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/></a></div><div class="bkr_bib"><h1 id="_NBK573053_"><span itemprop="name">Management options for people with acne vulgaris and polycystic ovary syndrome</span></h1><div class="subtitle">Acne vulgaris: management</div><p><b>Evidence review G</b></p><p><i>NICE Guideline, No. 198</i></p><p class="contrib-group"><h4>Authors</h4><span itemprop="author">National Guideline Alliance (UK)</span>.</p><div class="half_rhythm">London: <a href="https://www.nice.org.uk" ref="pagearea=meta&targetsite=external&targetcat=link&targettype=publisher"><span itemprop="publisher">National Institute for Health and Care Excellence (NICE)</span></a>; <span itemprop="datePublished">2021 Jun</span>.<div class="small">ISBN-13: <span itemprop="isbn">978-1-4731-4147-6</span></div></div><div><a href="/books/about/copyright/">Copyright</a> © NICE 2021.</div></div><div class="bkr_clear"></div></div><div id="niceng198er9.s1"><h2 id="_niceng198er9_s1_">Management options for people with acne vulgaris and polycystic ovary syndrome</h2><div id="niceng198er9.s1.1"><h3>Review question</h3><p>What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</p><div id="niceng198er9.s1.1.1"><h4>Introduction</h4><p>Acne in people with confirmed polycystic ovarian syndrome may be exacerbated by hyperadrogenism potentially resulting in persistent or recurrent acne. This review therefore explores treatment options for this group of people separately as certain therapies, for example anti-androgens, may be more relevant compared to people without polycystic ovarian syndrome (who are covered in evidence reviews E1/E2 and F1/F2).</p></div><div id="niceng198er9.s1.1.2"><h4>Summary of the protocol</h4><p>See <a class="figpopup" href="/books/NBK573053/table/niceng198er9.tab1/?report=objectonly" target="object" rid-figpopup="figniceng198er9tab1" rid-ob="figobniceng198er9tab1">Table 1</a> for a summary of the Population, Intervention, Comparison and Outcome (PICO) characteristics of this review.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng198er9tab1"><a href="/books/NBK573053/table/niceng198er9.tab1/?report=objectonly" target="object" title="Table 1" class="img_link icnblk_img figpopup" rid-figpopup="figniceng198er9tab1" rid-ob="figobniceng198er9tab1"><img class="small-thumb" src="/books/NBK573053/table/niceng198er9.tab1/?report=thumb" src-large="/books/NBK573053/table/niceng198er9.tab1/?report=previmg" alt="Table 1. Summary of the protocol." /></a><div class="icnblk_cntnt"><h4 id="niceng198er9.tab1"><a href="/books/NBK573053/table/niceng198er9.tab1/?report=objectonly" target="object" rid-ob="figobniceng198er9tab1">Table 1</a></h4><p class="float-caption no_bottom_margin">Summary of the protocol. </p></div></div><p>For further details see the review protocol in <a href="#niceng198er9.appa">appendix A</a>.</p></div><div id="niceng198er9.s1.1.3"><h4>Methods and process</h4><p>This evidence review was developed using the methods and process described in <a href="https://www.nice.org.uk/process/pmg20/chapter/introduction" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Developing NICE guidelines: the manual</a>. Methods specific to this review question are described in the review protocol in <a href="#niceng198er9.appa">appendix A</a> and the <a href="/books/NBK573053/bin/niceng198er9_bm1.pdf">methods</a> document (supplementary document 1).</p><p>Declarations of interest were recorded according to <a href="https://www.nice.org.uk/about/who-we-are/policies-and-procedures" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">NICE’s conflicts of interest policy</a>.</p></div><div id="niceng198er9.s1.1.4"><h4>Clinical evidence</h4><div id="niceng198er9.s1.1.4.1"><h5>Included studies</h5><p>Overall 4 randomised controlled trials (RCTs) were included for this review (<a class="bibr" href="#niceng198er9.s1.1.ref1" rid="niceng198er9.s1.1.ref1">Colonna 2012</a>, <a class="bibr" href="#niceng198er9.s1.1.ref2" rid="niceng198er9.s1.1.ref2">Hagag 2014</a>, <a class="bibr" href="#niceng198er9.s1.1.ref3" rid="niceng198er9.s1.1.ref3">Leelaphiwat 2015</a>, and <a class="bibr" href="#niceng198er9.s1.1.ref4" rid="niceng198er9.s1.1.ref4">Podfigurna 2020</a>).</p><p>The included studies are summarised in <a class="figpopup" href="/books/NBK573053/table/niceng198er9.tab2/?report=objectonly" target="object" rid-figpopup="figniceng198er9tab2" rid-ob="figobniceng198er9tab2">Table 2</a>.