New Medicines Committee Briefing November 2013 Topical Corticosteroids Topical corticosteroids are to be reviewed for use within: Primary Care Secondary Care Formulary application: Consultant submitting application: Dr Nicholas Craven (Consultant Dermatologist) Clinical Director supporting application: Mr Gareth Rowland Dr Craven has requested that the whole skin section of the formulation be reviewed. As part of this process, the topical corticosteroid section is being reviewed. Dr Craven has requested that fluocinolone acetonide 0.0025% cream, fluocinolone acetonide 0.00625% cream and ointment, fluocinolone acetonide 0.025% cream, gel and ointment, fluocinolone acetonide 0.025% with clioquinol 3% cream and ointment, fluocinolone acetonide 0.025% with neomycin 0.5% cream and ointment, Haelan® tape, Trimovate® cream, Diprosalic® ointment and Nerisone Forte® oily cream and ointment be included in the North Staffordshire Joint Formulary while the following corticosteroids: hydrocortisone 0.5% cream and ointment 30g, hydrocortisone 1% cream and ointment 50g, hydrocortisone 2.5% cream and ointment, Canesten HC® cream 15g, Daktacort® cream 15g, Fucidin H® cream 60g, Betnovate® scalp application, Fucibet® cream 60g, and Clarelux® Foam Scalp Application) be removed from the Joint Formulary. Dr Craven states that Haelan® tape would be used in the following conditions: nodular prurigo, lichen simplex, fissured dermatitis, stubborn plaques of psoriasis, chronic discoid lupus erythematosus and granuloma annulare, plus any other stubborn localised steroid-responsive dermatoses. The super-potent topical steroids such as Dermovate® and Nerisone Forte® are used when the affected areas are more extensive. He also stated that the Synalar® products will be used in patients allergic to hydrocortisone, clobetasone butyrate and betamethasone esters and that Synalar gel is standard treatment for steroid-responsive dermatoses in the scalp. 1 He noted that these are well-established products which should be available in any dermatological formulary. A healthy selection of topical corticosteroids ranging from mild to very potent, with or without antimicrobials, are essential as there is wide inter-patient variability in response to treatments. Relevance in therapy: Corticosteroids are synthetic analogues of the natural hormones that are produced by the adrenal cortex. Like the natural hormones, synthetic corticosteroids can have glucocorticoid and/or mineralocorticoid properties. Corticosteroids can be administered systemically (orally and parenterally) or locally (topically to the skin, nose, and eyes; by inhalation; rectally and by intra- articular injection). Local corticosteroids are predominantly glucocorticoids with anti- inflammatory, immunosuppressive, anti-proliferative (anti-mitotic) and vasoconstrictive effects. Topical corticosteroids exert these effects on the skin to treat various inflammatory skin conditions (other than those arising from an infection), such as eczema, contact dermatitis, insect stings, psoriasis, lichen planus, discoid lupus erythematosus and alopecia areata. Topical corticosteroids are also available as compound preparations containing antibacterials, antifungals and salicylic acid for use in inflammatory skin conditions associated with bacterial and fungal infection according to the sensitivity of the infecting organism and hyperkeratosis respectively. They may also be used in conjunction with other topical agents eg coal tar or dithranol. Corticosteroids are not curative.1,2 Topical corticosteroids are available in four potencies: Mild, moderately potent, potent and very potent. The potency is determined by the amount of vasoconstriction produced as well as the formulation (ointments are more potent than creams), occlusion, the salt of the steroid, the presence of other ingredients and fluorination. The occlusion involves the covering of the treatment area is by a thin polythene film which enhances effectiveness as well as local and systemic toxicity. The salt of the steroid do influence the potency as dipropionate and butyrate salts are stronger than valerate salts. The presence of other ingredients such as salicylic acid or urea and fluorination increases potency (fluorinated corticosteroids e.g. Dermovate®, Haelan®, Metosyn® and Cutivate® have increased potency).1 There are no published systematic reviews comparing the effectiveness of different topical corticosteroids. Choice of agent is made according to patient need.3 The British Association of Dermatologists states that patients who fail to respond to one topical agent may respond to another and it is worthwhile rotating different types of topical agents.4 They also noted there is lack of evidence supporting twice-daily application of topical