DOCSLIB.ORG

Maintenance Treatment for Acne Vulgaris

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Maintenance Treatment for Acne Vulgaris National Institute for Health and Care Excellence Final Acne vulgaris: management [I] Maintenance treatments for acne vulgaris NICE guideline number NG198 Evidence review underpinning recommendations 1.7.1 to 1.7.5 in the NICE guideline June 2021 Final These evidence reviews were developed by the National Guideline Alliance which is a part of the Royal College of Obstetricians and Gynaecologists DRAFT Error! No text of specified style in document. Disclaimer The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian. Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties. NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn. Copyright © NICE 2021. All rights reserved. Subject to Notice of rights. ISBN: DRAFT Contents Contents Maintenance treatment for acne vulgaris .......................................................................... 6 Review question ............................................................................................................. 6 Summary of the protocol ....................................................................................... 6 Methods and process ............................................................................................ 7 Clinical evidence ................................................................................................... 7 Summary of clinical studies included in the evidence review ................................. 8 Quality assessment of clinical studies included in the evidence review ............... 12 Economic evidence ............................................................................................. 13 Economic model .................................................................................................. 13 The committee’s discussion of the evidence ........................................................ 13 Recommendations supported by this evidence review ........................................ 15 References .......................................................................................................... 15 Appendices ........................................................................................................................ 17 Appendix A – Review protocol ...................................................................................... 17 Review protocol for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ..................................................................... 17 Appendix B – Literature search strategies .................................................................... 24 Literature search strategies for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ................................................ 24 Clinical search ..................................................................................................... 24 Economic search ................................................................................................. 36 Appendix C – Clinical evidence study selection ............................................................ 39 Clinical study selection for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ..................................................................... 39 Appendix D – Evidence tables ...................................................................................... 40 Evidence tables for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ..................................................................... 40 Appendix E – Forest plots............................................................................................. 55 Forest plots for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ..................................................................................... 55 Appendix F – GRADE tables ........................................................................................ 57 GRADE tables for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ..................................................................................... 57 Appendix G - Economic evidence study selection ........................................................ 71 Economic evidence study selection for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ...................... 71 4 DRAFT Contents Appendix H– Economic evidence tables ....................................................................... 72 Economic evidence tables for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ................................................ 72 Appendix I – Economic evidence profiles ..................................................................... 73 Economic evidence profiles for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ................................................ 73 Appendix J – Economic analysis .................................................................................. 74 Economic analysis for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ..................................................................... 74 Appendix K – Excluded studies .................................................................................... 75 Excluded clinical and economic studies for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? ...................... 75 Clinical studies .................................................................................................... 75 Economic studies .............................................................................................. 157 Appendix L – Research recommendations ................................................................. 158 Research recommendations for review question: What is the effectiveness of topical or oral pharmacological and physical interventions as maintenance treatment for acne vulgaris? .............................................. 158 5 DRAFT Maintenance treatment for acne vulgaris 1 Maintenance treatment for acne vulgaris 2 Review question 3 What is the effectiveness of topical or oral pharmacological and physical interventions as 4 maintenance treatment for acne vulgaris? 5 Introduction 6 For some people acne is a relapsing condition that once treated may recur. This review 7 sought to identify whether any treatment could be effectively used to maintain good 8 outcomes once other treatments (including oral isotretinoin) had been discontinued. 9 Summary of the protocol 10 Please see Table 1 for a summary of the Population, Intervention, Comparison and Outcome 11 (PICO) characteristics of this review. 12 Table 1: Summary of the protocol Population People of all ages whose acne is ‘in remission’, have had their acne treated successfully, or whose acne has responded to treatment. Intervention • Topical treatments including abrasive/cleaning agents, anthelmintics, antibacterials, antibiotics, antiseptics, dicarboxylic acids, vitamin B3, retinoids or retinoid-like agents, or any combination of these. • Oral antibiotics including, for example, carbapenems, cephamycins/cephalosporins, sulphones, fucidic acid, lincosamides, macrolides, monobactams, penicillins, or any combination of these. • Oral isotretinoin. • Hormonal treatments including (monophasic and phasic) progestogen-only contraceptives, co-cyprindiol,
