Beauty and the Signature Feature™

Ava Shamban, MD

Dr Shamban is a renowned dermatologist and recognized as a skin care expert. In this presentation, she discusses the concept of beauty and how, as dermatologists, we can improve the aesthetic outcomes for patients by recognizing their Signature Feature™, a concept developed by Dr Shamban.

Dr Shamban reminds us that beauty is an expression of sight, smell, and sound. We want to make beauty memorable and we experience beauty at every level of our brain. Unfortunately, the media is always sending us messages about what we “should” like and this isn’t realistic. It’s important to remember that beauty can really affect one’s self-esteem. Lifestyle issues, such as stress, poor nutrition, diet, alcohol, and sleep can also affect beauty.

We now have a redefinition of aging and that has led to heightened expectations, i.e., what is normal and what is expected with regards to aging.  Dr Shamban also reminds us that reaction to beauty is hard-wired, in that “we know it when we see it.”

We have to remember what makes faces and bodies beautiful…


  • Symmetry
  • Proportion
  • Averageness
  • Defined contour


  • Smoothed draping
  • Texture
  • Pigment

Another concept that Dr Shamban discusses is that of the positive feedback loop. How we feel affects how we look and it’s a circular concept.

The purpose of aesthetics is to highlight the natural beauty of the individual. Dr Shamban’s  Signature Feature™ is comprised of three points:

  1.  Feature the particularly beautiful feature of the individual
  2. Persona-the signature feature should be tied to who that person is
  3. Showcase/highlight the signature feature

The goal of cosmetic work is to showcase the signature feature by reducing background noise, which in dermatology is composed of fine lines, wrinkles, textural changes, and brown spots. A blink-test will easily identify the positive feature on a person. As dermatologists, we need to remember that beauty is very important to our patients and we need to use insight and intuition along with the guides and tools that are available in order to help our patients look their best.


10 Most Important Take Home Points: Psoriatic Arthritis

Arthur Kavanaugh, MD

Dr Kavanaugh, a renowned Rheumatologist, provides the ten most important take home points in psoriatic arthritis to help practicing dermatologists…

  1. Psoriatic Arthritis (PsA) is common, occurring in about 20-30% of patients who have skin psoriasis. Patients almost always have psoriasis before developing PsA, sometimes by a decade or more. At present, we are unable to predict which psoriasis patients will go on to develop PsA.
  2. PsA is under-recognized, under-diagnosed and under treated. With more treatment options available, it is likely more PsA patients will be seen in the clinic and we will have more options for treating them.
  3. There is no single screening test or set of questions for determining which psoriasis patients have PsA. Sometimes it is hard for rheumatologists to tell. It is hardest for people with less abundant joint involvement (oligoarticular), and hardest to differentiate PsA from osteoarthritis (which can be inflammatory). Highly sensitive imaging techniques such as musculoskeletal ultrasound are sometime used.
  4.  Important areas of potential involvement for PsA, in addition to the skin and nails, include: 1) peripheral joints (e.g. small joints of the hands and feet,  of the wrists and ankles, the  knees, etc); 2) spine arthritis (essentially ankylosing spondylitis [AS] in a PsA patient),  3) enthesitis (inflammation of the insertion of tendons and ligaments into bone) and 4) dactylitis (swelling of an entire digit) Treatment depends upon the activity in these different areas.
  5. Greater understanding of the immunopathophysiology of PsA has led to the introduction of novel therapies, particularly TNF inhibitors . TNF inhibitors are the “go-to” biologic in PsA, and are sometimes used even before DMARDs.
  6. TNF inhibitors can be effective for all manifestations of PsA, although not all patients respond. Factors that affect response include obesity, which decreases the severity of disease as well as attenuates the response to treatment. Potentially tapering drugs, particularly biologics, is an area of increasing interest in rheumatology.
  7. Biosimilar TNF inhibitors have been approved in several countries worldwide, and a biosimilar infliximab received a favorable review from the European Medicinal Agency (EMA) and is almost certain to be introduced in European countries this year. Although the biosimilar was studies in RA and AS, it is likely to receive the full approval that the originator infliximab has, including psoriasis and PsA.
  8. Switching of TNF inhibitors can be effective in PsA. Many rheumatologists believe, although it is not proven, that TNF inhibitors and methotrexate offer synergistic benefit in PsA.
  9. Newer therapies for diseases like PsA, such as IL-12/23 inhibitors and IL-17 inhibitors, have been effective for some patients and are helping to define a novel approach to autoimmunity. Different than for the TNF inhibitors, autoimmune diseases seem to have varied responses to these other specific agents.
  10. Other new agents for PsA include oral inhibitors such as apremilast (a PDE4 inhibitor). The seemingly very good safety profile of apremilast has attracted particular attention.