</p><p>Two studies compared ethinylestradiol and drospirenone to ethinylestradiol and chlormadinone (<a class="bibr" href="#niceng198er9.s1.1.ref1" rid="niceng198er9.s1.1.ref1">Colonna 2012</a>, <a class="bibr" href="#niceng198er9.s1.1.ref4" rid="niceng198er9.s1.1.ref4">Podfigurna 2020</a>); 1 study conducted a 3 arm trial which compared norgestimate, ethinylestradiol, and spironolactone, to cyproterone acetate and ethinylestradiol, and to norgestimate and ethinylestradiol (<a class="bibr" href="#niceng198er9.s1.1.ref2" rid="niceng198er9.s1.1.ref2">Hagag 2014</a>); and 1 study compared ethinylestradiol, desogestrel, and spironolactone to ethinylestradiol and cyproterone acetate (<a class="bibr" href="#niceng198er9.s1.1.ref3" rid="niceng198er9.s1.1.ref3">Leelaphiwat 2015</a>).</p><p>See the literature search strategy in <a href="#niceng198er9.appb">appendix B</a> and study selection flow chart in <a href="#niceng198er9.appc">appendix C</a>.</p></div><div id="niceng198er9.s1.1.4.2"><h5>Excluded studies</h5><p>Studies not included in this review are listed, and reasons for their exclusion are provided in <a href="#niceng198er9.appk">appendix K</a>.</p></div></div><div id="niceng198er9.s1.1.5"><h4>Summary of studies included in the evidence review</h4><p>Summaries of the studies that were included in this review are presented in <a class="figpopup" href="/books/NBK573053/table/niceng198er9.tab2/?report=objectonly" target="object" rid-figpopup="figniceng198er9tab2" rid-ob="figobniceng198er9tab2">Table 2</a>.</p><div class="iconblock whole_rhythm clearfix ten_col table-wrap" id="figniceng198er9tab2"><a href="/books/NBK573053/table/niceng198er9.tab2/?report=objectonly" target="object" title="Table 2" class="img_link icnblk_img figpopup" rid-figpopup="figniceng198er9tab2" rid-ob="figobniceng198er9tab2"><img class="small-thumb" src="/books/NBK573053/table/niceng198er9.tab2/?report=thumb" src-large="/books/NBK573053/table/niceng198er9.tab2/?report=previmg" alt="Table 2. Summary of included studies." /></a><div class="icnblk_cntnt"><h4 id="niceng198er9.tab2"><a href="/books/NBK573053/table/niceng198er9.tab2/?report=objectonly" target="object" rid-ob="figobniceng198er9tab2">Table 2</a></h4><p class="float-caption no_bottom_margin">Summary of included studies. </p></div></div><p>See the full evidence tables in <a href="#niceng198er9.appd">appendix D</a> and the forest plots in <a href="#niceng198er9.appe">appendix E</a>.</p></div><div id="niceng198er9.s1.1.6"><h4>Quality assessment of studies included in the evidence review</h4><p>See the evidence profiles in <a href="#niceng198er9.appf">appendix F</a>.</p></div><div id="niceng198er9.s1.1.7"><h4>Economic evidence</h4><div id="niceng198er9.s1.1.7.1"><h5>Included studies</h5><p>A single economic search was undertaken for all topics included in the scope of this guideline but no economic studies were identified which were applicable to this review question. See the literature search strategy in <a href="#niceng198er9.appb">appendix B</a> and economic study selection flow chart in <a href="#niceng198er9.appg">appendix G</a>.</p></div><div id="niceng198er9.s1.1.7.2"><h5>Excluded studies</h5><p>Economic studies not included in this review are listed, and reasons for their exclusion are provided, in <a href="#niceng198er9.appk">appendix K</a>.</p></div></div><div id="niceng198er9.s1.1.8"><h4>Economic model</h4><p>No economic modelling was conducted for this review question, because the committee agreed that other topics were higher priorities for economic evaluation.</p></div><div id="niceng198er9.s1.1.9"><h4>The committee’s discussion of the evidence</h4><div id="niceng198er9.s1.1.9.1"><h5>Interpreting the evidence</h5><div id="niceng198er9.s1.1.9.1.1"><h5>The outcomes that matter most</h5><p>Clinician rated and participant rated improvement of acne were prioritised by the committee as critical outcomes because they indicate the effectiveness of any treatment option. Prevention of scarring was another critical outcome due to its lasting negative impact on self-esteem and psychological wellbeing. Discontinuation of treatment and discontinuation due to side effects as well as individual side effects (within each class) were important outcomes because they indicate how well a treatment is tolerated. Relapse was also an important outcome because it indicates how long a treatment may be effective.</p></div><div id="niceng198er9.s1.1.9.1.2"><h5>The quality of the evidence</h5><p>There was only evidence about hormonal treatments – none of the other interventions of interest were reported in the subgroup of people with polycystic ovary syndrome and acne. Of the outcomes of interest, only clinician-rated improvement was reported.