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Archives Volume 9 | Issue 9

Editors

Letter to the Editor

Joshua A. Zeichner MD and Joel L. Cohen MD
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Original Articles

Correction of Atrophic Scars With Artefill: An Open-label Pilot Study

Rachel E. Epstein DO and James Spencer MD MS
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Background: Artefill®, a novel permanent filler approved by the U.S. Food and Drug Administration (FDA), has been used as an injectable implant for the correction of nasolabial folds. Fillers are considered a first line treatment for atrophic scars. Objective: The authors evaluated the degree of correction and subject satisfaction of correction of atrophic acne scar(s) after injection of Artefill. Methods: Fourteen qualified subjects participated in a single-center, open-label, pilot study. Atrophic acne scars were evaluated prior to injection. Subscision was performed, and then Artefill was injected into the scar. The degree of improvement was measured at weeks 2 and 4 and month 8. Subjects were asked to fill out a satisfaction survey at their eight-month visit. Results: Investigator ratings after eight months post procedure indicated that 96 percent of the atrophic acne scars showed some degree of improvement. There was no improvement in two out of a total of 57 scars evaluated. The majority of patients reported a moderate correction, correlating with a 51–75 percent improvement in their acne scars at eight months. No adverse events or side effects were noted. Conclusion: Artefill demonstrated to be both an efficacious and safe therapy for the treatment of atrophic acne scars.

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Current and Future Botulinum Neurotoxin Type A Preparations in Aesthetics: A Literature Review

Gerhard Sattler MD
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Botulinum neurotoxin type A (BTX-A) preparations are well established for cosmetic use. BTX-A inhibits the release of acetylcholine, resulting in temporary muscle paralysis, which has been utilized successfully to treat glabellar frown lines, periorbital wrinkles and other facial enhancement procedures. Two BTX-A products are approved for aesthetic procedures in the United States (U.S.) and Europe, and a next generation of preparations free from complexing proteins has recently been approved in Germany. Despite established efficacy profiles, concerns remain regarding the propensity for immunogenic reactions, which can lead to premature loss of effect and secondary therapy failure. NT 201 is a BTX-A preparation that is free from complexing proteins and is in the advanced stages of aesthetic development. Pivotal clinical studies in therapeutic indications demonstrate noneriority and comparable safety of NT 201 to another available BTX-A preparation. This article reviews the pharmacologic and clinical profiles of BTX-A preparations currently available and in development. Novel BTX-A preparations may offer advantages over existing products in terms of handling and immunogenicity.

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Histopathologic Identification of Dermal Filler Agents

Stephen E. Mercer MD PhD, Rebecca Kleinerman MD, Gary Goldenberg MD, Patrick O. Emanuel MD
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As reflected in the literature, the use of dermal filler agents has increased substantially over the last decade. Consequently, these agents are more frequently encountered on histopathologic examination. A variety of dermal fillers can be readily identified histopathologically, and the accurate identification of these agents is a critical task for dermatopathologists. Furthermore, a basic understanding of the histological features of fillers has relevance to dermatologists and dermatologic surgeons. The identification of filler substances may have important diagnostic, medico-legal and medical management considerations. This concise review aims to provide a pragmatic approach to distinguishing the agents most frequently encountered in routine practice and in the literature.

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Retrospective Review of 500 Patients Treated With AbobotulinumtoxinA

Oscar Hevia MD
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Background: Prior international clinical experience and domestic controlled clinical trials provide useful guidance for dosing of a new botulinum toxin type A, abobotulinumtoxinA. Nonetheless, aftermarket experience is paramount in providing confirmatory “real world” information on any recently introduced drug. This report describes the incorporation of abobotulinumtoxinA into an established clinical practice that previously only utilized onabotulinumtoxinA for facial rejuvenation Description: Retrospective review of 500 patients who received abobotulinumtoxinA injections. Results: A total of 736 abobotulinumtoxinA treatments were administered to 500 patients. The most common areas treated were corrugators, “crow’s feet,” frontalis, brow and platysma, respectively. A dose conversion ratio of 1:2.67 (onabotulinumtoxinA : abobotulinumtoxinA) was determined. The majority of adverse events were considered to be mild and self-limiting. There were three (0.6%) cases of ptosis. Conclusion: Since its recent approval by the U.S. Food and Drug Administration (FDA), experience with abobotulinumtoxinA is evolving. Utilizing a dose conversion ratio of 1:2.67 units (onabotulinumtoxinA: abobotulinumtoxinA) and the same injection techniques, one can safely and effectively incorporate this new neurotoxin into his or her practice.

