International Journal of Scientific & Engineering Research Volume 9, Issue 8, August ISSN

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1 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August Safety and efficiency of a topical corticosteroid in psoriasis Bahni Mohammed Ali Asiri Abstract: The aim of this study was to perform a literature review to prepare for evidence-based recommendations on the efficacy of topical corticosteroids in psoriasis including treatment modalities to induce remission and prevent recurrence. We conducted an electronic search through online databases such; Medline, and Embase, for studies concerning efficacy of topical corticosteroids in psoriasis. Topical CS are an essential component of the psoriasis therapeutic apparatus. The outcomes of this existing review indicate that topical steroids in the therapy of adult psoriasis are extremely safe if utilized according to the guidelines. The indication of topical steroids for psoriasis should be limited to mild or moderate psoriasis with much less compared to 10% of body surface location impacted making use of a 4-week daily therapy. The effectiveness of treatment should be assessed within 1-2 months after the preliminary prescription. Introduction: Psoriasis is a chronic inflammatory disease affecting 1-2% of the populace around the world [1].Medically, psoriasis presents as well-demarcated, increased, erythematous, scaly plaques predominantly impacting the scalp, trunk and extensor surface areas; nevertheless, anybody site can additionally be entailed. Psoriasis is an emotionally incapacitating condition and can have

2 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August extensive effect on patients' top quality of life despite the degree of body surface area (BSA) participation. Mild-to-moderate psoriasis impacts ~ 80% of the overall psoriasis population around the world [2]. Topical medicine is typically made use of as very first line of treatment in moderate psoriasis yet could also be used with phototherapy, systemic or biologic treatments for moderate-to-severe psoriasis. Topical steroids are used for more compared to 50 years for the treatment of mild-tomoderate adult plaque psoriasis. Their short-term efficiency differs from 5% to 90% relying on molecule and solution [3].Systemic results complying with application of topical steroids belong to systemic absorption of the product. Exogenous glucocorticoids have a suppressive impact on hypothalamic corticotropin-releasing hormone and pituitary adrenocorticotropic hormone (ACTH). With extended use corticosteroids, reductions of the hypothalamic-pituitary axis (HPA) and adrenal insufficiency by adrenal glands degeneration could take place, and it could take months to recoup fully after discontinuation of exogenous glucocorticoids.the boosted degree of glucocorticoids in the blood can additionally cause professional signs of hypercorticism (iatrogenic Cushing disorder) such as arterial hypertension, diabetes, anxiety or irritation, faciotroncular obesity, buffalo neck, hirsutism, vulnerable skin, pink striae and telangiectasia. Systemic absorption of topical steroids differs according to age, skin lesions place and extension of the illness. Furthermore, duration of use, strength, formulation and molecule used could additionally contribute [4].In addition, the function of particular skin conditions requires to be taken into consideration in the capacity for topically applied steroids to produce negative effects. Without a doubt, conditions connected with skin obstacle damages such as atopic dermatitis or Netherton condition have been related to enhanced percutaneous absorption of topical corticosteroids and HPA axis reductions. This remains unclear in the situation of plaque psoriasis

3 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August which is to be taken into consideration as a chronic skin disease needing lasting treatment in a lot of patients and in some cases huge amount of topical steroids. Skin degeneration is the most problematic local side result which making complex the long term use topical steroids. It is clinically defined by thinning of the skin, loss of elasticity, loss of skin noting, telangiectasia and purpura. The aim of this study was to perform a literature review to prepare for evidence-based recommendations on the efficacy of topical corticosteroids in psoriasis including treatment modalities to induce remission and prevent recurrence. Methodology: We conducted an electronic search through online databases such; Medline, and Embase, for studies concerning efficacy of topical corticosteroids in psoriasis, using the keywords psoriasis AND corticosteroid. search included all studies published in English language up to 2018, May. and we limited our search to only Human subject articls. Discussion: Psoariasis Psoriasis is an immune-mediated chronic inflammatory disease in which inflammation and cell proliferation could happen over. The immunopathogenesis inclusives a wide variety of signaling actions that can be targeted in order to apply a details restorative impact [5,6].The kinase/ STAT pathway( signal transducers and activators of transcription) and PDE4 (phosphodiesterase-4) include intracellular signal transduction necessary for inflammation to create [7-10].Pan-selectin villains inhibit leukocyte extravasation by influencing the capability of immune cells to roll and migrate, consequently reducing inflammation [11,12].Lastly, the system of action of nonsteroidal