</p><p>The quality of the evidence as assessed by GRADE ranged from low to very low quality. Evidence about clinician-rated improvement was downgraded due to risk of bias and imprecision around the effect estimate.</p></div><div id="niceng198er9.s1.1.9.1.3"><h5>Benefits and harms</h5><p>There was insufficient evidence to identify the most effective treatment for acne vulgaris in people with polycystic ovary syndrome. This was due to the limited number of studies as well as the limited number of treatment options that were investigated in the identified evidence. So the committee based their recommendations on knowledge and experience. They agreed that standard first line care options are appropriate in the first instance. The committee thought it was important that people with polycystic ovary syndrome were not treated differently to other people in initial care, where there is evidence of effective first line care options. This would also enable treatment for acne to be started without any delays associated with the diagnosis of polycystic ovary syndrome.</p><p>If standard first line options do not work, the committee agreed, based on their knowledge and experience that adding one of the 2 hormonal treatments such as ethinylestradiol with cyproterone (co-cyprindiol) or an alternative combined oral contraceptive pill could be used due to their known effectiveness in treating hyperandrogenism which is the defining feature in people with polycystic ovary syndrome. The committee agreed that co-cyprindiol is a hormonal treatment option because it has a different mechanism of action to alternative combined oral contraceptives and, based on the committee’s knowledge, is also known to be effective in the treatment of hyperandrogenism. The committee agreed the combined oral contraceptive pill is an established and widely available hormonal treatment that is used to treat symptoms of polycystic ovary syndrome. While there was some evidence comparing different hormonal treatments against each other, the committee agreed that the choice of combined oral contraceptive pill should be based on a discussion of benefits and harms of the various combined hormonal contraceptive pill options available.</p><p>The committee thought that a 6-month review for those using co-cyprindiol would be needed to decide whether treatment needs to be changed, to avoid prolonging ineffective treatment and to avoid side-effects associated with its long-term use. It was discussed based on expertise that people requiring co-cyprindiol may have an inherently increased risk of cardiovascular disease and that longer term usasge should therefore be considered with caution.</p><p>The committee agreed that the standard first line treatment options as well as the combined contraceptive pill and co-cyprindiol could be delivered in primary care but some people with acne vulgaris and polycystic ovary syndrome who have additional features of hyperandrogenism (for example a high degree of hirsutism) which can cause significant psychological distress, would require more specialist treatment and would benefit from referral to a specialist, such a reproductive endocrinologist.</p><p>Due to the small number of studies identified, the committee prioritised this topic for further research to increase the evidence base to inform future updates (see <a href="#niceng198er9.appl">appendix L</a>).</p></div></div><div id="niceng198er9.s1.1.9.2"><h5>Cost effectiveness and resource use</h5><p>No economic evidence on the cost effectiveness of management options for people with polycystic ovary syndrome and acne vulgaris was identified. The recommendation to treat acne in this population using first line care options in the first instance, which were shown to be clinically and cost-effective in people with acne vulgaris according to the guideline network meta-analysis and economic analysis, likely comprises efficient use of resources, although it was acknowledged that the available clinical and economic evidence was not specific to people with polycystic ovary syndrome and acne vulgaris. The committee expressed the opinion that adding the combined oral contraceptive pill to first line treatment, if the latter is not effective, may result in health benefits relating to the management of both acne and polycystic ovary syndrome symptoms, and has small resource implications as the drug acquisition