The 200-Year Timeline on Botulinum Toxin: From Biologic Poison to Wonder Drug.

The history of botulinum toxin dates back to the late 1700s, when food preparation, storage, and later canning practices led to outbreaks of botulism across Europe and the United States. It is from these initial incidents that the remarkable discovery of botulinum toxin was eventually made, sparking over 200 years of further scientific inquiry and medical innovation. To date, 6 botulinum toxin products have been commercialized in North America with numerous indications across the specialties of ophthalmology, neurology, urology, dermatology, plastic surgery, and otolaryngology. This article traces the key moments and important players in the remarkable journey of this biologic poison and wonder drug. J Drugs Dermatol. 2024;23(1) doi:10.36849/JDD.7288.

Identifying critical quality metrics in Mohs Surgery: A national expert consensus process.

BACKGROUND: Amid a movement toward value-based healthcare, increasing emphasis has been placed on outcomes and cost of medical services. To define and demonstrate the quality of services provided by Mohs surgeons, it is important to identify and understand the key aspects of Mohs micrographic surgery (MMS) that contribute to excellence in patient care. OBJECTIVE: The purpose of this study is to develop and identify a comprehensive list of metrics in an initial effort to define excellence in MMS. METHODS: Mohs surgeons participated in a modified Delphi process to reach a consensus on a list of metrics. Patients were administered surveys to gather patient perspectives. RESULTS: Twenty-four of the original 66 metrics met final inclusion criteria. Broad support for the initiative was obtained through physician feedback. LIMITATIONS: Limitations of this study include attrition bias across survey rounds and participation at the consensus meeting. Furthermore, the list of metrics is based on expert consensus instead of quality evidence-based outcomes. CONCLUSION: With the goal of identifying metrics that demonstrate excellence in performance of MMS, this initial effort has shown that Mohs surgeons and patients have unique perspectives and can be engaged in a data-driven approach to help define excellence in the field of MMS.

A Single-Center, Observational Experience With a Bovine Collagen Wound Dressing for Distal Lower Extremity Surgical Defects.

BACKGROUND: Biologic dressings help treat many dermatologic conditions. Their use in dermatologic surgery continues to expand as new dressings are developed. OBJECTIVE: To discuss the authors' experience with a bovine-derived collagen wound dressing in surgical defects on the distal lower extremity. METHODS AND MATERIALS: Over a 9-month period, 24 surgical defects in 20 patients were treated with a bovine-derived collagen wound dressing. All surgical defects were located below the knee. The average defect was 6.9 cm2 (range 1.0-18.0 cm2). The mean duration until healing completion was 117.3 days (range 63-183). RESULTS: The treated surgical defects demonstrated shortened healing time, improved cosmetic outcome, decreased wound drainage, and decreased pain compared with that traditionally seen in second intention healing. Bovine-derived collagen wound dressings should be considered to facilitate the healing of surgical defects on the distal lower extremity that would otherwise be left to heal by the second intention. J Drugs Dermatol. 2023;22(12):1149-1152. doi:10.36849/JDD.5404.

Timeline: The Evolution of Fellowship Training in Micrographic Surgery and Dermatologic Oncology.

The Accreditation Council for Graduate Medical Education (ACGME) granted accreditation to the first 5 Procedural Dermatology Fellowship Training Programs in 2004. The name of the training program was changed from Procedural Dermatology to Micrographic Surgery and Dermatologic Oncology by the ACGME/Residency Review Committee for Dermatology in 2014. The American Board of Dermatology/American Board of Medical Specialties conducted the first certification examination in Micrographic Dermatology Surgery in October 2021. This article chronicles the history and development of the subspecialty. J Drugs Dermatol. 2022;21(8):861-863.: doi:10.36849/JDD.6933.

