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Topical Benzoyl Peroxide for Acne (Protocol) Topical benzoyl peroxide for acne (Protocol) Yang Z, Zhang Y, Lazic Mosler E, Li H, Hu J, Zhang Y, Liu J, Zhang Q This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2014, Issue 6 http://www.thecochranelibrary.com Topical benzoyl peroxide for acne (Protocol) Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 BACKGROUND .................................... 1 OBJECTIVES ..................................... 3 METHODS ...................................... 3 ACKNOWLEDGEMENTS . 6 REFERENCES ..................................... 7 ADDITIONALTABLES. 9 APPENDICES ..................................... 12 CONTRIBUTIONSOFAUTHORS . 16 DECLARATIONSOFINTEREST . 16 SOURCESOFSUPPORT . 17 Topical benzoyl peroxide for acne (Protocol) i Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. [Intervention Protocol] Topical benzoyl peroxide for acne Zhirong Yang1,2, Yuan Zhang3, Elvira Lazic Mosler4, Hang Li5, Jing Hu1, Yanchang Zhang6, Jia Liu7, Qian Zhang8 1Centre for Evidence Based Medicine and Clinical Research, Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing, China. 2Shantou-Oxford Clinical Research Unit, Shantou University Medical College, Shantou, Guang- dong, China. 3Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Canada. 4Department for Dermatology and Venereology, General Hospital “Dr. Ivo Pediši ”, Sisak, Croatia. 5Dermatologic Department, Peking University First Hospital, Beijing, China. 6Department of Chronic Disease Epidemiology, Yale School of Public Health, New Haven, Connecticut, USA. 7Department of Geriatric Neurology, Chinese PLA General Hospital, Beijing, China. 8c/o Cochrane Skin Group, The University of Nottingham, Nottingham, UK Contact address: Zhirong Yang, [email protected]. Editorial group: Cochrane Skin Group. Publication status and date: New, published in Issue 6, 2014. Citation: Yang Z, Zhang Y, Lazic Mosler E, Li H, Hu J, Zhang Y, Liu J, Zhang Q. Topical benzoyl peroxide for acne. Cochrane Database of Systematic Reviews 2014, Issue 6. Art. No.: CD011154. DOI: 10.1002/14651858.CD011154. Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. ABSTRACT This is the protocol for a review and there is no abstract. The objectives are as follows: To assess the effects of benzoyl peroxide for acne. BACKGROUND to severe acne constitutes 15% to 20% of all cases (Bhate 2013; Dréno 2010; Law 2010; Wei 2010). Girls are likely to suffer from acne earlier than boys (Archer 2012), but boys appear to be more Description of the condition susceptible to the disease (Halvorsen 2011). Acne may decrease with age, but 64% of people aged 20 to 29 years and 43% of Acne vulgaris is a common, chronic inflammatory disease of pi- people aged 30 to 39 years may still have visible acne (Bhate 2013; losebaceous units. It is characterised by increased sebum produc- Schäfer 2001). Globally, acne is the second most disabling skin tion and the formation of comedones, erythematous papules, pus- disease after eczema (Murray 2012). tules and nodules, which may lead to scarring (Archer 2012). For an explanation of the terminology used throughout the text, please refer to the glossary in Table 1. Pathogenesis Multiple factors are involved in the development of acne. An in- Epidemiology creased level of androgens at puberty, greater sebum production Acne vulgaris affects nearly all adolescents and adults at some time and abnormal hyperproliferation of keratinocytes leads to the de- in their lives (Webster 2002). It is estimated that up to 40 to 50 velopment of small microscopic lesions called microcomedones. In million individuals in the USA have acne, with an 85% prevalence this lipid-rich and anaerobic environment Propionibacterium acnes in those aged 12 to 24 years (Bhate 2013; White 1998). Moderate (P. acnes), which is present in normal follicles, proliferates abnor- Topical benzoyl peroxide for acne (Protocol) 1 Copyright © 2014 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. mally. Conventionally, it is believed that abnormal colonisation be action primarily against comedones (retinoids and salicylic acid) of P. acnes initiates the production of inflammatory and chemo- or against inflammatory lesions (antibacterials and antibiotics). tactic mediators, which drives the inflammatory processes (Brown Benzoyl peroxide is an oxidising agent that is bactericidal for 1998; Burkhart 1999; Cunliffe 2000; Gollnick 2003). There is P. acnes. Besides its primary bactericidal effect on P. acnes, it also evidence suggesting the involvement of inflammation at all also has mild anti-inflammatory, as well as comedolytic activity the stages of