and the extra monitoring costs of the combined oral contraceptive pill are rather low. The same opinion regarding benefits and costs was expressed about the use of cyproterone acetate with ethinylestradiol, in case treatment with the combined oral contraceptive pill is not desired or is ineffective. The committee agreed that reviewing treatment after 6 months in order to decide whether to continue or change treatment ensured efficient use of resources, as it avoided prolonging use of ineffective treatment. They also agreed that for some people with acne vulgaris and polycystic ovary syndrome who have features of hyperandrogenism, referral to appropriate specialist care may be beneficial. The committee was aware that referral to specialist care requires use of additional healthcare resources at extra cost, but decided to make a ‘consider’ recommendation based on their expertise because they expressed the view that benefits of referral to specialist care are likely to outweigh future costs incurred by more resource intensive management of symptoms further down the care pathway, that may be needed if people are not referred to a specialist.</p></div><div id="niceng198er9.s1.1.9.3"><h5>Other factors the committee took into account</h5><p>The committee were aware that sexual health advisory groups like the Faculty of Reproductive and Sexual Health offer <a href="https://www.fsrh.org/standards-and-guidance/documents/combined-hormonal-contraception" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">guidance</a> on contraindications, benefits and harms of various hormonal contraceptive pills which would inform shared decision making on the choice of these treatments.</p></div></div><div id="niceng198er9.s1.1.10"><h4>Recommendations supported by this evidence review</h4><p>This evidence review supports recommendations 1.5.28 and 1.5.29 and research recommendation 2 on treatment options for people with polycystic ovary syndrome.</p></div><div id="niceng198er9.s1.1.rl.r1"><h4>References</h4><ul class="simple-list"><li class="half_rhythm"><p><div class="bk_ref" id="niceng198er9.s1.1.ref1"><p id="p-102">
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<strong>Colonna 2012</strong>
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</p>Colonnao, L., Pacifico, V., Lello, S., Sorge, R., Raskovic, D., Primavera, G., Skin improvement with two different oestroprogestins in patients affected by acne and polycystic ovary syndrome: clinical and instrumental evaluation, Journal of the European Academy of Dermatology and Venereologoooy, 26, 1364–1371, 2012 [<a href="https://pubmed.ncbi.nlm.nih.gov/22011217" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 22011217</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng198er9.s1.1.ref2"><p id="p-103">
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<strong>Hagag 2014</strong>
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</p>Hagag, P., Steinschneider, M., Weiss, M., Role of the combination spironolactone-norgestimate-estrogen in hirsute women with polycystic ovary syndrome, The Journal of European Medicine, 59, 455–463, 2014 [<a href="https://pubmed.ncbi.nlm.nih.gov/25330687" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25330687</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng198er9.s1.1.ref3"><p id="p-104">
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<strong>Leelaphiwat 2015</strong>
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</p>Leelaphiwat, S., Jongwutiwes, T., Lertvikool, S., Tabcharoen, C., Sukprasert, M., Rattanasiri, S., Weerakiet, S., Comparison of desogestrel/ethinylestradiol plus spironolactone versus cyproterone acetate/ethinylestradiol in the treatment of polycystic ovary syndrome: A randomised controlled trial, The Journal of Obstetrics and Gynaecology Research, 41, 402–410, 2015 [<a href="https://pubmed.ncbi.nlm.nih.gov/25319761" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 25319761</span></a>]</div></p></li><li class="half_rhythm"><p><div class="bk_ref" id="niceng198er9.s1.1.ref4"><p id="p-105">
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<strong>Podfigurna 2020</strong>