2020 IDEOM Annual Meeting: Actinic Keratosis Stakeholders Survey Identifies Gaps in Research and Care.

This is a report of the survey results from the International Dermatology Outcome Measures (IDEOM) actinic keratosis (AK) workgroup. The purpose of the survey was to compile a list of gaps within AK care and management that require refinement. The results were discussed at the IDEOM annual meeting held virtually on October 23–24, 2020. This built a framework with which the AK workgroup, which consisted of physicians, patients, and pharmaceutical scientists, discussed at length in their breakout session at the meeting. The electronic survey was distributed to patients, pharmaceutical scientists, and leading physician experts in the field via email on September 22, 2020, with a deadline of October 2, 2020. The survey consisted of three open-ended prompts concerning key gaps and/or unmet needs in (1) the care of AKs, (2) outcome measurement of AKs in clinical trials and, (3) the measurement of AKs in clinical practice. The results were qualitative, with a response rate of 47%. Responses included reform of outcome measures for clinical trials, a methodology for evaluating the efficacy of preventative measures, and a comparison of treatments to establish a treatment protocol, among other efforts. This paper will also provide a brief overview of the current state of the AK outcome measures, emphasizing the heterogeneity of the measures and detailing the AK workgroup's future efforts to create a reliable and applicable core outcome measure set. J Drugs Dermatol. 2022;21(2):128-134. doi:10.36849/JDD.6360.

Comparison of Modern Super Wide Field Microscopy Systems in Mohs Surgery.

Microscopic interpretation of frozen tissue sections is fundamental to Mohs micrographic surgery. Mohs surgeons spend a significant portion of their day at the microscope. Eye strain and fatigue, in addition to musculoskeletal strain, may increase the risk of interpretation errors as well as musculoskeletal injury.3,4,5,7 Advances in microscope systems have allowed for more efficient and reliable reading of slides as well as decreased physical strain. In particular, the advent of super wide field (SWF) microscopy, which includes lower power objective lenses as well as wider eyepieces, allows for a much larger area to be viewed, decreasing eye strain.2,5 Also, more ergonomically designed systems help to decrease musculoskeletal fatigue and injury.7 In an update to an article from Goldsberry et al, that compared older SWF microscope systems,1 we review three newer systems for comparison: Leica DM2500, Nikon Ci-L, and Olympus Bx53 (Figure 1.) Each system reviewed demonstrates ergonomic design and super wide fields of view, allowing for efficient interpretation of tissue and decreased eye strain and musculoskeletal strain compared to older systems. The Nikon Ci-L had the largest possible VFA at 490.87 mm2, 40% more area than the Olympus and 56% more area than the Leica. J Drugs Dermatol. 2021;20(10):1093-1095, doi:10.36849/JDD.6083.

A Review of Hedgehog Inhibitors Sonidegib and Vismodegib for Treatment of Advanced Basal Cell Carcinoma.

Basal cell carcinoma (BCC) is the most common malignancy in fair-skinned populations. Most cases are successfully treated with surgery, but in advanced BCC—including locally advanced BCC and metastatic BCC—surgery is likely to result in substantial morbidity or unlikely to be effective. In those patients, the systemic Hedgehog inhibitors (HHIs) sonidegib and vismodegib are the only approved pharmacologic treatment option. Although a number of clinical studies highlight the similarities and differences between the two HHIs, no head-to-head clinical comparison is available. Results from the pivotal BOLT and ERIVANCE clinical studies for sonidegib and vismodegib, respectively, demonstrate similar efficacy measured by objective response rate, complete response rate, and histologic tumor subtype. Safety results for both studies are comparable with similar common adverse events reported for muscle spasms, alopecia, and dysgeusia. A notable difference between sonidegib and vismodegib is their respective pharmacokinetic profiles with sonidegib reaching peak concentration in plasma within 2–4 hours of dosing and steady state in plasma achieved by week 17 of treatment, while vismodegib reaches peak plasma concentration approximately 2 days after a single dose and steady state within 21 days of repeated dosing. This review compares efficacy, safety, and pharmacokinetics of sonidegib and vismodegib based on published literature to date. J Drugs Dermatol. 2021;20(2):156-165. doi:10.36849/JDD.5657 THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Efficacy and safety of ingenol disoxate gel in field treatment of actinic keratosis on full face, scalp or large area (250 cm2) on the chest: results of four phase 3 randomized controlled trials.

INTRODUCTION: Actinic keratosis (AK) is a skin condition arising from chronic exposure to ultraviolet light and may lead to the development of malignancies. This trial aimed to evaluate efficacy and safety of ingenol disoxate gel (IngDsx, 0.018% for face/chest [FC]; 0.037% for scalp [S]), versus vehicle. METHODS: Four identical phase 3 trials in patients with AK on the full face/up to 250cm2 of chest or full balding scalp, with an initial 8-week period and 12-month follow-up, were conducted. FC and S trials were pooled for analysis. The primary endpoint was complete clearance at Week 8. RESULTS: Across trials, 616 patients were randomized to FC and 626 to S, with 410 and 420 assigned to receive IngDsx, respectively. In the FC and S trials, 25.9% and 24.5% of patients in the IngDsx group, respectively, achieved the primary endpoint. IngDsx was relatively well tolerated. During extended follow-up, there were more identified non-melanoma skin malignancies in the IngDsx group than vehicle group; HR: 2.38 (95% CI: 1.28, 4.41). CONCLUSION: Treatment with IngDsx was superior to vehicle on all clinical endpoints, patient-reported and cosmetic outcomes. During the 12-month follow-up, slightly increased skin malignancies in the treatment area were identified, potentially due to unintentional detection bias.