10 Clinical Pearls in Psoriasis

Bruce Strober, MD, PhD

Dr Strober, an expert in psoriasis, provides 10 clinical pearls from the psoriasis presentations presented at MauiDerm 2014.

  1. Psoriasis is associated with chronic kidney disease.
  2. Psoriasis is associated with 5-yr reduced life-expectancy.
  3. Psoriasis is more highly associated with diabetes risk than is rheumatoid arthritis.
  4. IL-17 inhibition is associated with very high efficacy.
  5. Ustekinumab is an IL-12/23 inhibitor that has some efficacy in psoriatic arthritis, but not as high an efficacy that is displayed by TNF-inhibitors.
  6. Apremilast is a PDE4 inhibitor that has efficacy in both psoriasis and psoriatic arthritis.
  7. Calcipotriene and calcitriol when used in combination with topical corticosteroids may reduce the risk of cutaneous atrophy.
  8. Topical corticosteroids only rarely induce adrenal suppression, even if used on areas of high percutaneous absorption.
  9. Psoriatic arthritis is present in 20-30% of psoriasis patients.
  10. Concomitant methotrexate reduces the immunogenicity and augments the efficacy of biologic therapies for psoriasis.


Applying Laboratory Breakthroughs to Treat Pediatric Skin Diseases

Amy Paller, MS, MD

Our great progress in understanding the underlying basis for immune-mediated and genetic diseases has led to breakthroughs in therapy beyond prenatal and preimplantation diagnosis. Newer technology, ranging from next-generation sequencing to microarrays to proteomics, has facilitated these breakthroughs. Gene replacement through skin grafts has been initiated for treating recessive dystrophic epidermolysis bullosa based on early mouse studies and our knowledge of the deficiency of collagen VII and stem cell therapy to replenish cells with collagen VII- or laminin 332-producing skin cells at wounds has been modified to decrease risk and increase efficiency.

The availability of technology to create induced pluripotent stem cells and direct their differentiation into skin cells means designable sources of both stem cells and skin cells for grafts. New technology, such as use of microneedles or topically applied interfering RNA, is being studied as well to suppress the abnormal protein product and correct dominant-negative skin disorders, such as epidermolysis bullosa simplex and dominant dystrophic epidermolysis bullosa. Laboratory-based technology has also delineated the alterations in RNA and protein expression that define cutaneous immune-mediated disorders and tumors.

By understanding pathways that are activated, new therapy has been developed to target specifically these pathways and suppress the overactive immune system or growth and survival pathways. Recognition of the key roles of TNF, IL-23, and IL-17 in psoriasis has revolutionized our intervention through the development of targeted biologics.  The promising ongoing trials of IL-4 receptor antagonist and other blockers of Th2/Th22 pathways suggest that severe atopic dermatitis will similarly be treated with effective biologics. Already small molecules that target the activated signaling pathways in basal cell carcinomas (vismodegib), neurofibromatosis (imatinib for mast cells), and tuberous sclerosis (rapamycin) have suppressed tumor growth. Rapamycin is currently being applied to other disorders in which Akt/mTOR signaling is activated, such as venous malformations and could be considered for the subset of epidermal nevi with Akt pathway activation.

The other pathway leading to growth is the MAP kinase pathway, including through Ras and Raf activation. While a classic example of successful pathway suppression includes vemurafenib for Braf activation/ the Braf V600E mutation in melanoma, this MAP kinase pathway also plays a role in pediatric skin disorders of keratinocytes  (e.g., epidermal nevi), melanocytes (e.g., several forms of pigmented nevi), and endothelial cells (e.g., portwine stains). Finally, protein or lipid replacement therapy is an option used for several noncutaneous genetic disorders and is finding its way to dermatology. Injected recombinant collagen VII protein is now in trials for adults with recessive dystrophic EB and the combination of a statin to suppress the accumulation of cholesterol pathway precursors and cholesterol to replete the deficiency from pathway blockade has been used topically to reverse the skin changes of CHILD syndrome (Congenital Hemidysplasia with Ichthyosis and Limb Defects), which results from an enzyme deficiency in cholesterol biosynthesis.