Load more

Recommended publications
  • Centre for Reviews and Dissemination
    Management of acne Lehmann H P, Andrews J S, Robinson K A, Holloway V L, Goodman S N Authors' objectives To provide a comprehensive review on the management of acne. Searching The search utilised several electronic databases from inception to 1999, including the CENTRAL Register in the Cochrane Library, MEDLINE, OLDMEDLINE (from 1960 to 1965), EMBASE, CINAHL and PsycINFO amongst others. Details of the searches were given in the report. In addition, the reference lists from key articles were checked and key experts were consulted. Only full articles published in English were eligible for the review. Study selection Study designs of evaluations included in the review Only randomised controlled trials (RCTs) or quasi-RCTs were considered for the review. There were 259 (94%) studies of a parallel-group design, 15 (5%) crossover, 30 (11%) 'split-face', and 22 (8%) parallel studies with matched controls. Specific interventions included in the review Studies of first-, second- and third-line treatments for acne were eligible for inclusion in the review. The included studies were of 140 different treatments, which were classified as: cleansers, keratolytics, topical antibacterials, keratolytic/topical antibacterial combinations, topical retinoids, topical antibacterial/retinoid combinations, oral antibacterials, oral antibacterial/keratolytics, oral antibacterial/topical retinoids, oral retinoids, anti-androgens and other. All individual treatments are listed in the review. No single control intervention was specified as an inclusion criterion; 250 different pairwise comparisons were included in the review. Participants included in the review Patients with acne were included in the review. Studies of patients with complicating co-morbidities such as endocrinopathies, and specifically, chloracne, rosacea, acne venanta, acne fulminans and acne necroticans, were excluded.
    [Show full text]
  • California Essential Drug List
    California Essential Drug List The Essential Drug List (formulary) includes a list of drugs covered by Health Net. The drug list is updated at least monthly and is subject to change. All previous versions are no longer in effect. You can view the most current drug list by going to our website at www.healthnet.com. Refer to Evidence of Coverage or Certificate of Insurance for specific cost share information. For California Individual & Family Plans: Drug Lists Select Health Net Large Group – Formulary (pdf). For Small Business Group: Drug Lists Select Health Net Small Business Group – Formulary (pdf). NOTE: To search the drug list online, open the (pdf) document. Hold down the “Control” (Ctrl) and “F” keys. When the search box appears, type the name of your drug and press the “Enter” key. If you have questions or need more information call us toll free. California Individual & Family Plans (off-Exchange) If you have questions about your pharmacy coverage call Customer Service at 1-800-839-2172 California Individual & Family Plans (on-Exchange) If you have questions about your pharmacy coverage call Customer Service at 1-888-926-4988 Hours of Operation 8:00am – 7:00pm Monday through Friday 8:00am – 5:00pm Saturday Small Business Group If you have questions about your pharmacy coverage call Customer Service at 1-800-361-3366 Hours of Operation 8:00am – 6:00pm Monday through Friday Updated September 1, 2021 Health Net of California, Inc. and Health Net Life Insurance Company are subsidiaries of Health Net, LLC and Centene Corporation. Health Net is a registered service mark of Health Net, LLC Table of Contents What If I Have Questions Regarding My Pharmacy Benefit? ...................................
    [Show full text]
  • B-Lactams: Chemical Structure, Mode of Action and Mechanisms of Resistance
    b-Lactams: chemical structure, mode of action and mechanisms of resistance Ru´ben Fernandes, Paula Amador and Cristina Prudeˆncio This synopsis summarizes the key chemical and bacteriological characteristics of b-lactams, penicillins, cephalosporins, carbanpenems, monobactams and others. Particular notice is given to first-generation to fifth-generation cephalosporins. This review also summarizes the main resistance mechanism to antibiotics, focusing particular attention to those conferring resistance to broad-spectrum cephalosporins by means of production of emerging cephalosporinases (extended-spectrum b-lactamases and AmpC b-lactamases), target alteration (penicillin-binding proteins from methicillin-resistant Staphylococcus aureus) and membrane transporters that pump b-lactams out of the bacterial cell. Keywords: b-lactams, chemical structure, mechanisms of resistance, mode of action Historical perspective Alexander Fleming first noticed the antibacterial nature of penicillin in 1928. When working with Antimicrobials must be understood as any kind of agent another bacteriological problem, Fleming observed with inhibitory or killing properties to a microorganism. a contaminated culture of Staphylococcus aureus with Antibiotic is a more restrictive term, which implies the the mold Penicillium notatum. Fleming remarkably saw natural source of the antimicrobial agent. Similarly, under- the potential of this unfortunate event. He dis- lying the term chemotherapeutic is the artificial origin of continued the work that he was dealing with and was an antimicrobial agent by chemical synthesis [1]. Initially, able to describe the compound around the mold antibiotics were considered as small molecular weight and isolates it. He named it penicillin and published organic molecules or metabolites used in response of his findings along with some applications of penicillin some microorganisms against others that inhabit the same [4].
