**2. Guidances for effective management of psoriasis**

Although there is no cure for psoriasis, several available therapies can help control skin lesions and associated symptoms. Some treatments can also induce remission for months or longer. Despite availability of numerous topical and systemic treatment options, there is a lack of patient satisfaction with the available treatments and high rates of non-compliance. In order to optimize topical treatment of psoriasis, guidelines have been developed for more effective management of psoriasis. Some of the available guidances for topical treatment are discussed in this section:

The American Academy of Dermatology (AAD) has published a six part series of guidelines in 2009, on the management of psoriasis and psoriatic arthritis. The third section of this series discusses the use of topical medications for the treatment of psoriasis (Menter et al., 2009). This guidance discusses the efficacy and safety of as well as offer recommendations for the use of topical corticosteroids such as vitamin D analogues, tazarotene, tacrolimus, pimecrolimus, emollients, salicylic acid, anthralin, coal tar, as well as combination therapy. The authors concluded that patients with localized psoriasis can be treated with topical agents, which generally provide a high efficacy-to-safety ratio. Topical agents may also be used adjunctively in patients with more extensive psoriasis who are undergoing therapy with either ultraviolet light, systemic or biologic medications. However, the use of topical agents as monotherapy in the generalized form of the disease or in the setting of limited, but recalcitrant, disease was not recommended.

The Cochrane Skin Group in UK published a review of topical therapies for chronic plaque psoriasis following examination of 131 studies (Mason et al., 2009). They concluded that vitamin D analogues showed similar efficacy as potent or very potent corticosteroids when used on the body, whereas topical corticosteroids proved the most effective treatment for scalp psoriasis. Combination of topical corticosteroids and vitamin D analogues were more effective than either agent as single formulation. Although the overall safety of topical therapies was high, topical corticosteroids were associated with lower incidence of local adverse events than vitamin D analogues. Warren et. al. (Warren et al., 2010) has published a review summarizing the guidances on the use of topical, systemic and biological therapies for the treatment of psoriasis; co-morbidities associated with psoriasis; and complementary therapies for psoriasis. The UK National Health Service provides an annual evidence update on psoriasis and has included new guidelines and systematic reviews on psoriasis published or indexed from November 2008 to October 2009 in the *2009 Annual Evidence Update on Psoriasis* from NHS Evidence – Skin Disorders.

In Germany, Nast et. al. have developed an evidence based guidelines for topical treatment (Nast et al., 2007). The guidelines focus on induction therapy in cases of mild, moderate, and severe plaque-type psoriasis in adults and contain a series of therapeutic recommendations. A similar guideline is also available for systemic treatment of psoriasis (Pathirana et al., 2009).

A guide has also been developed to optimize and harmonize the amount of topical medications to be applied on children (Long et al., 1998). Study conducted in children aged between 6 months to 9 years, showed that the amount of an ointment applied on children was similar to that predicted in accordance with these guidelines (Long et al., 1998).

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patients achieving success after 2-4 weeks of treatment in well controlled clinical trials, but the response rates are similar for all presentations. Small differences in vasoconstrictor potency or cutaneous absorption have been noted among the formulations, but the clinical

The development of a foam formulation of clobetasol propionate 0.05% (e.g. Olux®) provides an effective and cosmetically appealing treatment option for patients with plaquetype psoriasis because it spreads easily and is cosmetically elegant. Olux is based on VersaFoam® platform, a thermolabile and low-residue foam. A randomised, placebocontrolled, double-blinded study of 279 patients aged 18 years or older with mild-tomoderate plaque-type psoriasis demonstrated the efficacy and tolerability of clobetasol propionate foam (Gottlied et al., 2003). After 2 weeks of twice-daily applications of clobetasol propionate foam versus vehicle foam, 68% of patients in the active treatment arm were clear of lesions versus 21% of patients receiving placebo. The treatment was well tolerated with 5% of patients receiving clobetasol propionate foam and 7% of those receiving placebo reported burning at the site of application. Although the efficacy of the clobetasol propionate foam can partially be attributed to patient adherence, the foam also delivers the active drug more efficiently than other formulations that have been compared. This may be due to the easier spread of foam onto the skin. In *in vitro* skin penetration studies, application of foam to donor skin resulted in higher drug accumulation and increased rate

A study comparing two novel formulations containing 0.05% clobetasol propionate, Clobex® spray and Olux® foam clearly highlighted the difference in efficacy from two products containing the same active ingredient (Mraz et al., 2008). In a study of 77 randomized patients aged 18 years or older with moderate to severe plaque psoriasis the products were applied as per the product labeling. At the end of the treatment period (2 weeks for foam and 4 weeks for spray), patients treated with clobetasol propionate spray showed a significantly greater median reduction in affected body surface area compared to the clobetasol propionate foam. Improvements in quality of life were statistically significantly greater at all time points for patients treated with clobetasol propionate spray compared to patients treated with the foam formulation. The majority of adverse events for both products

Clobex® shampoo containing 0.05% clobetasol propionate is a once-daily, short-contact, shampoo treatment for moderate-to-severe scalp psoriasis (Feldman & Yentzer, 2009). The efficacy and safety of clobetasol propionate 0.05% shampoo was evaluated in a randomized, double-blind, vehicle-controlled clinical trial of 142 patients aged 12 years and older with moderate-to-severe scalp psoriasis (Jarratt et al., 2004). Patients applied clobetasol propionate shampoo or vehicle shampoo once daily for 15 minutes for four weeks. Treatment success (defined as a global psoriasis rating of "clear" or "minimal") was obtained for 42% of patients who used clobetasol propionate shampoo versus 2% of patients who used vehicle shampoo. Recurrence of the scalp psoriasis, assessed during a two week follow-up period, showed that the clobetasol propionate shampoo was more effective than the vehicle shampoo in preventing recurrence after treatment was discontinued. Similar safety profile was established between the clobetasol propionate shampoo and vehicle shampoo. No skin atrophy, telangiectasia, acne or severe adverse events were noted for

significance of these observations is difficult to discern.

of permeation into skin layers (Huang et al., 2005).

were mild in severity (Mraz et al., 2008).

either treatment group (Jarratt et al., 2004).