These examples are just the beginning of what laboratory breakthroughs can yield for our patients. The next frontier is epigenetics and scientists are now unraveling the mechanisms that control cell- and tissue-specific gene expression. We can only imagine what scientists will discover in the future to transform medicine through personalized mutation-based gene and pharmacologic therapy.


Top 10 Topics in Vasculitis from a Rheumatologist’s Perspective

Arthur Kavanaugh, MD

Dr Kavanaugh, a leading Rheumatologist, provides us with the top ten topics in vasculitis from his perspective.

  1. There has been substantial change in the nomenclature for systemic vasculitides. Wegener’s granulomatosis is now being called GPA (granulomatosis with polyangiitis) and Churg Strauss syndrome is now being called EGPA (eosinophilic granulomatosis with polyangiitis). The 3rd similar systemic vasculitis is microscopic polyangiitis (MPA), which is distinct from polyarteritis nodosa (PAN).
  2. GPA, EGPA and PAN are sometimes known as ANCA associated vasculitides because of their potential association with anti-neutrophil cytoplasmic antibodies (ANCA).
  3. In addition to vessel size and ANCA, other factors relevant for vasculitides include the extent of involvement (limited vs diffuse) and the response to treatment.
  4. Systemic Vasculitis can have diverse manifestations. The skin is involved in approximately 40-65% of patients with GPA, EGPA, MPA and PAN.
  5. Internal organ involvement can be severe and serious and affect multiple organs. However, most areas of involvement will be apparent with only a directed history and physical examination, and a few straightforward laboratory tests and imaging procedures.
  6. ANCA testing can be of value, but results MUST be interpreted in the correct clinical context. The quality of the lab is very important.
  7. ANCA testing should not be relied upon as a predictor of disease activity for individual patients.
  8. Treatment options for systemic vasculitides include methotrexate for many more limited disease manifestations, and cyclophosphamide for more severe disease. Treatment often must be continued to prevent relapses.
  9. Rituximab has gained increasing attention as an effective therapy for severe systemic vasculitis.
  10. There are mimics of vasculitis that clinicians should be aware of.

New Drugs: 2014

Neal Bhatia, MD

Ted Rosen, MD

In this presentation, Drs Bhatia and Rosen bring us the latest information on drugs that are, or will be available to the practicing dermatologist.

Apremilast is an inhibitor of PDE4 and is currently in phase III trials for ankylosing spondylitis, psoriasis, and psoriatic arthritis along with orphan status for Bechet’s disease. A published case report for apremilast for lichen planus (Paul et al. JAAD, 2013) demonstrated that 30 percent of the patients experienced a 2-grade improvement. This study was, however, small in numbers, treatment time and dosages.

As Dr Tsao mentioned in his presentation, omalimuzab has demonstrated promising results for the treatment of chronic idiopathic urticaria.

Dr Bhatia commented on the new treatments for onychomycosis, and feels that we have a “flood year of antifungals this year.” What we need to know:

  • Naftifine 2% gel—tape strips show stratum corneum residual after 4 weeks
  • Luliconazole is approved
  • Efinaconazole and Tavaborole are not
  • Itraconazole 200 mg tablets with new dosing protocol
  • Ketoconazole gel (Xolegel) and Itraconazole tablets (Onmel) are back
  • Econazole Foam is coming

In a Phase II study of luliconazole cream 1 percent for the treatment of interdigital tinea pedis, the researchers found that complete clearance was 26.8 percent and 45.7 percent in subjects in the two-week and four-week treatment group, two weeks post-treatment. Four weeks post-treatment complete clearance rates were 53.7 percent and 62.9 percent, respectively. A phase II study of efinaconazole for toenail onychomycosis also demonstrated favorable efficacy. Tavaborole, representing a new class of anti-fungals, met all primary and secondary endpoints in the treatment of nail fungus when compared to ciclopirox lacquer.