    [Show full text]
  • Who Expert Committee on Specifications for Pharmaceutical Preparations
    WHO Technical Report Series 902 WHO EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS A Thirty-sixth Report aA World Health Organization Geneva i WEC Cover1 1 1/31/02, 6:35 PM The World Health Organization was established in 1948 as a specialized agency of the United Nations serving as the directing and coordinating authority for international health matters and public health. One of WHO’s constitutional functions is to provide objective and reliable information and advice in the field of human health, a responsibility that it fulfils in part through its extensive programme of publications. The Organization seeks through its publications to support national health strat- egies and address the most pressing public health concerns of populations around the world. To respond to the needs of Member States at all levels of development, WHO publishes practical manuals, handbooks and training material for specific categories of health workers; internationally applicable guidelines and standards; reviews and analyses of health policies, programmes and research; and state-of-the-art consensus reports that offer technical advice and recommen- dations for decision-makers. These books are closely tied to the Organization’s priority activities, encompassing disease prevention and control, the development of equitable health systems based on primary health care, and health promotion for individuals and communities. Progress towards better health for all also demands the global dissemination and exchange of information that draws on the knowledge and experience of all WHO’s Member countries and the collaboration of world leaders in public health and the biomedical sciences. To ensure the widest possible availability of authoritative information and guidance on health matters, WHO secures the broad international distribution of its publica- tions and encourages their translation and adaptation.
    [Show full text]
  • (12) United States Patent (10) Patent No.: US 9,713,596 B2 Hong Et Al
    USOO9713596B2 (12) United States Patent (10) Patent No.: US 9,713,596 B2 Hong et al. (45) Date of Patent: Jul. 25, 2017 (54) BAKUCHOL COMPOSITIONS FOR FOREIGN PATENT DOCUMENTS TREATMENT OF POST INFLAMMATORY DE 1900 435 7, 1970 HYPERPGMENTATION DE 3417234 A1 * 11, 1985 JP H1171231 A * 3, 1999 ............... A61K 7.00 (75) Inventors: Mei Feng Hong, Lacey, WA (US); Qi JP 2000-327581 A 11 2000 Jia, Olympia, WA (US); Lidia Alfaro JP 2005325 120 A 11/2005 KR 2000-0007648 A 2, 2000 Brownell, Tacoma, WA (US) WO 2006/122160 A2 11/2006 WO 2008. 140673 A1 11, 2008 (73) Assignee: Unigen, Inc., Lacey, WA (US) (*) Notice: Subject to any disclaimer, the term of this OTHER PUBLICATIONS patent is extended or adjusted under 35 Ohno, O. Watabe, T., Kazuhiko, N., Kawagoshi, M., Uotsu, N., U.S.C. 154(b) by 0 days. Chiba, T., Yamada, M., Yamaguchi, K., Yamada, K., Miyamoto, K., Uemura, D. Inhibitory Effects of Bakuchiol, Bavachin, an (21) Appl. No.: 13/365,172 Isobavachalcone Isolated from Piper loungum on Melainin Produc (22) Filed: Feb. 2, 2012 tion in B 16 Mouse Melanoma Cells. Biosci. Biotechnol. Biochem. 74 (7), 1504-1506 (2010).* Prior Publication Data Hiroyuki Haraguchi, Junji Inoue, Yukiyoshi Tamura and Kenji (65) Mizutani.Antioxidative Components of Psoralea corylifolia US 2012/O2O1769 A1 Aug. 9, 2012 (Leguminosae). Phytother. Res. 16, 539-544 (2002).* Petra Clara Arck, et al. Towards a “free radical theory of graying: melanocyte apoptosis in the aging human hair follicle is an indicator Related U.S. Application Data of oxidative stress induced tissue damage.