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Formulation Composition of Botulinum Toxins in Clinical Use

Andy Pickett PhD and Karen Perrow PhD
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The use of botulinum toxin (BoNT) has now become the treatment of choice for a range of debilitating neuromuscular diseases and for aesthetic medicine. BoNT products are licensed as prescription-only medicines by the health authorities of each country in which they are approved. The authors describe here the current status with regard to BoNT formulations and detail more precisely what is in each product. These data have been presented previously, in a fragmented way, in papers that discuss characteristics of the BoNT products but not the formulations in detail. This information is essential for clinicians in order to enable informed decisions about which products they wish to use clinically. The authors have also examined developments that are either in progress or likely to occur, based on currently available information.

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Failure of Botulinum Toxin Treatment for Localized Vitiligo

Ghada A. BinSaif MD, Abdullah Al Samary MD, Saad Al Mohizea MD
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Background: It was found that acetylcholine concentration increased with a significantly reduced expression of acetylcholinesterase in vitiliginous patches that return to normal upon repigmentation. Objective: To evaluate the efficacy and safety of botulinum toxin A in patients with localized vitiligo. Methods: Ten patients were recruited. Eight patients had two or more focal vitiliginous patches. Two had segmental vitiligo. For each patient with focal vitiligo, one or two vitiliginous patches were treated. For each patient with segmental vitiligo, half of the lesion was treated. The untreated parts were used as a control. Botulinum toxin was injected. The response was analyzed at the initial visit, and then two weeks, two months and six months after therapy. Results: Thirteen vitiliginous patches were treated. Reassessment showed no evidence of repigmentation. Comparing treated versus untreated sides, no differences were found. No adverse effects were reported. Conclusion: Botulinum toxin is not effective in the treatment of localized vitiligo.

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The Effect of Lidocaine When Mixed with Large Gel Particle Hyaluronic Acid Filler on Tolerability and Longevity: A Six-month Trial

Mary P. Lupo MD FAAD, Glenda Swetman MD, William Waller MD
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Objectives: To determine if there is any effect on tolerance, adverse events or clinical outcome when lidocaine is added to large gel particle hyaluronic acid (LGP-HA). Materials and Methods: Single-centered, double-blinded, randomized, with-in patient trial, comparing patient comfort when receiving LGP-HA injections versus injections of LGP-HA mixed with lidocaine hydrochloride 2% (LGP-HA + L). Results were determined through patient questionnaires, standardized Canfield photography and blinded physician assessors. Participants were followed for six months. Results: Eighteen females were enrolled and completed the study. The average pain rating was significantly less when LGP-HA + L was administered as reported by participants and blinded investigators. Average rating of bruising and redness were less with LGP-HA + L, but not significant. After six months, 100 percent of participants and 100 percent of the primary and secondary blinded investigators reported no difference in clinical outcome or longevity between the different treatments. There was no difference in adverse events. Conclusion: This is the first trial to report a six-month follow-up in a split-face study comparing LGP-HA + L to LGP-HA alone. All participant and investigator reports found symmetry of the NLFs at six months, thus demonstrating that the addition of lidocaine to LGP-HA does not affect longevity. Administration of LGP-HA + L is associated with less patient discomfort than administration of LGP-HA alone.

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A Randomized, Double-blinded, Placebo-controlled, Multicenter, Efficacy and Safety Study of 3.75% Imiquimod Cream Following Cryosurgery for the Treatment of Actinic Keratoses

Joseph L. Jorizzo MD, Orit Markowitz MD, Mark G. Lebwohl MD, Marc Bourcier MD, James Kulp BS, Tze-Chiang Meng MD, Sharon Levy MD
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Objective: Evaluate cryosurgery followed by 3.75% imiquimod cream to treat actinic keratoses (AK). Methods: Adults with ≥10 AKs on the face underwent cryosurgery of five to 14 lesions. Subjects with ≥5 lesions remaining were randomized to 3.75% imiquimod or placebo cream applied to the entire face daily for two two-week cycles. Efficacy was assessed through week 26. Results: For the cryosurgery/3.75% imiquimod (n=126) and cryosurgery/placebo (n=121) groups, respectively, median total AK reductions were 86.5 and 50 percent, and proportions of subjects with complete clearance were 30.2 and 3.3 percent (P<0.0001, both). Analyzing cryosurgery-treated lesions only, median reductions were 100 and 80 percent (P=0.0008), and subject complete clearance rates were 59.5% and 29.8% (P<0.001), respectively. Only one subject discontinued for a treatment-related adverse event (cryosurgery/3.75% imiquimod group). Limitations: Cryosurgery was performed per usual study center practice and not standardized. Conclusion: A short, cyclical treatment course of field-directed daily 3.75% imiquimod cream following lesion-directed cryosurgery was well tolerated and provided additional therapeutic benefits to cryosurgery alone.

