there is also literature that notes in 3 or 4% of patients, the supratrochlear artery emerging with the supraorbital through the supraorbital notch or foramen." The most medial frown line may have to be recreated by pushing with one's thumb in patients who have had neuromodulator treatments for glabellar frown lines, he adds.

Like the supraorbital artery, says Dr. Swift, the supratrochlear emerges from its deep location at the supraorbital rim to supply the skin, soft tissue, muscle and pericranium of the forehead. Both these vessels head north, branching in virtually any direction, he says.

"We have no clue of their exact path in the forehead other than their depth in specific zones. Within the first 1.5 cm, those arteries will perforate through the galea, which is the deep fascia on the undersurface of the frontalis muscle. They run cephalad either on the galea or inside the muscle, making their way to the muscle surface, to ride underneath the anterior frontalis fascia overlying the muscle.  Therefore, it would seem extremely hazardous to inject under the skin with a needle" within 1.5 cm vertical to the supraorbital rim in the region of these arteries.

Conversely, he says that the area that extends vertically cephalad from this zone, and horizontally to either temporal fusion line, is relatively avascular, as there are no vessels lying on bone, except for a small periosteal branch of the supratrochelar artery. "If you're going to inject for contour in the mid to upper forehead, you must stay on bone. The worst that could happen is that you might inadvertently skewer an artery and inject behind it, but the galea will protect the vessel and splay the product across the bone, which is exactly what we want.  This is using anatomy to disperse the product to your advantage."

Additionally, Dr. Swift cautions that the deep branch of the supraorbital nerve doesn't follow its superficial counterparts because it must supply the scalp and back of the head. "So it runs consistently 1 to 1.5 cm medial to the temporal fusion line, which you can feel. You don’t want to hurt the patient, so if you know the nerve is lying on periosteum in this area, and there is volume loss, insert the needle more medially and push the product laterally over the nerve."

The Temporal Region

The Temporal Region

In the temporal region, "The temporal fossa houses the temporalis muscle. As a muscle of mastication, superiorly it is stuck to the underlying bone in order to have a good purchase as it pulls up on the condyle of the mandible. It's more of a rudimentary muscle of mastication that was more necessary when we were swinging from trees because we had to bite for defense. You cannot inject under this muscle high up in the fossa because it is so adherent to the underlying bone."  Therefore, he says, injecting on bone one cm below the palpable temporal fusion line would actually mean injecting intramuscularly.

Regarding the vessels in this area, says Dr. Swift, the transverse frontal branch of the superficial temporal artery runs in the sleeves of the superficial temporal fascia on the deep temporal fascia (which is a continuation of the galea of the forehead), along with a plexus of veins.

Therefore, "My injection technique for temples is very simple — I inject 1 cm up from the lateral orbital rim and 1 cm lateral to the temporal fusion line, high up in the thinner fibers of the temporalis muscle. The depth here is maybe 4 mm before you hit bone. Again, you must make sure you are on bone — the worst that will happen is that you skewer an artery or vein that you couldn’t palpate. On the temporal bone in this region there are really no vessels of concern, as the terminations of the deep temporal arteries (anterior and posterior) are very small and more posterior."

He also advises keeping a finger above the injection point while injecting so that the product doesn't diffuse posteriorly under the hair-bearing scalp. "It's rare that I have to use more than 0.5 cc of appropriate product here —   I choose a higher G prime product, as it will try to lift and hit the undersurface of the deep temporal fascia, spreading between it and the muscle, creating a type of tent pole and overlying canopy. You can actually see the product flowing down towards the zygoma."

Dr. Swift reports no relevant disclosures.

Using a lidocaine mix with hyaluronic acid (HA) fillers to help mitigate pain is not an uncommon practice. But can adding epinephrine to lidocaine further offset bruising and pain?  

A research team led by facial plastic surgeon Amir Moradi, M.D., Vista, Calif., investigated the severity of bruising and pain in patients treated with the cohesive polydensified matrix HA (CPMHA; Belotero Balance; Merz) in three different preparations: CPMHA (BEL), CPMHA with lidocaine (BEL-L) and CPMHA with lidocaine and epinephrine (BEL-LE).

In a blinded, split-face, 14-day study, the research team divided 30 patients into three groups of 10. One group received 1 mL of BEL in the perioral lines on one side and 1 mL of BEL-LE on the other. A second group received 1 mL of BEL on one side and 1 mL of BEL-L on the other. The third group received 1 mL of BEL-L on one side and 1 mL of BEL-LE on the other. Over three visits, the treating investigator, the patients and a blinded investigator rated the bruising.

Study Results

Study Results

The findings show that patients in each group experienced bruising on the first day but that it resolved for half the patients by the seventh day and for all by day 14. Split-face comparison revealed no significant difference in pain and bruising scores among the patients treated with the three preparations.

“Studies with a considerably larger sample size are warranted to determine statistically significant and clinically meaningful differences between and among the various formulations,” the authors write.

The study was published April 23, 2015, online in the Aesthetic Surgery Journal.

According to a recent announcement by the American Academy of Cosmetic Surgery (AACS), its Facial Fellowship Program is back in a strategic effort to allow qualified fellow candidates to sit for the Facial Cosmetic Board Exam through The American Board of Facial Cosmetic Surgery (ABFCS).

“These facial fellowship programs are a tremendous asset to any professional in the specialty of cosmetic surgery, educating qualified surgeons through comprehensive hands-on training in cosmetic procedures,” says AACS President Dr. Michael J. Will.  “We couldn’t be more excited to bring these important programs back to our membership.”

As a result, the AACS is actively seeking out qualified fellowship directors. Candidates must be a Diplomate of the American Board of Cosmetic Surgery and a Fellow of the AACS.

For more information and specific fellowship director criteria: http://www.cosmeticsurgery.org/?page=FellowshipCriteria