Dhwani Mehta MD,a Rebecca Jacobson MD,a Tonja Godsey,b Brian Adams MD MPH,a and Hugh Gloster Jr. MD a
INTRODUCTION: Mohs micrographic surgery (MMS) is successful and cost effective, but may be time consuming as patients are required to wait for final wound repair until margins are clear. We propose for selected cases the “Mohs and Close technique" (MCT), in which the defect is immediately repaired after tumor resection rather than waiting until margins are clear.
METHODS: MCT was only performed on tumors that had clearly de ned borders, low risk histology, whose resulting defect after exci- sion required either a primary or partial closure, and whose repair wouldn’t change to a different repair option if further stages of exci- sion were necessary. Tumor data was recorded for all cases. Time elapsed from tumor resection to completion of wound closure was recorded with and without performing MCT for comparable wounds.
RESULTS: MCT was performed for 456 of 898 cases. Time required without MCT was significantly longer than with MCT when only one stage was performed (P<0.001). There was no statistical difference (P=0.3358) between the two separate techniques for cases which required 2 or more stages.
CONCLUSION: MCT significantly reduces the time needed for selected Mohs cases that require only one stage of excision and therefore can increase the efficiency of MMS.
J Drugs Dermatol. 2016;15(12):1481-1483.
Lyn C. Guenther MD FRCPC,a Anneke Andriessen PhD,b Charles W. Lynde MD FRCPC,c John W. P.Toole BSc MD FRCPC,d Gary R. Sibbald MD FRCPC MACP FAAD M.Ed DSc (Hons),e James N. Bergman MD FRCPC,f Marc Bourcier MD FRCPC,g and Ian D.R. Landells MD FRCPCh
BACKGROUND: Atopic dermatitis (AD) is a common chronic skin condition, associated with significant patient morbidity. There are a myriad of excellent evidenced based guidelines to guide clinicians by an extensive review of all the available treatments. However, while well written and complete these papers may not always allow easy transition to clinical application.
OBJECTIVE: The purpose of this paper was to develop a practical case-based approach for the treatment and maintenance of AD, enabling translation of guidelines into clinical care.
METHODS: After literature searches, selected AD trials and recent existing guidelines were reviewed. Using a nominal group process for consensus, an expert panel of Canadian dermatologists determined the case features and corresponding treatments.
RESULTS: A patient focused clinical pathway with 7 cases was developed. For each case scenario, treatment for mild, moderate, and severe disease was recommended.
CONCLUSION: A practical case-based clinical pathway was developed for easy clinical application and optimal patient care.
J Drugs Dermatol. 2016;15(12):1485-1494.
Lawrence F. Eichenfield MD,a Linda Stein Gold MD,b Walter K. Nahm MD PhD,c Fran E. Cook-Bolden MD,d and David M. Pariser MDe
OBJECTIVE: This randomized, double-blind, placebo-controlled, Phase 2 study compared efficacy, tolerability, and safety of SB204 once or twice daily to vehicle in the treatment of acne vulgaris.
METHODS: Eligible subjects were to be between 12 and 40 years old, have facial acne vulgaris with 25 to 70 non-inflammatory lesions, 20 to 40 inflammatory lesions, no more than 2 nodules, and a baseline Investigator’s Global Assessment (IGA) score of moderate or severe. The co-primary efficacy endpoints were the absolute change in inflammatory and non-inflammatory lesion counts and IGA success rate (baseline to week 12). Safety assessments included reported adverse events (AEs), physical examinations, and laboratory testing. Tolerability was evaluated by the investigators based on the occurrence and severity of erythema, scaling, dryness, pruritus, and burning/stinging.
