Noncollagen Dermal Fillers: A Summary of the Clinical Trials Used for Their FDA Approval BACKGROUND Many noncollagen dermal fillers (NCDFs) have been approved by the FDA and are currently the second-most performed noninvasive cosmetic procedure. OBJECTIVE To summarize and compare the clinical trials reviewed by the United States FDA in the approval of NCDFs. METHODS The FDA Premarket Approval (PMA) site was queried, and the year of approval, indication, design, primary end points, touch-ups, retreatments, and study duration were extracted and tabulated. RESULTS Twenty-one FDA-approved NCDFs from 2003 to 2018 and 24 Summary of Safety and Effectiveness documents were reviewed. Differences in the trial design and in reporting of data make comparisons difficult. This article provides comparative tables to make interpreting the various trial results more straightforward. Limitations Primary efficacy end points and the way that filler volumes were reported varied by company. This article does not focus on secondary end points or safety data. CONCLUSION A comprehensive and comparative review of clinical trials of NCDFs by the FDA demonstrates that differences in data reporting, especially for touch-ups and retreatments, make filler duration difficult to compare and interpret. Understanding of the trial design will allow the clinician to become more astute and allow for better management of patient expectations in clinical practice. Address correspondence and reprint requests to: Betty Jiang, MD, MHS, Department of Dermatology, Duke University, 40 Duke Medicine Circle, Durham, NC 27710, or e-mail: bettyjiangmd@gmail.com Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.dermatologicsurgery.org). J. Woodward is a consultant for Allergan, Galderma, Metz Aesthetic, and Prollenium and an investigator for Allergan. L. Baumann is an investigator for Allergan, Galderma, Revanesse, Merz, and Suneva. © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. |
A Review of Sclerosing Foam Stability in the Treatment of Varicose Veins BACKGROUND Varicose veins are common clinical entities. Foam sclerotherapy is a minimally invasive and simple procedure; however, the side effects, efficacy, and stability of sclerosing foam are not ideal. OBJECTIVE To summarize the current studies on sclerosing foam stability and promote foam sclerotherapy development. MATERIALS AND METHODS We reviewed the literature before June 2018 and included only representatives studies on sclerosing foam stability. We summarized the foam half-life time (FHT) of polidocanol (POL) under 17 preparation conditions and the FHT of sodium tetradecyl sulfate under 21 preparation conditions. The preparation conditions included various combinations of temperature, liquid–gas ratio, preparation method, etc. RESULTS The FHT of POL varied between 40 and 4,000 seconds under different conditions. The FHT of sodium tetradecyl sulfate varied from 25.7 to 390 seconds. The higher the drug concentration, the lower the temperature required to increase foam stability. The addition of surfactant greatly increased foam stability. For different gas compositions, the FHT sequence was as follows: CO2 < CO2 + O2 < O2 < air. CONCLUSION Foam stability can be improved by changing the preparation conditions; therefore, the role of surfactants and predictive methods for FHT are worth investigating further. Address correspondence and reprint requests to: Wentao Jiang, PhD, Department of Applied Mechanics, Laboratory of Biomechanics, Sichuan University, NanYihuan Road No. 24, WuHou District, Chengdu 610065, China, or e-mail: scubme@aliyun.com Supported by the Key projects of the Ministry of Science and Technology of China (No. 2017YFB0702500), Projects funded by the National Natural Science Foundation Project of China (No. 11772210), Sichuan Province Project for Applied Basic Research (No. 2016JY0182), and Sichuan University experimental technology project (20171064). The authors have indicated no significant interest with commercial supporters. © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. |
Aggressive Digital Papillary Adenocarcinoma Initially Misdiagnosed as Basal Cell Carcinoma No abstract available |
Preparation of the Mohs Debulk Specimen for More Efficient, Accurate Laboratory Processing No abstract available |
Commentary on Influences of Age, Sex, and Body Mass Index on the Depth of the Superficial Fascia of the Arm and Thigh No abstract available |
Commentary on Mohs Surgery as the Standard of Care for Nail Unit Squamous Cell Carcinoma No abstract available |
