XOBET

What it is

Xobet is clobetasol propionate cream containing 0.5 mg of clobetasol propionate per gram. It is a white or almost white cream. Clobetasol propionate belongs to the most potent class of topical corticosteroids (Class IV).

Approved indications

— Short-term treatment of resistant or severe inflammatory and pruritic manifestations of steroid responsive dermatoses, including psoriasis (excluding widespread plaque psoriasis), recalcitrant dermatoses, lichen sclerosus/planus and discoid lupus erythematosus in adults.

Dosing overview

Apply thinly and gently rub in using only enough to cover the entire affected area once or twice a day. Treatment should not be continued for more than 2 weeks, and the maximum weekly dose should not exceed 14 g/week. Reduce the frequency of application or change the treatment to a less potent preparation once improvement occurs.

Key safety warnings

Patients receiving super-potent corticosteroids should not be treated for more than 2 weeks at a time, and only small areas should be treated at any one time due to the increased risk of hypothalamic-pituitary-adrenal (HPA) axis suppression. There is a risk of HPA suppression with prolonged use and also with the use of large volumes. Xobet Cream produced HPA axis suppression when used at doses as low as 2 g/day for 1 week in patients with eczema. Cases of osteonecrosis, serious infections (including necrotising fasciitis), and systemic immunosuppression (sometimes resulting in Kaposi's sarcoma lesions) have been reported with long-term use of clobetasol propionate beyond the recommended doses. Application to the face is undesirable as this area is more susceptible to atrophic changes. If used on the face, treatment should be limited to only 5 days. Long-term continuous or inappropriate use of topical steroids can result in the development of rebound flares after stopping treatment. A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area.

Contraindications

Xobet Cream is contraindicated in patients with hypersensitivity to the active substance or to any excipients. Clobetasol propionate is contraindicated in dermatoses in children under one year of age, including dermatitis and nappy eruptions. The following conditions should not be treated with Xobet Cream: cutaneous infections (bacterial and mycobacterial, viral including varicella, herpes simplex, herpes zoster, fungal or parasitic), ulcerous wounds, rosacea, acne vulgaris, pruritus without inflammation, perianal and genital pruritus, and perioral dermatitis.

PBS listing

Xobet 0.05% cream and ointment were recommended by PBAC in November 2024 for corticosteroid responsive dermatoses on the General Schedule as a Restricted Benefit listing, cost-minimised against betamethasone dipropionate cream and ointment, with supply limited to 2 weeks at a time.

Regulatory history

Xobet Cream clobetasol propionate 0.05% w/w cream was first listed on the Australian Register of Therapeutic Goods on 20 December 2023. Xobet is subject to additional monitoring in Australia.