RESULTS: A total of 213 subjects were randomized: 27 subjects to vehicle once daily; 29 subjects to vehicle twice daily; 53 subjects to SB204 2% twice daily; 52 subjects to SB204 4% once daily; and 52 subjects to SB204 4% twice daily. When compared to vehicle, treatment with all 3 SB204 regimens significantly reduced the absolute inflammatory lesion count and SB204 4% once daily reduced the absolute non-inflammatory lesion count. Treatment with SB204 4% once daily demonstrated a significant reduction in percent inflammatory lesions by week 4. There were no significant differences in the IGA success rates between groups at the end of treatment. All treatment regimens of SB204 were found to be safe and well tolerated.
CONCLUSIONS: When compared to vehicle, SB204 2% and SB204 4% significantly decreased the absolute inflammatory lesion count and SB204 4% once daily also significantly decreased the absolute non-inflammatory lesion count in subjects with acne vulgaris treated for 12 weeks. Treatment with SB204 2% and 4% was found to be safe and well tolerated.
J Drugs Dermatol. 2016;15(12):1496-1502.
Erika C. von Grote PhD, Kiruthi Palaniswamy PharmD, and Matthew H. Meckfessel PhD
Occupational irritant contact dermatitis (ICD) affecting the hands is a common and difficult-to-manage condition. Occupations that necessitate contact with harsh chemicals, use of alcohol-based disinfectants, and frequent hand washing elevate the risk of ICD. Management strategies that do not adequately prevent accumulated damage and repair skin, can develop into chronic dermatoses which negatively impact work productivity and quality of life. A 2-step skin-care regimen (Excipial Daily Protection Hand Cream (EP) and Excipial Rapid Repair Hand Cream (ER), Galderma Laboratories, L.P.) has been developed as a daily-use management strategy to protect and repair vulnerable hands. The protective barrier cream is formulated with aluminum chlorohydrate and designed for pre-exposure application to enhance the skin’s natural protective barrier and minimize excessive moisture while wearing protective gloves. The repair cream, a lipid-rich formulation, is intended for post-exposure application to rehydrate and facilitate the skin’s natural healing process. The results of 3 clinical studies highlighted in this review demonstrate how the use of a 2-step skin-care regimen offers a greater protective effect against ICD than the use of barrier cream alone, and also how the formulation of the barrier cream used in these studies helps minimize the occlusion effect caused by gloves and does not interfere with the antibacterial efficacy of an alcohol-based hand sanitizer. This 2-step skin-care regimen is effectively designed to manage and minimize the risk of ICD development in a variety of patients and provides clinicians an additional tool for helping patients manage ICD.
J Drugs Dermatol. 2016;15(12):1504-1510.
Hema Sundaram MD,a Ana Du BS,b Margarita Yatskayer MS,b Stephen Lynch PhD,b Yevgeniy Krol,c and Christian Oresajo PhDb
BACKGROUND: Topical products with epidermal lipids in a ceramide-dominant ratio were originally developed to address atopic dermatitis. They have been used by extension to address the barrier deficits of aging skin, and after laser resurfacing and other barrier-disrupting procedures. The purpose of this study was to evaluate efficacy, tolerability, and safety of a novel formulation containing high levels of physiological barrier lipids, in a unique cholesterol-dominant ratio hypothesized to directly address the specific epidermal lipid imbalances of aging skin.
METHODS: An 8-week, single-center study was conducted on females aged 55 to 75 with mild to moderate fine lines and wrinkles, and other stigmata of facial photodamage. Evaluations were performed at baseline, immediately after rst use of the cholesterol-dominant test formulation, and at weeks 4 and 8. Efficacy evaluations comprised blinded expert grading of 9 skin attributes, bioinstrumental measurements of trans-epidermal water loss (TEWL) and stratum corneum hydration, standardized digital imaging, and self-assessment questionnaires. Tolerability was scored objectively and subjectively, and by grading of skin dryness. Adhesive tape extracts were analyzed biochemically for epidermal lipids, and by double-staining to detect mature vs. immature corneocytes. In a separate study, the effects of pre- or post-treatment with the test formulation on barrier recovery following traumatic tape stripping of forearm skin were assessed via measurements of TEWL and stratum corneum hydration.