Ketoconazole gel 2 percent has the same side effect precautions as oral products, on label, but these are doubtful. It’s important to remember that the brand name in some markets may be cheaper than the generic. Also of importance, rates of mycological cure and effective treatment (secondary efficacy endpoints) were observed in the Econazole Nitrate Foam 1% group relative to the Foam Vehicle in both phase 3 studies (P<0.001). Itraconazole (200 mg) (OMNEL)  is available with a new dosing protocol. In a study, 200 mg tablets were found to be noninferior to itraconazole 100-mg capsules at 52 weeks. The safety profile of Omnel is not statiscially different from that of itraconazole.

Dr Rosen began his section of this presentation discussing Pliagils (Lidocaine 7% + Tetracaine 7% Cream). Pliaglis is a topical, local analgesia for superficial dermatological procedures. It is applied 20-30 minutes for most minor procedures and 60 minutes for more major procedures and is available in 30,60 and100gm tubes.

Sitavig (acyclovir 50mg Buccal) is indicated for recurrent oro-labial HSV. The technology is a natural polymer derived from milk which adheres to the mucosa; therefore leading to high local drug concentration, but minimal blood levels. It is one tabe, applied within one hour of prodrome onset and reduces the duration of an attack by 0.5 days based upon a randomized controlled trial of 775 patients. Another advancement includes the approval of carbinoxamine maleate susp (Karbinal ER), which is a mildly sedating H1 antihistamine in an extended release formulation. It is used for the treatment of allergic rhinitis and conjunctivitis, uncomplicated urticaria, angioedema, and dermatographism. Aurstat Anti-itch hydrogel was also approved in early 2013 to treat the symptoms of atopic dermatitis and various dermatoses.

Old Drugs, New News:

  • Adapalene/BPO 1.2%/2.5% (Epiduo®)
    • Now FDA approved down to age 9
  • Desoximetasone 0.25% (Topicort®)
    • Now available as a spray
  • Ketoconazole 200mg tab (Nizoral®)
    • Severe limitations on use due to liver and adrenal toxicity, as well as drug interactions
  • Certolizumab pegol (Cimzia®)
    • Now approved for psoriatic arthritis

In conclusion, clinicians should pay special attention to the Nizoral FDA warnings published in July of 2013. ( If you use it and there is any hepatotoxic event, that could cause a great problem as a practitioner.

In summary, the dermatology landscape is continuing to grow with promising new drugs and it is imperative to stay on top of the latest data.


Acne: Part 2: Pediatric Acne

Larry Eichenfield, MD

Remember that acne can be categorized by age, i.e., neonatal (0-6wk), infantile (0-1), mid-childhood (1-7), preadolescent (7-12), and adolescent (12-19). Dr Eichenfield emphasizes that for dermatologists, mid-childhood (age 2 – 7) acne is the most worrisome. It can be associated with premature adrenarche, Cushings Syndrome, CAH, gonadal/adrenal tumors, and precocious puberty. Mid-child acne is very uncommon and dermatologists may want to consider a referral to an endocrinologist. The evaluation for mid-childhood acne includes testicular size (males), hirsutism, clitoromegaly, androgenetic alopecia, increased muscle mass, and deepening of the voice (males).  If the acne is persistent, severe, or virilizing, tests/examinations include a growth chart, evaluation including bone age, tanner stage, Total/Free testosterone, DHEAS, androstenedione, LH, FSH, prolactin, and 17OH-progesterone.

What do the new guidelines say?

These guidelines were developed by the American Acne and Roseacea Society and endorsed by the American Academy of Pediatrics, which is the first time that the Academy has a set of guidelines for the management of acne. One of the main reasons this was done was to address the gap between pediatric dermatologists and pediatricians. It’s important to know that pre-adolescent (7 ≤ 12 years) acne is common and may precede other signs of pubertal maturation. Work-up beyond history and physical is generally unnecessary unless there are signs of androgen excess, polycystic ovarian syndrome, or other systemic abnormalities. There is evidence that acne, and possibly puberty, are now occurring at an increasingly earlier age.

A recent analysis of the National Ambulatory Medical Care Survey (NAMCS) database assessed trends in the age of children seeking treatment for acne. NAMCS data from 1979 through 2007 were analyzed for all physician visits in which acne vulgaris was listed as a diagnosis in children aged 6 to 18. The analysis revealed a significant decrease in the mean age of children seeking treatment for acne over this period.