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</p>Podfigurna, A., Meczekalski, B., Petraglia, F., Luisi, S., Clinical, hormonal and metabolic parameters in women with PCOS with different combined oral contraceptives (containing chlormadinone acetate versus drospirenone), Journal of Endocrinological Investigation, 43, 483–492, 2020 [<a href="/pmc/articles/PMC7067819/" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pmc">PMC free article<span class="bk_prnt">: PMC7067819</span></a>] [<a href="https://pubmed.ncbi.nlm.nih.gov/31654312" ref="pagearea=cite-ref&targetsite=entrez&targetcat=link&targettype=pubmed">PubMed<span class="bk_prnt">: 31654312</span></a>]</div></p></li></ul></div></div></div><div id="appendixesappgroup1"><h2 id="_appendixesappgroup1_">Appendices</h2><div id="niceng198er9.appa"><h3>Appendix A. Review protocol</h3><p id="niceng198er9.appa.et1"><a href="/books/NBK573053/bin/niceng198er9-appa-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Review protocol for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</a><span class="small"> (PDF, 300K)</span></p></div><div id="niceng198er9.appb"><h3>Appendix B. Literature search strategies</h3><p id="niceng198er9.appb.et1"><a href="/books/NBK573053/bin/niceng198er9-appb-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Literature search strategies for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</a><span class="small"> (PDF, 820K)</span></p></div><div id="niceng198er9.appc"><h3>Appendix C. Clinical evidence study selection</h3><p id="niceng198er9.appc.et1"><a href="/books/NBK573053/bin/niceng198er9-appc-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Study selection for: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</a><span class="small"> (PDF, 139K)</span></p></div><div id="niceng198er9.appd"><h3>Appendix D. Evidence tables</h3><p id="niceng198er9.appd.et1"><a href="/books/NBK573053/bin/niceng198er9-appd-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Evidence tables for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</a><span class="small"> (PDF, 232K)</span></p></div><div id="niceng198er9.appe"><h3>Appendix E. Forest plots</h3><p id="niceng198er9.appe.et1"><a href="/books/NBK573053/bin/niceng198er9-appe-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Forest plots for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</a><span class="small"> (PDF, 144K)</span></p></div><div id="niceng198er9.appf"><h3>Appendix F. GRADE tables</h3><p id="niceng198er9.appf.et1"><a href="/books/NBK573053/bin/niceng198er9-appf-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">GRADE tables for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</a><span class="small"> (PDF, 417K)</span></p></div><div id="niceng198er9.appg"><h3>Appendix G. Economic evidence study selection</h3><p id="niceng198er9.appg.et1"><a href="/books/NBK573053/bin/niceng198er9-appg-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Economic evidence study selection for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</a><span class="small"> (PDF, 187K)</span></p></div><div id="niceng198er9.apph"><h3>Appendix H. Economic evidence tables</h3><div id="niceng198er9.apph.s1"><h4>Economic evidence tables for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</h4><p>No economic evidence was identified which was applicable to this review question.</p></div></div><div id="niceng198er9.appi"><h3>Appendix I. Economic evidence profiles</h3><div id="niceng198er9.appi.s1"><h4>Economic evidence profiles for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</h4><p>No economic evidence was identified which was applicable to this review question.</p></div></div><div id="niceng198er9.appj"><h3>Appendix J. Economic analysis</h3><div id="niceng198er9.appj.s1"><h4>Economic evidence analysis for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</h4><p>No economic analysis was conducted for this review question.</p></div></div><div id="niceng198er9.appk"><h3>Appendix K. Excluded studies</h3><div id="niceng198er9.appk.s1"><h4>Excluded studies for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</h4></div><div id="niceng198er9.appk.s2"><h4>Clinical studies</h4><p id="niceng198er9.appk.et1"><a href="/books/NBK573053/bin/niceng198er9-appk-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (1.5M)</span></p></div><div id="niceng198er9.appk.s3"><h4>Economic studies</h4><p id="niceng198er9.appk.et2"><a href="/books/NBK573053/bin/niceng198er9-appk-et2.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Download PDF</a><span class="small"> (158K)</span></p></div></div><div id="niceng198er9.appl"><h3>Appendix L. Research recommendations</h3><p id="niceng198er9.appl.et1"><a href="/books/NBK573053/bin/niceng198er9-appl-et1.pdf" class="bk_dwnld_icn bk_dwnld_pdf">Research recommendations for review question: What is an effective management option for people with acne vulgaris and polycystic ovary syndrome (PCOS)?