RESULTS: Statistically significant improvements occurred in all facial skin attributes (weeks 4 and 8), TEWL (week 8), and stratum cor- neum hydration (weeks 4 and 8). There were significant increases in total ceramides and cholesterol, including ceramide isoforms not present in the test formulation itself; and a statistically significant increase in the ratio of mature to immature corneocytes at week 8. Forearm skin treated with the test formulation after traumatic tape stripping recovered barrier function significantly faster than untreated skin. Pre-treatment for 1 week prior to traumatic tape stripping had a significant protective effect. Tolerability and safety of the test formulation were excellent.
CONCLUSIONS: This cholesterol-dominant lipid formulation offers a new paradigm of primary skin barrier repair specifically targeted to- ward aging skin. Correction of age-related epidermal lipid deficits directly addresses the underlying cause and the profound sequelae of barrier dysfunction in aging skin. This may also be of utility to optimize skin tolerance, response and recovery from aesthetic procedures and other topical treatments, and for dermatoses associated with barrier dysfunction, such as rosacea. The formulation achieved sustained improvements in barrier function throughout the course of the 8-week study, had a protective effect when applied prior to barrier insult, and mediated more rapid recovery when applied after barrier insult. Significant increases in total epidermal ceramides, cholesterol and triglycerides, and in mature versus immature corneocytes, indicated both structural and functional normalization of the skin barrier, and possibly a broader-based stimulation of ceramide synthesis. The formulation had excellent tolerability and safety profiles, even in subjects with sensitive skin.
J Drugs Dermatol. 2016;15(12):1513-1523.
This paper aims to review articles related to facial fillers in the periorbital area, forehead, and temple. Anatomy, anatomical changes with aging, techniques of rejuvenation and facial harmonization with fillers are reviewed. Topics for complication prevention and management including knowledge of danger zones, timing of hyaluronidase injections, aspiration, definition a small aliquot, and thoughts about particle size are discussed.
J Drugs Dermatol. 2016;15(12):1524-1531.
BACKGROUND: The desire for and use of nonsurgical injectable esthetic facial treatments is on a rise in Asia. Recent advances, including more versatile facial fillers, refined injection techniques, and adoption of a global facial approach, have in turn contributed to improved patient outcomes and increased patient satisfaction. The sought after nonsurgical treatments include the use of botulinum toxin, con- touring of the face with soft tissue fillers, and thinning of the face with injection lipolysis.
AIM:To achieve a leaner, oval face shape with smooth contours.
METHODS: A combination technique was applied, whereby narrowing of face was achieved with use of botulinum toxin, contouring with soft tissue llers, and thinning the face with injection lipolysis. Treatments were applied on 15 women aged between 25 and 40 years and observed with follow up for 12 weeks. Hyaluronic acid (HA)-based dermal fillers (Perlane, Voluma, and Juvederm), botulinum toxin type A (Botox), and a lipolytic solution of phosphatidylcholine with deoxycholate (Dermastabilion, Aesthetic Dermal, Spain) were used to achieve a natural look in these patients with a fuller appearance of the face. The procedure was performed to reduce the facial width using botulinum toxin type A and the reduction of submental and cheek fat by injecting lipolysis injection.
RESULTS: All the women (n = 15) had edema for up to 2 weeks after undergoing lipolysis; however, two patients had edema for 3 weeks. After injecting the patient with botulinum toxin type A, no adverse event was observed; however, after using HA-based filler, one patient was observed to have bruising on the chin.
CONCLUSION: Use of HA-based fillers, neuromodulators (botulinum toxin), and injectable lipolytics are well-tolerated and are effective nonsurgical modalities to achieve facial recontouring for slimming of the face.
J Drugs Dermatol. 2016;15(12):1536-1542.
John H. Joseph MD,a Laura L. Eaton RN BSN,b James Robinson MS,c Allison Pontius MD,d and Edwin F.Williams III MDd
OBJECTIVE: To evaluate the duration of effect of a single dose of 120 units of abobotulinumtoxinA for the treatment of moderate to severe glabellar lines.