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Onychomycosis Therapy: Past, Present, Future

Aditya K. Gupta MD PhD FAAD FRCP(C), Michael Uro DPM, Elizabeth A. Cooper BESc HBSc
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Methods to treat onychomycosis are varied, using therapies that can be categorized as topical, oral or device-related. Since their development, oral therapies have represented the gold standard for treatment over other methods. However, efficacy with oral therapies remains limited, and safety may be an issue, leaving many patients requiring alternative treatments. With research advances, topical therapies as alternatives for onychomycosis are being investigated with greater interest as new technologies are overcoming previous limitations of topical treatments, such as lack of nail penetration. New device-related topical therapy methods are particularly noteworthy, as they may allow for shorter, more convenient treatments for patients, reducing issues with topical compliance, and, in cases of non-drug light-based therapies, they will avoid potential for drug reactions. Research in these fields is preliminary, and the impact these methods may have on the future of onychomycosis remains to be seen.

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Mechanism of Action and Clinical Benefits of Colloidal Oatmeal for Dermatologic Practice

Rino Cerio MD, Magdalene Dohil MD, Jeanine Downie MD FAAD, Sofia Magina MD, Emmanuel Mahé MD, Alexander J. Stratigos MD
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Colloidal oatmeal has a long history of beneficial use in dermatology. It is a natural product that has an excellent safety record and has demonstrated efficacy for the treatment of atopic dermatitis, psoriasis, drug-induced rash and other conditions. In recent years, in vitro and in vivo studies have begun to elucidate the multiple mechanisms of action of naturally derived colloidal oatmeal. Evidence now describes its molecular mechanisms of anti-inflammatory and antihistaminic activity. The avenanthramides, a recently described component of whole oat grain, are responsible for many of these effects. Studies have demonstrated that avenanthramides can inhibit the activity of nuclear factor κB and the release of proinflammatory cytokines and histamine, well known key mechanisms in the pathophysiology of inflammatory dermatoses. Topical formulations of natural colloidal oatmeal should be considered an important component of therapy for atopic dermatitis and other conditions and may allow for reduced use of corticosteroids and calcineurin inhibitors.

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Clinical Efficacy of a Novel Sonic Infusion System for Periorbital Rhytides

Sona Shah BS and Tina S. Alster MD
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Aging skin is a leading concern of most men and women seeking cosmetic dermatologic consultation. Various in-office procedures as well as topical at-home regimens, are generally prescribed to reduce the signs of aging, but relatively few provide immediate clinical benefit. A novel sonic infusion system that combines sonic micro-massage with an anti-aging serum was studied to determine its immediate effect on a wide range of patients with periocular rhytides. Clinical improvement of periocular rhytides was achieved after a single sonic infusion treatment (30 seconds/eye). Patients with more severe rhytides and those older than 40 years of age showed the best clinical results.

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Review of Actinic Keratosis. Part I: Etiology, Epidemiology and Clinical Presentation

Leonard H. Goldberg MD and Adam J. Mamelak MD
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Clinically, actinic keratoses (solar keratoses) are keratotic lesions that occur on chronically sunlight-exposed skin. Histologically, they are epidermal tumors. Presenting with a spectrum of clinical features, actinic keratoses are believed to be predictors and precursors of invasive squamous cell carcinoma. This, the first of a two-part overview, examines the etiology and epidemiology of actinic keratoses, their clinical and histological features and their role in the development of nonmelanoma skin cancer.