Over the past several years, clinicians have noted an earlier onset of acne—that is, the appearance of acne in patients as young as 8 or 9 years. Indeed, it has been suggested that 12 years of age should no longer be considered the low end of the “normal” range for the onset of acne.

Acne may be the first sign of the onset of puberty in children aged 7 to 11 years. The general clinical impression of earlier puberty is, in fact, supported by epidemiologic data in the US and elsewhere. In general, the trend toward earlier puberty is stronger among girls than among boys. In any event, the earlier onset of acne has mirrored the downward trend in puberty timing.

Acne Guidelines: Highlights

Topical retinoids may be used as monotherapy or in combination products and in regimens of care for all types and severities of acne in children and adolescents of all ages. It is important to remember that topical antibiotics are not recommended as monotherapy and if a topical antibiotic treatment is to be used for more than a few weeks, topical benzoyl peroxide should be added, or used in combination products. The guidelines also suggest that fixed-dose combination topical therapies may be useful in regimens of care for all types and severities of acne. With regards to oral antibiotics, they are appropriate for moderate to severe inflammatory acne vulgaris at any age. Tetracycline derivatives should not be utilized in children 8 years of age and below. Second generation tetracyclines are sometimes preferred to tetracycline because of ease of use, fewer problems with absorption with food and minerals in vitamins and other supplements, and less frequent dosing. It’s very important that patients are educated and monitored for potential adverse events when utilizing oral antibiotics for acne. Combined oral contraceptives may also be useful as second-line therapy in regimens of care in pubertal females with moderate to severe acne; however, tobacco use and family history of thrombotic events should be assessed. Due to concerns about growth and bone density, many recommend withholding OCs for acne until one year after onset of menstruation. Isotretinoin is recommended for severe, scarring, and/or refractory acne in adolescents and may be utilized in younger patients. Remember that extensive counseling, particularly regarding the avoidance of pregnancy, as well as careful monitoring of potential side effects and toxicities, is recommended.



Dermatology Year in Review: 2013

Hensin Tsao, MD, PhD

In this first presentation at MauiDerm 2014, Dr Tsao, a leader in Dermatology, provides us with an update on the latest hot topics in the field.


Dr Tsao begins with a short case study of a 45 year old man who presents with:

  • SSM- 0.80mm/Clark level IV
  • Mitotic rate: 2 per mm2
  • Lymphovascular invasion
  • Ulcerated
  • TILs present

As a dermatologist, would you recommend a sentinel lymph node biopsy? According to Dr Tsao “there has been a shift in the utilization of sentinel lymph node biopsies.”  Han and colleagues conducted a study with a large data set of patients (N = 5,125) with sentinel lymph node biopsies and found that in patients with thin melanomas, thickness and ulceration are the most predictive features of a positive sentinel lymph node.  This report can be found in the Journal of Clinical Oncology.

Dr Tsao’s key takeaway messages:

  • Among thin melanomas, increasing thickness and ulceration most predictive of positive nodal status
    • Rate is still low (~5%) and survival high (91% positive)
    • MSLT-1 OS: 90% negative vs. 72% positive
    • Among patients with 0.75mm/ulcerated lesions, if knowing the difference between 91% and 98% 5-year survival is important, then SLNB is reasonable


A recent study from the New England Journal of Medicine looked at the use of penicillin for the prevention of recurrent leg cellulitis. The researchers found that   prophylactic penicillin (250 mg p.o. BID) reduced the risk of cellulitis recurrence by approximately 50 percent. The duration of the benefit; however, is still unknown. Future studies for penicillin-allergic patients and cost effectiveness need to be performed.

Kidney Transplant

A report by Verneuil and colleagues found that in kidney transplant patients, donor kidney cells have been found in squamous cell carcinoma. SCC arising in kidney transplant patients. In another report by Xiao and colleagues, who looked at 69 studies which reported 104 donor transmitted cancers, they found that renal cell cancer, melanoma, and lymphoma were the most common. The cancer was usually diagnosed within one year from transplantation. For most non-renal cancers, cancers are metastatic at the time of diagnosis. Additionally, immunosuppression is stopped in most instances.

What are Dr Tsao’s key takeaway points?