</a><span class="small"> (PDF, 178K)</span></p></div></div></div><div class="fm-sec"><div><p>Final</p></div><div><p>Evidence review underpinning recommendations 1.5.28 and 1.5.29 and research recommendation 2 in the NICE guideline</p><p>These evidence reviews were developed by the National Guideline Alliance which is a part of the Royal College of Obstetricians and Gynaecologists</p></div><div><p><b>Disclaimer</b>: 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.</p><p>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.</p><p>NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the <a href="http://wales.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Welsh Government</a>, <a href="http://www.scotland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Scottish Government</a>, and <a href="http://www.northernireland.gov.uk/" ref="pagearea=body&targetsite=external&targetcat=link&targettype=uri">Northern Ireland Executive</a>. All NICE guidance is subject to regular review and may be updated or withdrawn.</p></div><div class="half_rhythm"><a href="/books/about/copyright/">Copyright</a> © NICE 2021.</div><div class="small"><span class="label">Bookshelf ID: NBK573053</span><span class="label">PMID: <a href="https://pubmed.ncbi.nlm.nih.gov/34424625" title="PubMed record of this title" ref="pagearea=meta&targetsite=entrez&targetcat=link&targettype=pubmed">34424625</a></span></div></div><div class="small-screen-prev"></div><div class="small-screen-next"></div></article><article data-type="table-wrap" id="figobniceng198er9tab1"><div id="niceng198er9.tab1" class="table"><h3><span class="label">Table 1</span><span class="title">Summary of the protocol</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK573053/table/niceng198er9.tab1/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng198er9.tab1_lrgtbl__"><table><tbody><tr><th id="hd_b_niceng198er9.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><td headers="hd_b_niceng198er9.tab1_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">People with acne vulgaris and polycystic ovarian syndrome, of all ages and levels of acne severity</td></tr><tr><th id="hd_b_niceng198er9.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><td headers="hd_b_niceng198er9.tab1_1_1_2_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Topical treatments including abrasive/cleaning agents, anthelmintics, antibacterials, antibiotics, antiseptics, dicarboxylic acids, vitamin B3, retinoids or retinoid-like agents, or any combination of these.</div></li><li class="half_rhythm"><div>Oral antibiotics including, for example, carbapenems, cephamycins/cephalosporins, sulphones, fucidic acid, lincosamides, macrolides, monobactams, penicillins, or any combination of these.</div></li><li class="half_rhythm"><div>Oral isotretinoin.</div></li><li class="half_rhythm"><div>Hormonal treatments including (monophasic and phasic) progestogen-only contraceptives, co-cyprindiol, and combined oral contraceptives.</div></li><li class="half_rhythm"><div>Hormone-modifying agents including, for example, aldosterone antagonists (for example, spironolactone), class 5α-reductase inhibitor (for example, dutasteride), other non-steroidal anti-androgens (for example, flutamide), and metformin.</div></li><li class="half_rhythm"><div>Physical treatments including chemical peels (for example, salicylic acid), comedone extraction, and treatments using energy-based devices (for example, photochemical therapy, photodynamic therapy, photopneumatic therapy, photothermal therapy, radiofrequency therapy).</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng198er9.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison</th><td headers="hd_b_niceng198er9.tab1_1_1_3_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Any other active intervention</div></li><li class="half_rhythm"><div>No treatment</div></li><li class="half_rhythm"><div>Placebo</div></li><li class="half_rhythm"><div>Sham physical treatment</div></li><li class="half_rhythm"><div>Waiting list</div></li></ul>
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</td></tr><tr><th id="hd_b_niceng198er9.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcome</th><td headers="hd_b_niceng198er9.tab1_1_1_4_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;"><b>Critical</b><ul><li class="half_rhythm"><div>Clinician-rated improvement at treatment endpoint