4 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August anti-inflammatory representatives stated in this article are as yet not completely recognized but have been revealed to lower cytokine production and cellular proliferation - the two significant elements of psoriasis immunopathogenesis. Efficacy of topical corticosteroid treatment Topical CS are available in a variety of vehicles and can be identified in order of lowering potency, with 7 courses in the USA and four in the UK, as per Stoughton-Cornell classification (Table 1) [13,14].Various other countries might utilize different classifications systems. These classification systems take into consideration the therapeutic index, a ratio comparing the amount of the agent that causes the therapeutic result to the quantity of the agent that triggers harmful impacts. CS of reduced effectiveness are mainly used on the face, groin, axillary areas, and in infants and youngsters, whereas mid- and higher-potency CS are generally utilized as initial treatment on all other locations in grownups. Superpotent CS are mainly utilized for persistent, cutaneous plaques or lesions on the scalp, hands, and/or soles. When used with care, topical CS could be effective and secure. Daily usage in the induction phase of treatment could cause rapid improvement within 4 weeks in up to 46-56% for potent (e.g. betamethasone dipropionate), and up to 68-89% for superpotent (e.g. clobetasol-17-propionate) CS [15,16].For those patients with less resistant plaque psoriasis, therapy may be initiated with lower strength agents if feasible. For more resistant lesions, standards generally recommend that greatest strength agents be restricted for approximately a maximum of 2 weeks of everyday usage [14,17].The German evidencebased guideline suggests selecting and readjusting the class of CS based on the particular skin site to be treated [15,16].There might be distinctions in efficacy and patient adherence with various prep work of CS. To assist patients dosage their topical therapies, the fingertip system concept or application devices could be utilized [18].In medical technique, potent and superpotent CS are

5 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August usually utilized as preliminary treatment to attain quick resolution of lesions. In patients with extensive psoriasis and/or those whose psoriasis substantially affects their quality of life, topical treatment alone may not suffice, and therapy with phototherapy or systemic therapy, including biologics, must be taken into consideration. Table 1. Corticosteroid classification system[13],[14]. Superpotent Class I USA; Class I UK; Class IV Germany Betamethasone dipropionate glycol 0.05% Clobetasol 17-propionate 0.05% Halobetasol propionate 0.05% High potency Class II/III USA; Class II UK; Class III Germany Amcinonide 0.1% Betamethasone dipropionate 0.05% Desoximetasone 0.25% Diflucortolone valerate 0.1% Fluocinonide 0.05% Halcinonide 0.1% Mometasone furoate 0.1% Ointment Cream Lotion Triamcinolone acetonide 0.5% Moderate potency Class IV/V USA; Class III UK; Class II Germany Betamethasone dipropionate 0.05% Betamethasone valerate 0.1% Clobetasone 17-butyrate 0.05% Desonide 0.05% Desoximetasone 0.05% Fluocinonide 0.025% Hydrocortisone 17-valerate 0.2% Prednicarbate 0.1% Triamcinolone acetonide 0.1% Low potency Class VI/VII USA; Class IV UK; Class I Germany Betamethasone valerate 0.05% Desonide 0.05% Fluocinonide 0.01% Hydrocortisone 1.0%, 2.5% Hydrocortisone acetate 0.5%, 1.0% Prednicarbate 0.05% Triamcinolone acetonide 0.025% Efficacy of topical steroids in the treatment of scalp psoriasis: (Fig. 1)

6 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August Eighteen tests focused on the use of topical steroids for scalp psoriasis [19-22],[23-36].Sixteen were between-patient [19-22],[23-31],[33-35] and 2 were within-patient researches [36],[32].Therapy duration varied from 2 to 8 weeks with the majority of durations being less compared to 6 weeks [37],[19-22],[24-28],[31-34],[36].The number of enlisted patients varied from 42 to 1417 patients inning accordance with the test (mean 395 patients). Standards for success went to the very least 75% enhancement in first psoriasis seriousness in seven trials [19],[20],[22],[24],[25],[28],[34] and at the very least 90% (clear or nearly clear) in seven tests [21], [23], [26], [29], [31], [35],[36].In 4 researches [37],[27],[32],[32],[33] efficiency can not be examined according to the definition of therapy success. An overall of 40-75% patients across studies experienced greater than 75% of preliminary scalp psoriasis renovation and from 43% to 90% experienced greater than 90% first psoriasis improvement as shown in Fig. 1. Figure 1. Efficacy of topical steroids in the treatment of scalp psoriasis [19-22],[23-36]. * The response was defined by the investigators as following: a clear or marked improvement b at least 75% improvement c clear or almost clear d absence of disease or very mild disease