DESIGN: Investigator-initiated, prospective, multi-center, open-label study.
Material and Methods: This open-label trial of thirty subjects with moderate to severe glabellar lines at maximum frown was per- formed at 2 private plastic surgery clinics. 120 units of abobotulinumtoxinA was injected in 5 equal aliquots (24 units each) into each of 5 injection sites in the glabellar complex. Investigator and subject assessments of wrinkle severity at maximum frown and repose using 4-point scales and adverse events were conducted. Follow-up was monthly for up to 11 months.
RESULTS: The median duration of response for all subjects, as assessed by the investigator, was 150 days (95% CI: 120, 180). The median duration of response was 165 days (95% CI: 90, 180) for subjects with Grade 2 (Moderate) wrinkles at baseline and 75 days (95% CI: 30, 120) for subjects with Grade 3 (Severe) wrinkles at baseline. Overall, 76.7% of subjects had a duration of ≥ 120 days. At the end of study (day 300) 9/16 (53%) of subjects who were Grade 3 at baseline still rated themselves as not returning to Grade 3, demonstrating ongoing improvement. Adverse events were mild and transient. There were no events of lid or brow ptosis.
CONCLUSIONS: The 120 units of abobotulinumtoxinA were significantly effective in reducing glabellar lines in subjects with Grade 2 (Moderate) wrinkles at baseline for a longer duration than the reported 85 days in the FDA Phase III randomized, placebo-controlled clinical studies using a standard 50 unit dose. Subject satisfaction was high. There was no increase in the incidence of adverse events with this higher dose.
J Drugs Dermatol. 2016;15(12):1544-1549.
Shino Bay Aguilera DO FAAD,a Sean Branch DO FAAD,b and Luis Soro DO FAADa
The authors present a reproducible and effective technique utilizing poly-L-lactic acid for panfacial revolumization. The variable dilution ratios, reconstitution times, injection techniques and rates of nodule formation with poly-L-lactic acid can be intimidating to even experienced injectors. While there is no single cookie-cutter approach to facial volumization, this 6-step “Precise Sculpt” technique can be used as a template to reliably achieve optimal results while minimizing the risk of adverse events.
J Drugs Dermatol. 2016;15(12):1550-1556.
Nicole Hayre MD,a Melanie Palm MD,b and Peter Jenkin MDc
OBJECTIVE: The aim of this study was to compare clinical outcomes of a noninvasive selective radiofrequency (RF) eld device (BTL Vanquish METM, BTL Industries Inc., Boston MA) with its predecessor (VanquishTM, BTL Industries Inc., Boston MA). The BTL Vanquish METM system has been thoroughly redesigned for more efficient, predictable and homogenous energy delivery to the targeted tissue.
MATERIALS AND METHODS: In this multi-center study, 36 subjects with BMIs under 30 were randomly assigned to be treated in Group A (BTL Vanquish METM) or Group B (VanquishTM) in order to obtain a side by side comparison of the devices’ ef cacies. Each subject re- ceived 4 weekly 45-minute treatments with the device determined by their group assignments. Measurements of subject’s abdominal fat were taken prior to the first treatment and again four weeks after finishing the final treatment.
RESULTS: The primary outcome was abdominal fat thickness reduction as measured by ultrasound one month following each subject’s final treatment. Thirty four subjects completed the study. Two patients did not complete their treatments due to the reasons unrelated to the study (one from each group). Subjects in Group A treated with BTL Vanquish METM had an abdominal fat thickness reduction of 4.17 mm, or 29.46%, while subjects in Group B treated with VanquishTM had an abdominal fat thickness reduction of only 2.72 mm, or 15.21%. The 4 weekly treatments with BTL Vanquish METM in Group A produced a 53% higher reduction (4.17 mm vs 2.72 mm) of abdominal fat layer thickness than those in Group B. The standard deviation of ultrasound measurements in Groups A and B were 1.42mm and 2.21mm, respectively.