Universal Protocol in Mohs Micrographic Surgery: Incorporating a "Time Out" Procedure in Histopathologic Interpretation

In 1999, the Institute of Medicine's (IOM) first report, "To Err Is Human", brought forth the issue of medical error in patient care.1 In this publication, the IOM recognized that mistakes or failures to prevent mistakes were mostly caused by flawed systems, processes, and conditions. It outlined a four-tiered approach to improve safety including: 1) development of leadership, research, tools, and protocols to enhance the knowledge base on safety, 2) a nationwide public mandatory reporting system and encouraging voluntary participation to identify and learn from errors, 3) oversight organizations, professional groups, health care purchasers to raise performance standards and expectations, and 4) implementation of safety systems in the healthcare organization to ensure delivery of safe practice. This was the first roadmap towards a safer health system.

Prevention of Progression of Lipedema With Liposuction Using Tumescent Local Anesthesia: Results of an International Consensus Conference.

BACKGROUND: Lipedema is a chronic, progressive disorder of subcutaneous adipose tissue that usually affects the lower extremities of women. Also known as "two-body syndrome," the fat accumulations in lipedema are unsightly and painful. The disorder is well-known in Europe but is largely unrecognized and underdiagnosed in the United States. OBJECTIVE: To hold the First International Consensus Conference on Lipedema with the purpose of reviewing current European guidelines and the literature regarding the long-term benefits that have been reported to occur after lymph-sparing liposuction for lipedema using tumescent local anesthesia. METHODS: International experts on liposuction for lipedema were convened as part of the First International Congress on Lipedema in Vienna, Austria, June 9 to 10, 2017. RESULTS: Multiple studies from Germany have reported long-term benefits for as long as 8 years after liposuction for lipedema using tumescent local anesthesia. CONCLUSION: Lymph-sparing liposuction using tumescent local anesthesia is currently the only effective treatment for lipedema.

Efficacy and safety of ingenol mebutate gel in field treatment of actinic keratosis on full face, balding scalp, or approximately 250 cm2 on the chest: A phase 3 randomized controlled trial.

BACKGROUND: Ingenol mebutate (IngMeb) 0.015% or 0.05% is approved for actinic keratosis (AK) areas of 25 cm2 or less; some patients require treatment of larger fields. OBJECTIVE: To determine efficacy and safety of IngMeb 0.027% in areas of AK of up to 250 cm2 during an 8-week initial assessment period and extended 12-month follow-up. METHODS: This phase 3, randomized, double-blind, vehicle-controlled trial (NCT02361216) enrolled adult patients with 5 to 20 AK lesions on the face/scalp (25-250 cm2) or chest (approximately 250 cm2). Patients received once-daily IngMeb or vehicle for 3 consecutive days on the full face, full balding scalp, or approximately 250 cm2 on the chest. The primary endpoint was complete AK clearance (AKCLEAR 100; week 8). Additional endpoints included partial AK clearance (AKCLEAR 75), recurrence, patient satisfaction, cosmetic outcome, and safety. RESULTS: IngMeb was superior to vehicle for complete AK clearance (21.4% vs 3.4%, P < .001) and AK clearance of 75% or greater (59.4% vs 8.9%, P < .001) at week 8. Probability of sustained clearance during the 12-month follow-up was 22.9% for patients treated with IngMeb. Increased treatment satisfaction and cosmetic outcomes were observed with IngMeb versus vehicle. No unexpected safety signals were identified. LIMITATIONS: Localized skin responses hindered maintenance of double-blinding. CONCLUSIONS: IngMeb 0.027% was superior to vehicle for treatment of AK areas of up to 250 cm2. The safety profile of IngMeb was as expected.

An expert panel consensus on opioid-prescribing guidelines for dermatologic procedures.