  • Although rare, secondary malignancies from kidney transplants have been reported
    • Provides biologic evidence of secondary metastases
    • Renal cell cancer, melanoma and lung cancers may be most common- could be reporting bias since they may most likely cause death
    • Recent malignancy is an absolute contraindication for organ donation

Remember that a solid metastases can create another metastases from a different host.

Basal Cell Carcinomas (BCCs)

According to a 2013 study by Erits and colleagues, topical imiquimod five times a week for six weeks exhibits the greatest efficacy against BCCs. This was a single-blind, non-inferiority, randomized controlled trial looking at photodynamic therapy (PDT) versus topical imiquimod versus topical fluorouracil for the treatment of superficial basal cell carcinoma. The researchers found that imiquimod appears to be superior to PDT in efficacy but also appears to be associated with more side effects and 5-FU was intermediate in terms of efficacy and side effects. Of note, the limitations of the study include short follow-up times (12 months) and lack of cost-effectiveness analysis.


Shirley and colleagues reported, in the New England Journal of Medicine, that an activating mosaic mutation in GNAQ (R183Q) is associated with anomalous skin and brain tissue in Sturge-Weber Syndrome. Its important to know that the variant is not as biochemically activating as the Q209 mutation observed in ocular melanoma. The R183Q variant occurs in 0.7 percent of the general population as a germline variant. Definitive proof of this mutation requires functional verificaton, e.g. model systems.

Spitz Tumors and Spitzoid Melanomas

Recently, Weisner and colleagues found that kinase fusions are frequent in Spitz tumors and spitzoid melanomas. We know that molecular diagnostics are continuing to advance and the paucity of point mutations that are identified in spitzoid neoplasms could be accounted for by gene translocations. Remember that pediatric tumors may be more susceptible to translocations while adult cancers may reflect accumulation of carcinogen-mediated point mutations. Kinase fusions offer new opportunities for treatment, though the market for metastatic spitzoid melanoma is small.


Let’s consider a 35 year-old woman who has had a three-year history of chronic urticaria. A 2013 study demonstrated that omalizumab reduces

Acne: Part 1

On Day two of MauiDerm 2014, our panel of experts in the field of Acne presented new insights and new data that may help the practicing dermatologist improve the overall outcomes of patients in their practice.

Isotretinoin Issues

Written by Judy Seraphine

Dr Guy Webster lead off the discussion by discussing some of the hot papers in acne in 2013 that help with either the understanding of acne or the treating of it. The first paper, published in JAMA Derm, discusses high dose isotretinoin and whether or not it is safe and effective. Traditionally, data demonstrated that the 120 mg/kg dose has a 20% relapse rate. One thing that we have figured out is that if someone has really bad acne as a child, they will most likely have a relapse later and likewise, patients who had really severe acne on isotretinoin will likely relapse. Two recent studies showed that the more accutane than we typically use may decrease the relapse rate. Another paper, a retrospective study, looked at patients on a really, really high dose isotretinoin versus those on high dose isotretinoin and the researchers found the really high dose had a lower relapse rate, but it was still somewhat high. As dermatologists, we have to consider that there may be a difference in how we define relapse and prospective head-to-head studies need to be done.

Another paper, published by Drs Webster and Leyden in the JAAD, looked at a new form of isotretinoin that doesn’t require a dietary adjustment. We have known for years that isotretinoin requires a fatty meal as there is decreased absorption on an empty stomach. Dr Webster feels that the most common cause of isotretinoin resistance is due to patients taking the drug on an empty stomach. Data exist demonstrating that high-fat meals enhance the absorption of the drug, yet this new form of isotretinoin may be a viable alternative with regards to dietary change and acne outcomes.

What about P. Acnes? Dermatologists should remember that there are many strains of P. Acnes that have subtle differences, but there was no difference in where they developed. A recent paper reported that they found two strains of P. Acnes. The type 1a strain of P. Acnes predominates in inflammatory acne lesions and 1b in non-inflammatory. Some strains are associated with inflammatory acne; however, this association is a trend and not an absolute.  The question is whether this is due to ecology or virulence? There are two possibilities: 1a is more pathogenic and can survive better in an inflamed mileu. It’s important to look at how strain 1a is different from strain 1b.

Toxins: What’s New, Are There Differences Among Toxins, and What We Have Learned

Michael H. Gold, MD

Dr. Gold spends a lot of his time in Asia and, in this presentation, he shares some of the knowledge that he has acquired overseas with regards to toxins. The neuromodulator market is huge and the global medical aesthetic market is expected to post growth of 10.8 percent per year from 2010 to 2015.