Assuming a homogenous response across the entire treatment area, the volume of fat reduced was calculated by multiplying the average measured reduction in fat layer by the surface area of the treatment applicator (2100 cm2; 325.5 square inches). It was calculated that Group A patients lost an average of 0.876 liter (0.23 liquid gallon) of fat, while Group B patients lost 0.571 liter (0.15 liquid gallon) of fat.
DISCUSSIONS AND CONCLUSIONS: The mean difference between the tested groups was statistically significant proving better outcomes in the Vanquish METM than its predecessor. Furthermore, the reduction in standard deviation of fat reduction measurements in Group A vs Group B is evidence that the Vanquish METM provides more consistent performance.
J Drugs Dermatol. 2016;15(12):1557-1561.
Elizabeth T. Makino BS CCRA MBA,a Kuniko Kadoya PhD,a Monya L. Sigler PhD,b Peter D. Hino MD FAAD,b and Rahul C. Mehta PhDa
BACKGROUND: Pigmentary changes in people of different ethnic origins are controlled by slight variations in key biological pathways leading to different outcomes from the same treatment. It is important to develop and test products for desired outcomes in varying ethnic populations.
OBJECTIVES: To develop a comprehensive product (LYT2) that affects all major biological pathways controlling pigmentation and test for clinical efficacy and safety in different ethnic populations.
METHODS: A thorough analysis of biological pathways was used to identify ingredient combinations for LYT2 that provided optimal melanin reduction in a 3-D skin model. Expression of four key genes for melanogenesis, TYR, TYRP-1, DCT, and MITF was analyzed by qPCR. Clinical study was conducted to compare the efficacy and tolerability of LYT2 against 4% hydroquinone (HQ).
RESULTS: Average melanin suppression by LYT2 in 7 independent experiments was 45%. All four key genes show significant down- regulation of expression. LYT2 provided statistically significant reductions in mean overall hyperpigmentation grades as early as week 2 compared to baseline, with continued significant improvements through week 12 in all ethnic groups tested.
CONCLUSION: We have successfully combined management of 6 categories of pathways related to melanogenesis: melanocyte activation, melanosome development, melanin production, melanin distribution, keratinocyte turnover, and barrier function to create a comprehensive HQ-free product. The outcome clearly shows greater pigmentation control with LYT2 compared to other HQ-free products in skin tissue models and earlier control in clinical studies compared to 4% HQ. Clinical study shows pigmentation control benefits of LYT2 in people of Caucasian, Hispanic, and African ethnic origins.
J Drugs Dermatol. 2016;15(12):1562-1570.
Joel Schlessinger MD,a Subhash Saxena PhD,b and Stuart Mohrb
INTRODUCTION: Hyperpigmentation is a primary concern for many cosmetic patients because of its high rate of occurrence and significant impact on perceived age. While 4% hydroquinone has been the gold-standard of treatment, there is a growing interest in non-hydroquinone solutions, however, many of these newer solutions fail to deliver equivalent improvement.
METHODS: This double-blind, randomized, split-face study compares the effects of a new OTC non-hydroquinone lightening product (JM) to an available 4% hydroquinone lightening solution (OB) on the appearance of hyperpigmentation, texture, and ne lines and wrinkles. Comparisons were determined by both physician assessment and subject self-assessment at baseline, 4, 8, and 12 weeks.
RESULTS: Physician assessment showed statistically equivalent improvement on both sides of the face with the JM side showing equivalent or superior average improvement in all assessed categories. Subject self-assessment showed a significant preference for the JM product over the 4% hydroquinone and a substantially higher perception of overall improvement over 4% hydroquinone (P=0.058).
DISCUSSION: Physician assessment showed equal or superior average improvement in all measured categories with no statistically significant difference between the two sides. Subject self-assessment, however, showed a significant and growing preference toward the investigated JM product over the course of the study. Overall, the results of this study show the JM product to be equivalent if not superior to 4% hydroquinone for results and patient satisfaction.
J Drugs Dermatol. 2016;15(12):1571-1577.