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Hyaluronic Acid Filler and Botulinum Neurotoxin Delivered Simultaneously in the Same Syringe for Effective and Convenient Combination Aesthetic Rejuvenation Therapy

Julie R. Kenner MD PhD
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Facial aesthetics and rejuvenation techniques have been evolving, with the most commonly applied techniques being the use of hyaluronic acid fillers and botulinum neurotoxins. Because of complementary actions, it is common for both products to be used in the same anatomical sites to optimize outcomes, either administered consecutively at one visit or at two separate visits. The author shows for the first time that hyaluronic acid (HA) and botulinum neurotoxin (BNT) can be delivered in combination in the same syringe — at the same time — to rejuvenate the upper face. Not only does concomitant administration result in excellent clinical outcome, without apparently compromising the attributes of either product alone, but this technique enhances the patient experience by allowing the use of small-gauge needles and inherently decreasing, by half or more, the number of needle sticks incurred. Larger studies are underway to study optimal techniques for administering HA and BNT combined in a single syringe.

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Case Reports

Urticarial Hypersensitivity Reaction Caused by Temozolomide

Salma Pothiawala MD MPH, Mei-Yu Hsu MD, F. Clarissa Yang MD, Santosh Kesari MD PhD, Omar A. Ibrahimi MD PhD
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Temozolomide is an oral alkylating agent approved for the treatment of glioblastoma and anaplastic astrocytoma, and is currently under clinical investigation for the treatment of brain metastases from a variety of cancers. Temozolomide is well tolerated, and the reported dermatologic side effects of this medication are limited. Here, the authors report the first case of an urticarial hypersensitivity reaction induced by temozolomide. As this drug will likely be increasingly utilized in the near future, it is important to be aware of its potential to cause adverse cutaneous manifestations.

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Subcutaneous Fat Necrosis/Panniculitis and Polyarthritis Associated With Acinar Cell Carcinoma of the Pancreas: A Rare Presentation of Pancreatitis, Panniculitis and Polyarthritis Syndrome

Jessica Borowicz DO PGY-3, Megan Morrison BS, Daniel Hogan MD, Richard Miller DO FAOC
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An 82-year-old man presented with a two-week history of three painful, inflamed nodules on his lower extremities with symmetric arthritis of multiple joints. He was under the care of hospice for end-stage acinar cell carcinoma of the pancreas. His serum amylase and lipase levels were markedly elevated. An incisional biopsy revealed lobular inflammation of subcutaneous fat, focal fat necrosis with saponification/ghost cells and scattered foreign-body type giant cells consistent with pancreatic fat necrosis/pancreatic panniculitis. This is hypothesized to be initiated by autodigestion of subcutaneous fat secondary to systemic spillage of excess digestive pancreatic enzymes. Enzymes such as amylase, lipase and trypsin are increased in the bloodstream and can affect remote tissues, such as the subcutaneous fat and articular surfaces of joints. This report, along with the patient’s clinical findings, was consistent with PPP syndrome: pancreatic disease, polyarthritis and panniculitis. Although the pancreatic disease of PPP syndrome usually includes pancreatitis, this case represents a report of polyarthritis and panniculitis occurring in the presence of pancreatic carcinoma.

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Palliative Treatment of Paraneoplastic Acanthosis Nigricans With Oral Florid Papillomatosis With Retinoids

Sara L. Swineford MD and Carol R. Drucker MD
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Malignant acanthosis nigricans (MAN) with oral florid papillomatosis is a rare paraneoplastic condition affecting the skin and mucocutaneous tissues associated with an underlying malignancy. It is characterized by proliferation of keratinocytes resulting in papillomatous change and hyperpigmentation of the skin and multiple confluent warty or verrucous lesions of the oral mucous membranes. The oral involvement can interfere with the patient’s ability to eat and drink. There is no specific therapy for this complication. Treatment of the underlying malignancy can lead to improvement of symptoms, but the degree of improvement varies. Here, the authors present a case of MAN with oral florid papillomatosis associated with gastric adenocarcinoma that was treated with oral retinoids resulting in significant clinical improvement of the hyperkeratosis and hyperpigmentation as well as improved patient functionality.

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Departments

Clinical Trial Review

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Clinical Trial Review is a JDD department designed to provide physicians with information on drugs undergoing clinical testing. It is our goal to inform the reader of the status of select drug trials relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

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Pipeline Previews

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Pipeline Previews brings to you information on the newest drugs and medical products as they become available to the dermatological community. This department may include additional information from the manufacturers, plus reports from physicians who wish to share their clinical experience with these new products. In addition, we will inform our readers about the latest drugs receiving Food and Drug Administration (FDA) approval. We trust you will find this information beneficial to your practice and research.

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Archives Volume 9 | Issue 9

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Original Articles

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