Screen Shot 2014-01-07 at 6.17.19 AM


Medical Insight, Inc. “Global Aesthetic Market IX Research Report April 2011”, “Facial Injectables Report July 2011” ,“EU Facial Injectables Report July 2011


As mentioned in Dr Cohen’s presentation, it is extremely important to remember that the goal, when using neuromodulators, is a natural and relaxed look for your patients.

Data on Neuromodulators

When looking at the Xeomin clinical trials, dermatologists should remember that responders at maximum frown at day 30 had to have an improvement of two points on a four-point Frown Wrinkle Scale (FWS) compared to baseline by both the investigator as well as the patient. Neither Botox nor Dysport required assessments by both parties. So while the data on the 2-point responders did not look quite as compelling, the numbers for the 1-point responders appeared good.

Mentor, which was purchased by Johnson & Johnson, has completed their clinical trials on a new botulinum toxin, PurTox.  Many are hopeful that J&J will submit this data to the FDA in which case we will see this product at some point in the future.  Of note, both Xeomin and PurTox are pure toxins. Whether that actually makes a big deal clinically, Dr Gold does not think so; however, it is a wonderful marketing point.

Medy-Tox , which was purchased by Allergan in 2013, is the company that developed a product called Neuronox. It is currently approved in South America and Korea for blepharospasm and tortilcollis.  Dr Gold and others feel that Neuronox will not come to the United States market anytime soon. A double-blind, multi-center trial of 173 patients compared Neuronox to Botox in patients with hemifacial spasm. The efficacy evaluation was similar between both groups. A recent clinical study demonstrated the proven efficacy and safety of Neuronox on glabellar frown lines.

Another Korean company, Hugel, makes Botulax. Dr Gold mentions that this company is at many of the meetings to which he goes and they claim to have the Korean version of an FDA approval.

ChinaTox is a product made by Lanzhou Biological Products Institute.  It is important to know that many of the other toxins are actually fake ones.  An open label study between Botox and ChinaTox looked at 785 patients with focal spasm and dystonia. They found that ChinaTox was less powerful than Botox; therefore, higher doses were required. There were also five cases of skin rashes seen in the ChinaTox group. ChinaTox is; however, cheaper than Botox. Of note, the strain of clostridium botulinum type A was donated from the University of Wisconsin to Dr Yinchun Wang. ChinaTox was approved in China in 1989 and by 2002 the drug has been exported to several foreign countries and is currently in Brazil for both clinical and cosmetic use. ChinaTox has several different names in other countries. This is important to keep in mind as you’re reading various pieces of literature.

  • Prosigne-Brasil
  • Redux-Peru
  • Lantox-Russia
  • Lanzox-Indonesia

ChinaTox demonstrates similar efficacy as far as other neuromodulators. In Asia, calf hypertrophy is an issue. ChinaTox has shown positive benefits when injected into the calf muscle.

In Russia, there is a toxin, Relatox, with the “Russian FDA-approval.” It was produced at the Federal State Unitary Enterprise Research-Division of Microgen of Russian Ministry of Health. It is available in two dosages, 50µ and 100µ. Relatox is indicated for blepharospasm, cervical dystonia, and facial wrinkle correction and is recommended only for adults. A published article claims that Relatox is comparable to other toxins.

A topical toxin has been developed by Revance using a proprietary platform that enables transcutaneous flux.  The first commercial applications will be topical BoNTA in lateral canthal lines and hyperhidrosis. The product is well tolerated and demonstrates up to 89 percent response rate. The median duration of effect is 113 days.

In the US, Myoscience is developing a hand-held medical device for the treatment of facial wrinkles. Essentially, the device uses cold-induced modulation of facial nerves. This has demonstrated promising results in difficult patients and is a new option for toxin-averse patients.

Clinical Pearls

Physicians should only use branded products that are FDA-approved in the US or CE marked in Europe, or products that have received regulatory approvals in your country. There have been instances in the US where non-approved Botox was used and patients ended up paralyzed in the hospital. Physicians are also subject to major sanctions, fines, loss of license, etc. There are many fake products out there….this important to keep in mind as there are serious issues involved with the use of unlicensed botulinum toxins.