How Wide Should the Excision Margins for Facial Small Aggressive Basal Cell Carcinoma Be? Experience With 306 Cases BACKGROUND Subclinical extension (SCE) of basal cell carcinomas (BCCs) may be responsible for incomplete resection of the tumor. The aggressive histological patterns (micronodular, infiltrative, and morpheaform) have greater tendencies toward invading surrounding tissues in an irregular pattern. OBJECTIVE To determine the SCE of small facial aggressive BCCs excised using Mohs micrographic surgery (MMS). MATERIALS AND METHODS An observational case series study. Data of patients with facial BCCs with aggressive histological patterns, less than or equal to 6 mm in diameter in high risk site (H zone), and 10 mm in intermediate risk site (M zone), treated with MMS between January 2008 and December 2016, were included. RESULTS This study included 306 histologically confirmed lesions retrieved from 1,196 clinical records reviewed. Median size of tumors was 5.7 mm (interquartile range: 5–6 mm). Resection of the tumors using 2, 3, and 4 mm margins achieves complete excision of the lesion including the subclinical extension area in 73.9%, 94.4%, and 99% of cases, respectively. CONCLUSION The present study demonstrated that a 4-mm resection margin was enough to eradicate the lesion completely in 99% of cases of primary small facial BCCs with aggressive histological patterns. Address correspondence and reprint requests to: Santiago A. Ariza, Department of Dermatology, Hospital de San José, calle 10 # 18-75, Bogotá, 111411, Colombia, or e-mail: santiagoandresariza@gmail.com The authors have indicated no significant interest with commercial supporters. © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. |
Mohs Micrographic Surgery as the Standard of Care for Nail Unit Squamous Cell Carcinoma BACKGROUND There is no established standard of care for treatment of nail unit squamous cell carcinoma (SCC). OBJECTIVE The aim of the study is to further characterize the clinical characteristics and diagnostic considerations of nail unit SCC and to examine the outcomes of patients with nail unit SCC treated with Mohs micrographic surgery (MMS). MATERIALS AND METHODS A retrospective review was conducted of patients treated for nail unit SCC with MMS from January 1, 2006, to December 30, 2016. Demographic data were collected along with lesion characteristics, treatment characteristics, and follow-up results. RESULTS Forty-two cases of nail unit SCC were treated with MMS. Recurrences were observed in 3 patients (7.1%). Recurrent cases were treated with MMS. There were no cases of distant metastases, subsequent recurrence, or death. Two of 3 recurrences occurred in patients with histologic features of verruca vulgaris. CONCLUSION Mohs micrographic surgery provides an excellent cure rate for the treatment of nail unit SCC. This technique offers the greatest ability to achieve histological clearance while maximizing tissue sparing, thereby reducing unnecessary amputations and patient morbidity. Address correspondence and reprint requests to: Darlene Gou, MD, Department of Dermatology, University of Texas Southwestern Medical Center, Dallas, TX 75390, or e-mail: darlene.gou@gmail.com The authors have indicated no significant interest with commercial supporters. © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. |
Predictive Value of Sentinel Lymph Node Biopsy in Cutaneous Squamous Cell Carcinoma Based on the AJCC-8 and Brigham and Women's Hospital Staging Criteria BACKGROUND Recommendations on when to perform sentinel lymph node (SLN) biopsy in cutaneous squamous cell carcinoma (cSCC) are lacking despite the tumor's clear predilection for lymphatic spread. OBJECTIVE To analyze the frequency of SLN metastasis in published series of cSCC in the context of the eighth edition of the American joint Committee on Cancer (AJCC-8) and the Brigham and Women's Hospital (BWH) staging criteria. METHODS Systematic review of studies of patients with cSCC who underwent SLN biopsy that described biopsy results. RESULTS In total, 153 patients with 24 positive SLN biopsies (15.7%) were included. Based on the AJCC-8 criteria positivity rates in the T2 and T3 categories were 8.3% (1/12 patients) and 25% (8/32), respectively. Using the BWH system there were, 2/33 in category T2a (6.5%), and 5/17 in category T2b (29.8%). On applying the same criteria to tumors of the trunk and extremities the results were similar. CONCLUSION It would seem reasonable to recommend SLN biopsy for patients with AJCC-8 Stage T3+ disease or BWH Stage T2b/T3 disease. Both the AJCC-8 and the BWH systems would appear to be useful for staging cSCC of the trunk and extremities. Address correspondence and reprint requests to: Antonio Tejera-Vaquerizo, Servicio de Dermatología Instituto Dermatológico GlobalDerm, Calle Feria, 40, CP 14700, Palma del Río (Córdoba), Spain, or e-mail: antoniotejera@aedv.es Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.dermatologicsurgery.org). The authors have indicated no significant interest with commercial supporters. © 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved. |
Cutaneous Metastases in a Patient With Muir–Torre Syndrome No abstract available |
ΩτοΡινοΛαρυγγολόγος Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,00306932607174,
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00302841026182,
00306932607174,
alsfakia@gmail.com,
Anapafseos 5 Agios Nikolaos 72100 Crete Greece,
Medicine by Alexandros G. Sfakianakis
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