corticosteroids to be more effective than once daily application. The choice of topical corticosteroid depends on the condition being treated and its stage, the area of the body that is affected, and the age of the person. Mild forms of dermatitis may only require a mild corticosteroid whereas psoriasis may require a more potent steroid with the most potent treatments reserved for recalcitrant dermatoses. The least potent steroid that relieves the symptoms should be prescribed, and at an appropriate quantity. Patients should be advised to spread thinly over the affected area and use the fingertip unit as a measuring guide.2 Where long-term topical corticosteroids are required, gradual 2 withdrawal of the steroid may be needed to prevent rebound exacerbation of the condition. Use of emollient helps in reduction of use of steroids and where emollient is required, the corticosteroid should be applied 30 minutes after the emollient to ensure full absorption of the emollient. Areas where the skin is thin or flexural e.g. face, scrotum, groin, axillae and submammary area, usually require a weak or moderately-potent corticosteroid whereas areas where the skin is thick e.g. palms of the hands, soles of feet, scalp, or lichenified skin due to constant scratching, typically require more potent preparations.1 Pregnancy: Mildly potent, moderately potent and potent corticosteroids, if used correctly, are suitable for use during pregnancy. Some evidence suggested that very potent corticosteroids might be associated with low birth weight and will need specialist advice.1 Breastfeeding: Mildly potent, moderately potent and potent corticosteroids are considered suitable for use during breastfeeding. If applied to the breasts, the steroid should be washed off before breastfeeding to prevent the infant ingesting it.1 Cautions: Steroids are not recommended to be applied to the face for prolonged periods or for prolonged use in children. Potent and very potent corticosteroids are recommended to be used under specialist supervision. The use of potent or very potent corticosteroids in psoriasis can result in rebound relapse, development of pustular psoriasis, and local and systemic toxicity..1,2 Contraindications: Primary infections of the skin caused by bacteria, fungi or viruses, in acne, and rosacea. Potent corticosteroids are contraindicated in plaque psoriasis.1,2 Side-effects: Long-term continuous topical steroid therapy, especially with the potent and very potent preparations can produce atrophic skin changes such as thinning of the skin, irreversible striae and telangiectasia, and even adrenal suppression and Cushing’s syndrome. Contact dermatitis, irritation at site of application, spread and worsening of untreated infection, perioral dermatitis, acne/worsening of acne or rosacea, reversible depigmentation and hypertrichosis are other local side-effects reported.1,2 Tolerance may occur in response to continued use of any topical steroid and is related to duration of use rather than potency. The British Association of Dermatologists therefore recommends that No more than 100g of a moderately potent or higher potency preparation should be applied per month. Use of very potent preparations should be under dermatological supervision. Use of fingertip unit as a measure to help patients know how much ointment or cream to apply. No topical corticosteroid should be used regularly for more than four weeks without critical review. Potent corticosteroids should not be used regularly for more than 7 days. No unsupervised repeat prescriptions should be made. Patients should be reviewed every 3 months.4 3 Table 1: Practical guidance to formulation choice of topical steroids based on the condition being treated, patient’s preference, its severity and location. 1,5 Selection of products available Formulation Formulation advantages Formulation disadvantages Body areas (not an exhaustive list) A low viscosity, alcohol- or water- Very drying if alcohol is the base, and Scalp Betnovate® based liquids. Easy to apply and non- can sting sore skin. Betacap® greasy. ® Solutions Dermovate Scalp Application A mixture of water suspended in oil, Contains preservatives in formulation, Face, limbs, trunks Cutivate® cream thicker than lotions- good which may cause irritation/allergic Flexures and genitals Elocon® cream moisturising qualities, absorb rapidly reactions. Lesser occlusive effect than Palms and soles Haelan® cream Cream into skin and cosmetically acceptable. ointments. Nerisone® cream Useful for exudating (weepy) and moist areas. Less greasy and occlusive. Has a jelly- Lesser occlusive effect than creams and Face, Limbs, Trunk Synalar® gel like consistency, beneficial for ointments. Flexures and genitals Gel exudative inflammation and does not