Rachel E. Epstein DO and James Spencer MD MS
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
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.
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.
Stephen E. Mercer MD PhD, Rebecca Kleinerman MD,Gary Goldenberg MD, Patrick O. Emanuel MD
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.
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.
Andy Pickett PhD and Karen Perrow PhD
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.
Ghada A. BinSaif MD, Abdullah Al Samary MD, Saad Al Mohizea MD
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.
Mary P. Lupo MD FAAD, Glenda Swetman MD, William Waller MD
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
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
Joseph L. Jorizzo MD, Orit Markowitz MD, Mark G. Lebwohl MD, Marc Bourcier MD, James Kulp BS, Tze-Chiang Meng MD, Sharon Levy MD
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.
Aditya K. Gupta MD PhD FAAD FRCP(C), Michael Uro DPM, Elizabeth A. Cooper BESc HBSc
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.
Rino Cerio MD, Magdalene Dohil MD, Jeanine Downie MD FAAD, Sofia Magina MD, Emmanuel Mahé MD, Alexander J. Stratigos MD
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.
Sona Shah BS and Tina S. Alster MD
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
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
Leonard H. Goldberg MD and Adam J. Mamelak MD
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.
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.
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.
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.