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<ul class="circle"><li class="half_rhythm"><div>Percentage change in acne lesion count</div></li><li class="half_rhythm"><div>Change or final score on a validated acne severity scale</div></li></ul></div></li><li class="half_rhythm"><div>Prevention of scarring at any follow-up
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<ul class="circle"><li class="half_rhythm"><div>Change from baseline or final number of scars</div></li><li class="half_rhythm"><div>Incidence of scarring</div></li></ul></div></li><li class="half_rhythm"><div>Participant rated improvement
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<ul class="circle"><li class="half_rhythm"><div>Change in acne severity or symptoms (e.g. assessed using global acne score)</div></li></ul></div></li></ul><b>Important</b><ul><li class="half_rhythm"><div>Acceptability
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<ul class="circle"><li class="half_rhythm"><div>Treatment discontinuation for any reason.</div></li></ul></div></li><li class="half_rhythm"><div>Tolerability
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<ul class="circle"><li class="half_rhythm"><div>Treatment discontinuation due to side effects.</div></li></ul></div></li><li class="half_rhythm"><div>Relapse
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<ul class="circle"><li class="half_rhythm"><div>Relapse after treatment at follow-up.</div></li></ul></div></li><li class="half_rhythm"><div>Side effects</div></li></ul>
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Specific short-term side effects for comparisons of treatments within the same class or those that involve an inactive arm (for example, placebo, no or sham treatment).</td></tr></tbody></table></div></div></article><article data-type="table-wrap" id="figobniceng198er9tab2"><div id="niceng198er9.tab2" class="table"><h3><span class="label">Table 2</span><span class="title">Summary of included studies</span></h3><p class="large-table-link" style="display:none"><span class="right"><a href="/books/NBK573053/table/niceng198er9.tab2/?report=objectonly" target="object">View in own window</a></span></p><div class="large_tbl" id="__niceng198er9.tab2_lrgtbl__"><table class="no_bottom_margin"><thead><tr><th id="hd_h_niceng198er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Study</th><th id="hd_h_niceng198er9.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Population</th><th id="hd_h_niceng198er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Intervention</th><th id="hd_h_niceng198er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Comparison</th><th id="hd_h_niceng198er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Outcomes</th></tr></thead><tbody><tr><td headers="hd_h_niceng198er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<a class="bibr" href="#niceng198er9.s1.1.ref1" rid="niceng198er9.s1.1.ref1">Colonna 2012</a>
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</p>
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<p>RCT</p>
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<p>Italy</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>N=59</p>
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<p>Mean age: 25.5 years</p>
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<p>Baseline acne score on Pillsbury Scale:</p>
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<p>Group A: 2.77±0.53</p>
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<p>Group B: 2.70±0.55</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Group A Ethinylestradiol 30 microgram + drospirenone 3mg</td><td headers="hd_h_niceng198er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Group B Ethinyestradiol 30 microgram + chlormadinone acetate 2mg</td><td headers="hd_h_niceng198er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Clinician-rated improvement at treatment endpoint (6 months, measured by Pillsbury Acne Scale)</div></li></ul>
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</td></tr><tr><td headers="hd_h_niceng198er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<a class="bibr" href="#niceng198er9.s1.1.ref2" rid="niceng198er9.s1.1.ref2">Hagag 2014</a>
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</p>
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<p>RCT</p>
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<p>Israel</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>N=175</p>
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<p>Overall age-(mean (±SD)): 21.6 ±0.7 years</p>