acne development (Jeremy 2003; Tanghetti 2013), (Patel 2010; Strauss 2007). Treatment of acne vulgaris with ben- and the exact sequence of events and the interaction between these zoyl peroxide alone or in combination with other topical treat- events and other possible factors (genes, diet, smoking, sunlight, ments (antibiotics, retinoid, salicylic acid or zinc) at concentra- etc.) remains unclear (Williams 2012). tions of 2% to 5% is the standard of care for mild to moderate acne (Bojar 1994; Dutil 2010; Gollnick 2003; Lookingbill 1997; Strauss 2007). The most common fixed-combination products Diagnosis and outcome measures containing benzoyl peroxide are clindamycin with benzoyl per- oxide, erythromycin with benzoyl peroxide and adapalene with Clinical diagnosis of acne is usually straightforward. The condition benzoyl peroxide (Layton 2009; Taylor 2004). Besides benzoyl tends to affect the face (99%), the back (60%) and the chest (15%) peroxide, other potentially efficient over-the-counter agents for (Archer 2012), where the lesions are comedones (whiteheads and acne treatment include azelaic acid, alpha-hydroxy acids, resor- blackheads), which are non-inflamed lesions (Simpson 2008). In- cinol, sulphur and zinc, but evidence of their effectiveness from flammatory lesions such as papules, pustules, nodules and cysts randomised controlled clinical trials and studies comparing their may develop after the non-inflamed lesions (Layton 2010). Papules efficacy with other topical treatments is still lacking. and pustules are superficial lesions 5 mm or less in diameter, but There is also an increasingly wide range of non-drug-based ap- they may evolve into deep pustules or nodules in more severe forms proaches that have been developed for treating acne, among of the disease. In conglobate acne, suppurative nodules can extend which low-concentration chemical peels with glycolic, salicylic deeply and over larger areas, forming exudative sinus tracts and or trichloroacetic acid are beneficial for the reduction of come- tissue destruction, resulting in extensive and disfiguring scarring. dones (Kempiak 2008; Rendon 2010). In addition, comedo ex- Classification of acne severity at the time of diagnosis is important tractions, light electrocautery, electrofulguration and cryotherapy because guidelines for subsequent treatment are based on the sever- present other therapeutic options for comedonal acne. In addition, ity of disease (Nast 2012; Strauss 2007; Thiboutot 2009). Acne acne can be treated by photodynamic therapy, utilising topical 5- can be assessed and subsequently classified from two perspectives: aminolevulinic acid together with various light sources (e.g. blue, as objective disease activity based on measurement of the visible red, intense pulsed) or lasers (e.g. pulsed dye, 635 nm red diode), signs of acne by an investigator, or as a patient assessment of the as well as methyl aminolevulinate plus red light. Blue or intense impact on their quality of life (Nast 2012). More than 25 acne pulsed light alone and lasers such as the pulsed dye, the 1320 nm assessment scales have been described and they are inconsistently neodymium:YAG and especially the 1450 nm diode may be of used across different trials (Lehmann 2002). This does not allow therapeutic benefit for inflammatory acne (Rai 2013). For deep, a direct comparison of the results of separate trials (Nast 2012; inflamed nodules and cysts, intralesional injections of corticos- Zarchi 2012). Additionally, grading is a subjective measure that teroids, such as triamcinolone acetate, are beneficial (Levine 1983; may vary from one dermatologist to another (Ramli 2012). In Strauss 2007). clinical trials, assessment of the severity of acne before and after Commercially available over-the-counter preparations of benzoyl the intervention is essential to determine the therapeutic effect peroxide include gels, creams, lotions, soaps and washes, rang- (Zarchi 2012). Grading and lesion counting appear to be most ing from 2.5% to 10% in concentration (Strauss 2007; Zaenglein frequently used for this purpose (Zarchi 2012), as is described in 2006). The choice of vehicle depends largely on skin type and the the revised Leeds acne grading system, which includes numeri- person’s preference (Brown 1998). Irritant dermatitis (erythema, cal grading systems for the back and chest as well as for the face scaling, burning and itching) is the primary limitation of benzoyl (Lehmann 2002). peroxide for some people; this primarily occurs within the first few days of treatment but generally subsides with continued use (Gollnick 2003; Sagransky
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