    [Show full text]
  • Title Antimicrobial Therapy for Acute Cholecystitis: Tokyo Guidelines
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by HKU Scholars Hub Title Antimicrobial therapy for acute cholecystitis: Tokyo Guidelines Yoshida, M; Takada, T; Kawarada, Y; Tanaka, A; Nimura, Y; Gomi, H; Hirota, M; Miura, F; Wada, K; Mayumi, T; Solomkin, JS; Author(s) Strasberg, S; Pitt, HA; Belghiti, J; de Santibanes, E; Fan, ST; Chen, MF; Belli, G; Hilvano, SC; Kim, SW; Ker, CG Journal Of Hepato-Biliary-Pancreatic Surgery, 2007, v. 14 n. 1, p. Citation 83-90 Issued Date 2007 URL http://hdl.handle.net/10722/84203 Rights J Hepatobiliary Pancreat Surg (2007) 14:83–90 DOI 10.1007/s00534-006-1160-y Antimicrobial therapy for acute cholecystitis: Tokyo Guidelines Masahiro Yoshida1, Tadahiro Takada1, Yoshifumi Kawarada2, Atsushi Tanaka3, Yuji Nimura4, Harumi Gomi5, Masahiko Hirota6, Fumihiko Miura1, Keita Wada1, Toshihiko Mayumi7, Joseph S. Solomkin8, Steven Strasberg9, Henry A. Pitt10, Jacques Belghiti11, Eduardo de Santibanes12, Sheung-Tat Fan13, Miin-Fu Chen14, Giulio Belli15, Serafin C. Hilvano16, Sun-Whe Kim17, and Chen-Guo Ker18 1 Department of Surgery, Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan 2 Mie University School of Medicine, Mie, Japan 3 Department of Medicine, Teikyo University School of Medicine, Tokyo, Japan 4 Division of Surgical Oncology, Department of Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan 5 Division of Infection Control and Prevention, Jichi Medical University Hospital, Tochigi, Japan 6 Department of Gastroenterological
    [Show full text]
  • This Works My Wrinkles CBD Booster 004417
    Laboratory Test Report Report Number: R-2020-753-724 Page 1 of 1 Prepared for: This Works Products Ltd Address: 53 St Georges Road Wimbledon SW19 4EA Customer Sample Description: My Wrinkles CBD Booster + Bakuchiol GWOR648/GWOR649 004417 Eurofins Registration Number: 7500 / 2020-753-724 No. of samples: 1 Test(s) Performed: Cannabinoid Quantification and Density measurement for CBD profiling Date Received: 21/02/2020 Date(s) Tested: 24/02/2020 – 28/02/2020 Results and Observations Please refer to the following page(s) _________________ Christine Dee (Analytical Services Manager) Date: 04/03/2020 The reported results relate exclusively to the tested sample. The testing was performed by a laboratory within the Eurofins Group. Eurofins Product Testing Services Limited Registered Office: Unit 16, Willan Trading Estate, Waverley Road i54 Business Park, Valiant Way Sale, M33 7AY Wolverhampton, WV9 5GB Tel: +44 (0)161 868 7600 Registration Number: 7401660 Fax: +44 (0)161 868 7699 Vat Number: 887 1276 83 Report Number: 2803666-0 Report Date: 04-Mar-2020 Report Status: Final Certificate of Analysis Eurofins Product Testing Services Limited UNIT 16, WILLAN TRADING ESTATE, WAVERLEY ROAD Sale M33 7AY Sample Name: My Wrinkles CBD Booster Plus Eurofins Sample: 9302398 Bakuchiol Project ID EURO_HAR-20200224-0033 Receipt Date 24-Feb-2020 PO Number CVD Receipt Condition Ambient temperature Lot Number 2020-753-724 Login Date 24-Feb-2020 Sample Serving Size Date Started 28-Feb-2020 Sampled Sample results apply as received Online Order 20 Analysis Result
    [Show full text]
  • NG198 Evidence Review F2