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<p>Baseline acne score on Leeds Acne Scale:</p>
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<p>Group A: 2.8±0.15</p>
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<p>Group B: 3.2±1.44</p>
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<p>Group C: 3.1±0.75</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>Group A Norgestimate 250 microgram + ethinylestradiol 35 microgram + spironolactone 100mg</p>
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<p>Group B Cyproterone acetate 2mg + ethinylestradiol 35microgram</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Group C Norgestimate 250microgram + ethinylestradiol 35microgram</td><td headers="hd_h_niceng198er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Clinician-rated improvement at treatment endpoint (12 months, measured by Leeds Acne Scale)</div></li><li class="half_rhythm"><div>Participant rated improvement</div></li></ul>
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</td></tr><tr><td headers="hd_h_niceng198er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<a class="bibr" href="#niceng198er9.s1.1.ref3" rid="niceng198er9.s1.1.ref3">Leelaphiwat 2015</a>
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</p>
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<p>RCT</p>
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<p>Thailand</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>N=36</p>
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<p>Mean (±SD) age: 26.72±6.01</p>
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<p>Baseline acne score on Global Acne Grading System:</p>
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<p>Group A: 14.12±5.82</p>
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<p>Group B: 13.31±6.19</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Group A Ethinylestradiol 30microgram + desogestrel 150microgram + spironolactone 25mg</td><td headers="hd_h_niceng198er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Group B Ethinylestradiol 35microgram + cyproterone acetate 2 mg</td><td headers="hd_h_niceng198er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Clinician-rated improvement at treatment endpoint (3 months, Global Acne Grading Scale)</div></li></ul>
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</td></tr><tr><td headers="hd_h_niceng198er9.tab2_1_1_1_1" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>
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<a class="bibr" href="#niceng198er9.s1.1.ref4" rid="niceng198er9.s1.1.ref4">Podfigurna 2020</a>
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</p>
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<p>RCT</p>
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<p>Poland</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_2" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<p>N=120</p>
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<p>Mean (±SD) age: 26.92±4.72 years</p>
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<p>Baseline acne score (on scale from 0–3):</p>
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<p>Group A: 2.32±0.89</p>
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<p>Group B: 2.32±0.89</p>
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</td><td headers="hd_h_niceng198er9.tab2_1_1_1_3" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Group A Ethinylestradiol 30 microgram + drospirenone 3mg</td><td headers="hd_h_niceng198er9.tab2_1_1_1_4" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">Group B Ethinylestradiol 30 microgram + chlormadinone acetate 2mg</td><td headers="hd_h_niceng198er9.tab2_1_1_1_5" rowspan="1" colspan="1" style="text-align:left;vertical-align:top;">
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<ul><li class="half_rhythm"><div>Clinician-rated improvement at treatment endpoint (6 months, measured by 0–3 scale)</div></li></ul>
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</td></tr></tbody></table></div><div class="tblwrap-foot"><div><dl class="temp-labeled-list small"><dl class="bkr_refwrap"><dt></dt><dd><div><p class="no_margin">RCT: randomised controlled trial; SD: standard deviation.</p></div></dd></dl></dl></div></div></div></article></div><div id="jr-scripts"><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/libs.min.js"> </script><script src="/corehtml/pmc/jatsreader/ptpmc_3.22/js/jr.min.js"> </script></div></div>
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