7 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August Abbreviations: CP: clobetasol, BMD: betamethasone dipropionate, DMT: desoximethasone, FLUO: fluocinonide, MO: mometasone, N: number of patients in the topical steroid arm, BMV: betamethasone valerate, AMC: amcinonide; TS: topical steroid assessed Efficacy of topical corticosteroids and frequency of application Senter et al. [39] contrasted once-a-day application utilizing fluocinonide vs. a four-times-a-day application routine for 6 weeks in 55 psoriasis patients. A mean amount of 429 g of fluocinonide was utilized per patient in the four times everyday application group contrasted with 132 g in the when everyday application group. There was no significant difference in between the 2 groups in regards to efficacy. Efficiency of topical steroids as a maintenance treatment for body plaque psoriasis Three studies evaluated the maintenance treatment of body plaque psoriasis with only two providing with maintenance efficiency information[39-41].katz et al. [40] performed an open label screening stage with increased bethametasone dipropionate (ABD) twice daily for 3 or 4 weeks. In responders, 46 patients received ultimately 3 successive applications of ABD 12 h a component, once a week, for 5 months and 44 patients obtained vehicle with the very same routine. At 6 months, 65% of patients treated with ABD stayed in remission vs. 20% of vehicle patients. Lebwhol et al. [41] treated 44 patients with a 2-week run in period with everyday calcipotriene lotion in the morning and halobetasol lotion. Patients who were at least moderately (50% or higher) improved were randomized to get halobetasol ointment two times daily on week-end and calcipotriene ointment two times daily on weekdays (20 patients), or to get halobetasol ointment two times daily on week-end and placebo ointment twice everyday on weekdays (20 patients). Forty percent (n =8) of patients using halobetasol lotion on week-end just with the car on

8 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August weekdays were able to preserve remission for 6 months contrasted with 76% (n =13) of patients using halobetasol ointment on week-end and calcipotriene ointment on weekdays recommending that the enhancement of calcipotriene ointment applied on weekdays to a week-end pulse treatment program of superpotent corticosteroid can enhance the duration of psoriasis remission. Topical steroids as a maintenance treatment for scalp psoriasis The only research study assessing the benefit of a maintenance therapy for scalp psoriasis was released by Poulin et alia [42].In the trial, 212 individuals with moderate-to-severe scalp psoriasis were at first handled with CP( clobetasol propionate) hair shampoo once a day for as much as 4 weeks. Responders were consequently randomized to obtain the CP hair shampoo or vehicle twice weekly on a maintenance program for as much as 6 months. When a regression happened defined as GSS > 2, individuals returned to day-to-day CP shampoo therapy. When the symptoms lessened (GSS < or = 2), they went back to the twice-weekly upkeep routine. After 6 months 31.1% (33 106) of participants in the CP shampoo team were still relapse complimentary, vs. 8.1% (9 111) of participants in the car group (P < 0.01). Safety of topical corticosteroid treatment Topical CS can be related to many prospective unfortunate impacts consisting of cutaneous degeneration, development of telangiectasia, growth of striae, steroid rosacea and perioral dermatitis, hypothalamic-pituitary-adrenal (HPA) axis suppression, skin infections and various other effects. Striae are permanent and difficult to deal with, while telangiectasia and atrophy could be lasting or permanent. The possibility for negative effects is usually linked with extended and/or extensive use of topical CS and typically associates with increased medical strength. The face and the intertriginous locations are particularly conscious these results. Systemic absorption

9 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August of CS could result in laboratory evidence of adrenal reductions, and danger aspects consist of high potency CS, occlusive or long term therapy duration and use in thin-skinned locations.9 Children are extra at risk to these systemic negative effects, because of their smaller body mass in relationship to the surface area included; nonetheless, non-reversible additional adrenal insufficiency has not been recorded [43].Security of topical CS and various other topical treatments has been just recently evaluated [44]. Although topical CS have the possible to cause skin atrophy and short-lived adrenal reductions, it is less clear to just what degree such negative effects happen when topical CS are used in the management of psoriasis. There is generally no medical proof of skin atrophy and limited instances of reversible adrenal reductions when used for brief durations of time [45-50].The risk of skin degeneration raises when CS are used on thin skin such as the face and the intertriginous areas, yet reduced potency CS generally pose much less of an iatrogenic danger. In one research study, no impacts on skin thickness were observed in 30 patients with psoriasis or other forms of facial dermatoses treated with clobetasone butyrate 0.05% ointment for approximately 7 weeks [51].In an additional research study of 20 grownups treated with fluticasone propionate 0.005% ointment twice daily for 2 weeks, after that when day-to-day for two successive days every week for 8 weeks, skin atrophy and telangiectasia did not take place [52]. Cutaneous atrophy was additionally not observed when mometasone furoate 0.1% ointment was used daily to the face and intertriginous areas of 15 psoriasis patients for 2 weeks [53].Extra studies with more patients complied with over much longer amount of times are had to much better understand the effects of these representatives on skin atrophy. Psoriasis is a chronic condition and requires a protracted therapeutic approach, making it challenging to use high-potency topical CS safely in lasting management of the condition.