BACKGROUND: Opioid overprescribing is a major contributor to the opioid crisis. The lack of procedure-specific guidelines contributes to the vast differences in prescribing practices. OBJECTIVE: To create opioid-prescribing consensus guidelines for common dermatologic procedures. METHODS: We used a 4-step modified Delphi method to conduct a systematic discussion among a panel of dermatologists in the fields of general dermatology, dermatologic surgery, and cosmetics/phlebology to develop opioid prescribing guidelines for some of the most common dermatologic procedural scenarios. Guidelines were developed for opioid-naive patients undergoing routine procedures. Opioid tablets were defined as oxycodone 5-mg oral equivalents. RESULTS: Postoperative pain after most uncomplicated procedures (76%) can be adequately managed with acetaminophen and/or ibuprofen. Group consensus identified no specific dermatologic scenario that routinely requires more than 15 oxycodone 5-mg oral equivalents to manage postoperative pain. Group consensus found that 23% of the procedural scenarios routinely require 1 to 10 opioid tablets, and only 1 routinely requires 1 to 15 opioid tablets. LIMITATIONS: These recommendations are based on expert consensus in lieu of quality evidence-based outcomes research. These recommendations must be individualized to accommodate patients' comorbidities. CONCLUSIONS: Procedure-specific opioid prescribing guidelines may serve as a foundation to produce effective and responsible postoperative pain management strategies after dermatologic interventions.

Treatment of Solitary Keratoacanthoma of the Nose With Intralesional Methotrexate and Review of the Literature

Keratoacathoma (KA) is a unique clinical pathological entity that is difficult to categorize. Differentiating a KA from a squamous cell carcinoma (SCC) is important for treatment implications but is often challenging. We report a patient with a solitary KA of the skin of the right ala successfully treated with intralesional (IL) injections of methotrexate (MTX). We also provide a review of the literature on IL-MTX as a treatment modality for KA. J Drugs Dermatol. 2019;18(7):693-696.

Histopathology of Basal Cell Carcinoma After Treatment With Vismogedib

Background: Vismodegib used in the treatment of metastatic basal cell carcinoma (BCC) or locally advanced, recurrent BCC not amenable to surgery or radiation leads to various clinical changes. Objective: Aim was to elucidate the histopathology that corresponds to tumor involution observed with vismodegib therapy. Methods: Retrospective case series of patients treated with vismodegib between May 2012 and April 2017 with intra- or post-treatment biopsy. Results: 42 biopsy specimens and 4 Mohs frozen sections were analyzed. Necrosis, fibrosis, and increased plasma cells were common features. Limitations: Single center study. Conclusion: The histologic findings of BCCs treated with vismodegib correlate with clinical response. J Drugs Dermatol. 2019;18(2):136-138.

Is It Time to Rethink What Thickness Really Means as a Prognostic Indicator in Melanoma? Ten Questions We Should Be Asking Ourselves

Tumor thickness has been a key tool for prognosis of melanoma. However, with the advent of gene expression profile (GEP) assays for melanoma and the discovery of multiple melanoma subtypes, it is time to reassess how we view tumor thickness as a prognostic indicator.Herein we present ten questions for consideration by the shrewd practitioner when considering prognostic factors of melanoma. J Drugs Dermatol. 2019;18(2):148-151.

Safety Studies in the Field of Liposuction: A Systematic Review.

BACKGROUND: There is an increasing demand for safety standards for cosmetic treatments. With regard to liposuction, interdisciplinary consensus is lacking, especially regarding treatment setting and physician specialty. OBJECTIVE: A solid, independent interpretation of scientific data on safety requires a systematic approach, which is the aim of this study. METHODS: A systematic literature search was conducted for safety studies about liposuction through April 2017. Fatalities and/or reported serious adverse events served as outcome measures for safety. RESULTS: Twenty-four studies were included. Factors that contributed to increased serious complication and mortality risk were: use of the (super)wet technique; use of systemic anesthetics, especially general anesthesia and intravenous sedation; execution by a plastic surgeon; execution in an operating room; and combination with other procedures. CONCLUSION: Liposuction using tumescent local anesthesia has been shown to be the safest method of fat removal, especially if no or only minimal systemic anesthesia is used. Performance of this technique in an office-based setting has been proven to be safe beyond doubt. When systemic anesthesia is used, an outpatient or ambulatory surgery facility seems also safe. Regardless of the physician specialty, knowledge and training on the execution of the tumescent procedure are vital to ensure optimal safety.