    FINAL Management options for moderate to severe acne – pairwise comparisons GRADE tables for review question: What is the effectiveness and acceptability of interventions for the treatment of moderate to severe acne (side effects and participant reported improvement)? Oral antibiotics Table 5: Clinical evidence profile for comparison of oral antibiotic versus placebo in participants with moderate to severe acne Quality assessment No of patients Effect Importanc Quality e No of Risk of Other Oral Placeb Relative Design Inconsistency Indirectness Imprecision Absolute studies bias considerations antibiotic o (95% CI) Skin irritation - Minocycline versus placebo 11 randomised serious7 no serious no serious very serious8 none 5/119 1/55 RR 2.31 (0.28 to 24 more per 1000 (from 13 ⊕ΟΟΟ CRITICAL trials inconsistency indirectness (4.2%) (1.8%) 19.31) fewer to 333 more) VERY LOW GI side effects 51,2,3,4,5 randomised very serious10 no serious very serious8 none 82/1543 41/1177 RR 1.11 (0.62 to 4 more per 1000 (from 13 ⊕ΟΟΟ CRITICAL trials serious9 indirectness (5.3%) (3.5%) 2) fewer to 35 more) VERY LOW Thrush / candiasis - Sarecyline versus placebo 24,5 randomised serious7 no serious no serious serious11 none 4/994 0/996 Peto OR 7.44 - ⊕⊕ΟΟ CRITICAL trials inconsistency indirectness (0.4%) (0%) (1.05 to 52.86) LOW Patient reported improvement - Tetracycline versus placebo 16 randomised very no serious no serious no serious none 21/29 1/29 RR 21 (3.02 to 690 more per 1000 (from ⊕⊕ΟΟ CRITICAL trials serious9 inconsistency indirectness imprecision (72.4%) (3.4%) 145.98) 70 more to 1000 more) LOW CI: confidence interval; GI: gastrointestinal; POR: peto odds ratio; RR: risk ratio 1 Stewart 2006 Acne vulgaris: evidence reviews for management options for moderate to severe acne – pairwise comparisons FINAL (June 2021) 143 FINAL Management options for moderate to severe acne – pairwise comparisons 2 Dubertret 2003 3 Leyden 2018 4 Moore 2018 (SC1401) 5 Moore 2018 (SC1402) 6 Braathen 1984 7 Overall risk of bias judgement: serious risk of bias.
    [Show full text]
  • (12) Patent Application Publication (10) Pub. No.: US 2011/0136210 A1 Benjamin Et Al
    US 2011013621 OA1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2011/0136210 A1 Benjamin et al. (43) Pub. Date: Jun. 9, 2011 (54) USE OF METHYLSULFONYLMETHANE Publication Classification (MSM) TO MODULATE MICROBIAL ACTIVITY (51) Int. Cl. CI2N 7/06 (2006.01) (75) Inventors: Rodney L. Benjamin, Camas, WA CI2N I/38 (2006.01) (US); Jeffrey Varelman, Moyie (52) U.S. Cl. ......................................... 435/238; 435/244 Springs, ID (US); Anthony L. (57) ABSTRACT Keller, Ashland, OR (US) Disclosed herein are methods of use of methylsulfonyl (73) Assignee: Biogenic Innovations, LLC methane (MSM) to modulate microbial activity, such as to enhance or inhibit the activity of microorganisms. In one (21) Appl. No.: 13/029,001 example, MSM (such as about 0.5% to 5% MSM) is used to enhance fermentation efficiency. Such as to enhance fermen (22) Filed: Feb. 16, 2011 tation efficiency associated with the production of beer, cider, wine, a biofuel, dairy product or any combination thereof. Related U.S. Application Data Also disclosed are in vitro methods for enhancing the growth of one or more probiotic microorganisms and methods of (63) Continuation of application No. PCT/US2010/ enhancing growth of a microorganism in a diagnostic test 054845, filed on Oct. 29, 2010. sample. Methods of inhibiting microbial activity are also disclosed. In one particular example, a method of inhibiting (60) Provisional application No. 61/294,437, filed on Jan. microbial activity includes selecting a medium that is suscep 12, 2010, provisional application No. 61/259,098, tible to H1N1 influenza contamination; and contacting the filed on Nov.
    [Show full text]
  • United States Patent 19 11 Patent Number: 5,668,134 Klimstra Et Al
    US.005668134A United States Patent 19 11 Patent Number: 5,668,134 Klimstra et al. (45) Date of Patent: Sep. 16, 1997 54 METHOD FOR PREVENTING OR Keiichi Tozawa, et al. "AClinical Study of Lomefloxacin on REDUCNG PHOTOSENSTIWTY AND/OR Patients with Urinary Tract Infections. Focused on Lom PHOTOTOXCTY REACTIONS TO efloxacin-induced photosensitivity reaction”. Acta Urol. MEDCATIONS Jpn., vol.39, pp. 801-805. (1993) *(English translation of Japanese article is attached). 75 Inventors: Paul Dale Klimstra, Northbrook; Pierre Treffel, et al. "Chronopharmacokinetics of 5-Meth Barbara Roniker, Chicago; Edward oxypsoralen'", Acta Derm. Venerol, vol. 70, No. 6, pp. Allen Swabb, Kenilworth, all of Ill. 515-517, (1990). (73) Assignee: G. D. Searle & Co., Chicago, Ill. Primary Examiner-James H. Reamer Attorney, Agent, or Firm-Roberta L. Hastreiter; Roger A. 21) Appl. No.: 188,296 Williams 22 Filed: Jan. 28, 1994 57 ABSTRACT (51 Int. Cl. ... A61K 31/395 The present invention provides a method for preventing or 52 U.S. Cl. .............................................................. 514/254 reducing a photosensitivity and/or phototoxicity reaction which may be caused by a once-per-day dose of a medica 581 Field of Search ........................................ 514/254 tion which causes a photosensitivity and/or phototoxicity 56) References Cited reaction in a patient comprising administering the prescribed or suggested dose of the medication to the patient during the U.S. PATENT DOCUMENTS evening or early morning hours. 4,528,287 7/1985 Itoh et al. ............................... 514/254 The present invention also provides an article of manufac OTHER PUBLICATIONS ture comprising: (1) a packaging material, and (2) a once a-day dose medication which causes a photosensitivity and/ Bowee et al, Abstract of J.A.
    [Show full text]
  • Different Antibiotic Treatments for Group a Streptococcal Pharyngitis (Review)
    Different antibiotic treatments for group A streptococcal pharyngitis (Review) van Driel ML, De Sutter AIM, Keber N, Habraken H, Christiaens T This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2010, Issue 10 http://www.thecochranelibrary.com Different antibiotic treatments for group A streptococcal pharyngitis (Review) Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 BACKGROUND .................................... 2 OBJECTIVES ..................................... 3 METHODS ...................................... 3 RESULTS....................................... 5 DISCUSSION ..................................... 8 AUTHORS’CONCLUSIONS . 11 ACKNOWLEDGEMENTS . 11 REFERENCES ..................................... 12 CHARACTERISTICSOFSTUDIES . 16 DATAANDANALYSES. 43 Analysis 1.1. Comparison 1 Cephalosporin versus penicillin, Outcome 1 Resolution of symptoms post-treatment (ITT analysis). ................................... 45 Analysis 1.2. Comparison 1 Cephalosporin versus penicillin, Outcome 2 Resolution of symptoms post-treatment (evaluable participants)................................... 46 Analysis 1.3. Comparison 1 Cephalosporin versus penicillin, Outcome 3 Resolution of symptoms within 24 hours of treatment(ITTanalysis).. 47 Analysis 1.4. Comparison 1 Cephalosporin versus penicillin, Outcome
    [Show full text]
  • Next Generation Risk Assessment of Human Exposure to Anti-Androgens Using Newly Defined Comparator Compound Values
    Toxicology in Vitro 73 (2021) 105132 Contents lists available at ScienceDirect Toxicology in Vitro journal homepage: www.elsevier.com/locate/toxinvit Next generation risk assessment of human exposure to anti-androgens using newly defined comparator compound values Tessa C.A. van Tongeren a,*, Thomas E. Moxon b, Matthew P. Dent b, Hequn Li b, Paul L. Carmichael b, Ivonne M.C.M. Rietjens a a Division of Toxicology, Wageningen University and Research, 6700, EA, Wageningen, the Netherlands b Unilever Safety and Environmental Assurance Centre, Colworth Science Park, Sharnbrook, Bedfordshire MK44 1LQ, UK ARTICLE INFO ABSTRACT Keywords: Next Generation Risk Assessment (NGRA) can use the so-called Dietary Comparator Ratio (DCR) to evaluate the Risk assessment safety of a definedexposure to a compound of interest. The DCR compares the Exposure Activity Ratio (EAR) for 3R compliant method the compound of interest, to the EAR of an established safe level of human exposure to a comparator compound Androgen receptor with the same putative mode of action. A DCR ≤ 1 indicates the exposure evaluated is safe. The present study Dietary comparator aimed at defining adequate and safe comparator compound exposures for evaluation of anti-androgenic effects, In vitro/in silico approaches using 3,3-diindolylmethane (DIM), from cruciferous vegetables, and the anti-androgenic drug bicalutamide (BIC). EAR values for these comparator compounds were definedusing the AR-CALUX assay. The adequacy of the new comparator EAR values was evaluated using PBK modelling and by comparing the generated DCRs of a series of test compound exposures to actual knowledge on their safety regarding in vivo anti-androgenicity.
    [Show full text]