10 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August Adverse effects of topical CS have been well-documented, and some basic principles should be followed to minimize these impacts (Table 2). The proof for possible therapy regimens exists listed below; nonetheless, some of these usages may be off-label. Table 2.Strategies to improve safety for long-term use of topical corticosteroids. 1.Use treatment regimens that minimize side effects (e.g. weekend only/pulse therapy) 2.Combine topical corticosteroids with other topical agents 3.Follow package insert recommendations 4.Use caution in vulnerable areas (i.e. face, intertriginous or other thin-skinned areas) 5.Use caution in infants and children Conclusion: Topical CS are an essential component of the psoriasis therapeutic apparatus. The outcomes of this existing review indicate that topical steroids in the therapy of adult psoriasis are extremely safe if utilized according to the guidelines. The indication of topical steroids for psoriasis should be limited to mild or moderate psoriasis with much less compared to 10% of body surface location impacted making use of a 4-week daily therapy. The effectiveness of treatment should be assessed within months after the preliminary prescription. While relatively risk-free in the temporary, approaches such as the weekend-only/pulse therapy program or incorporating topical CS with other topical agents may enhance their security profile over longer periods. Caution has to be used when topical CS are applied in vulnerable locations and in infants and youngsters. Extra long-lasting studies of topical corticosteroids are required, ways to detect early damages ought to be checked out, and new topical agents with improved restorative indices should be developed. This examination is vital to prevent misusage and subsequently issues from utilizing topical steroids. Reference:

11 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009;361: Menter A, Gottlieb A, Feldman SR, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis: section 1. Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol 2008;58: Castela E, Archier E, Devaux S, et al. Topical corticosteroids in plaquepsoriasis: a systematic review of efficacy and treatment modalities. J Eur Acad Dermatol Venereol 2012; 26 (Suppl. 3): Bucks DA, Maibach HI, Guy RH. Percutaneous absorption of steroids: effect of repeated application. J Pharm Sci 1985; 74: Nograles KE, Davidovici B, Krueger JG. New insights in the immunologic basis of psoriasis. Semin Cutan Med Surg 2010;29: Johnson-Huang LM, McNutt NS, Krueger JG, Lowes MA. Cytokine-producing dendritic cells in the pathogenesis of inflammatory skin diseases. J Clin Immunol 2009;29: Murray PJ. The JAK-STAT signaling pathway: input and output integration. J Immunol 2007;178: Dastidar SG, Rajagopal D, Ray A. Therapeutic benefit of PDE4 inhibitors in inflammatory diseases. Curr Opin Investig Drugs 2007;8: Sano S, Chan KS, DiGiovanni J. Impact of Stat3 activation upon skin biology: a dichotomy of its role between homeostasis and diseases. J Dermatol Sci 2008;50: Baumer W, Hoppmann J, Rundfeldt C, Kietzmann M. Highly selective phosphodiesterase 4 inhibitors for the treatment of allergic skin diseases and psoriasis. Inflamm Allergy Drug Targets 2007;6: Song H, Wang R, Wang S, Lin J. A low-molecular-weight compound discovered through virtual database screening inhibits Stat3 function in breast cancer cells. Proc Natl Acad Sci USA 2005;102: Miyoshi K, Takaishi M, Nakajima K, et al. Stat3 as a therapeutic target for the treatment of psoriasis: a clinical feasibility study with STA-21, a Stat3 inhibitor. J Invest Dermatol 2011;131: Lebwohl M, Ting PT, Koo JY. Psoriasis treatment: traditional therapy. Ann Rheum Dis 2005; 64(Suppl.): ii Menter A, Griffiths CE. Current and future management of psoriasis. Lancet 2007; 370: Nast A, Kopp IB, Augustin M et al. Evidence-based (S3) guidelines for the treatment of psoriasis vulgaris. J Dtsch Dermatol Ges 2007; 5(Suppl.): Nast A, Kopp I, Augustin M et al. German evidence-based guidelines for the treatment of psoriasis vulgaris (short version). Arch Dermatol Res 2007; 299: Del Rosso J, Friedlander SF. Corticosteroids: options in the era of steroid-sparing therapy. J Am Acad Dermatol 2005; 53: S50 S Bewley A. Expert consensus: time for a change in the way we advise our patients to use topical corticosteroids. Br J Dermatol 2008; 158:

12 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August Olsen EA, Cram DL, Ellis CN et al. A double-blind, vehicle-controlled study of clobetasol propionate 0.05% (Temovate) scalp application in the treatment of moderate to severe scalp psoriasis. J Am Acad Dermatol 1991; 24: Ellis CN, Horwitz SN, Menter A. Amcinonide lotion 0.1% in the treatment of patients with psoriasis of the scalp. Curr Therapeu Res Clin Exp 1988; 44: Franz TJ, Parsell DA, Halualani RM et al. Betamethasone valerate foam 0.12%: a novel vehicle with enhanced delivery and efficacy. Int J Dermatol 1999; 38: Katz HI, Lindholm JS, Weiss JS et al. Efficacy and safety of twice-daily augmented betamethasone dipropionate lotion versus clobetasol propionate solution in patients with moderate-to-severe scalp psoriasis. Clin Ther 1995; 17: Van de Kerkhof PCM, Hoffmann V, Anstey A et al. A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial. Br J Dermatol 2009; 160: Willis I, Cornell RC, Penneys NS et al. Multicenter study comparing 0.05% gel formulations of desoximetasone and fluocinonide in patients with scalp psoriasis. Clin Ther 1986; 8: VanderPloeg DE, Cornell RC, Binder R et al. Clinical trial in scalp psoriasis mometasone furoate lotion 0.1% apllied once daily vs betamethasone valerate lotion 0.1% applied twice daily. Acta Therapeutica 1989; 15: Reygagne P, Mrowietz U, Decroix J et al. Clobetasol propionate shampoo 0.05% and calcipotriol solution 0.005%: a randomized comparison of efficacy and safety in subjects with scalp psoriasis. J Dermatolog Treat 2005; 16: Pauporte M, Maibach H, Lowe N et al. Fluocinolone acetonide topical oil for scalp psoriasis. J Dermatolog Treat 2004; 15: Klaber MR, Hutchinson PE, Pedvis-Leftick A et al. Comparative effects of calcipotriol solution (50 micrograms ml) and betamethasone 17-valerate solution (1 mg ml) in the treatment of scalp psoriasis. Br J Dermatol 1994; 131: Jemec GBE, Ganslandt C, Ortonne J et al. A new scalp formulation of calcipotriene plus betamethasone compared with its active ingredients and the vehicle in the treatment of scalp psoriasis: a randomized, double-blind, controlled trial. J Am Acad Dermatol 2008; 59: Jemec GBE, van de Kerkhof PCM, Enevold A et al. Significant one week efficacy of a calcipotriol plus betamethasone dipropionate scalp formulation. J Eur Acad Dermatol Venereol 2011; 25: Jarratt M, Breneman D, Gottlieb AB et al. Clobetasol propionate shampoo 0.05%: a new option to treat patients with moderate to severe scalp psoriasis. J Drugs Dermatol 2004; 3: Jarratt M, Davis JG, Giltner MP, Jones ML, Peets EA. Comparative studies of augmented betamethasone dipropionate lotion 0.05% and clobetasol propionate solution 0.05%:

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14 International Journal of Scientific & Engineering Research Volume 9, Issue 8, August Katz HI, Gross E, Buxman M et al. A double-blind, vehicle-controlled paired comparison of halobetasol propionate cream on patients with plaque psoriasis.j Am Acad Dermatol 1991; 25: Andres P, Poncet M, Farzaneh S et al. Short-term safety assessment of clobetasol propionate 0.05% shampoo: hypothalamic-pituitary-adrenal axis suppression, atrophogenicity, and ocular safety in subjects with scalp psoriasis. J Drugs Dermatol 2006; 5: Beutner K, Chakrabarty A, Lemke S et al. An intra-individual randomized safety and efficacy comparison of clobetasol propionate 0.05% spray and its vehicle in the treatment of plaque psoriasis. J Drugs Dermatol 2006; 5: Ishi M, Kohno T, Kitajima JI. Clinical evaluations of clobetasone 17- butyrate ointment on the various facial dermatoses. Skin Res 1986; 28: Lebwohl MG, Tan MH, Meador SL et al. Limited application of fluticasone propionate ointment, 0.005% in patients with psoriasis of the face and intertriginous areas. J Am Acad Dermatol 2001; 44: LebwohlM, Peets E, Chen V. Limited application of mometasone furoate on theface and intertriginous areas: analysis of safety and efficacy.int J Dermatol 1993; 32: