CLOBEX

What it is

Clobex is a shampoo containing 500 micrograms of clobetasol propionate per millilitre. It is a shampoo for topical application. The formulation contains alcohol as 10% v/v ethanol.

Approved indications

— Topical treatment of moderate to severe scalp psoriasis in adults.

Dosing overview

Clobex Shampoo should be applied directly on dry scalp once daily, taking care to cover and massage the lesions well. Using the measuring cup included, measure out 7.5 mL which is sufficient to cover all the scalp and is the maximum daily dosage. Clobex Shampoo should be left in place without covering for 15 minutes before rinsing. The treatment duration should be limited to a maximum of 4 weeks.

Key safety warnings

Clobetasol propionate belongs to the most potent class of topical corticosteroids (class IV) and prolonged use may result in serious undesirable effects. Topical corticosteroids should be used with caution due to post treatment rebound, relapses, development of tolerance and development of local or systemic toxicity such as skin atrophy, infection, telangiectasia or hypothalamic-pituitary-adrenal (HPA) axis suppression. There is a risk of HPA suppression with prolonged use and also with the use of large volumes. Clobex Shampoo should not be used for more than 4 consecutive weeks; nor should a dose greater than 7.5 mL daily be used. Systemic absorption of topical corticosteroids has caused reversible adrenal suppression with the potential for glucocorticosteroid insufficiency, manifestations of Cushing's syndrome, hyperglycaemia, and glucosuria in some patients. Such systemic effects disappear when treatment is stopped. However, abrupt discontinuation can lead to acute adrenal insufficiency, especially in children. Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy.

Contraindications

Clobex Shampoo is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients, and in skin areas affected by bacterial and mycobacterial, viral (varicella, herpes simplex, herpes zoster), fungal or parasitic infections and specific skin diseases (skin tuberculosis, skin diseases caused by lues) or ulcerous wounds. Clobex Shampoo must not be applied to the eyes and eyelids due to risk of glaucoma and risk of cataract. Clobex Shampoo is contraindicated in children under 2 years of age.

Regulatory history

Clobex shampoo received approval on 2013-02-06 for topical treatment of moderate to severe scalp psoriasis in adults. The product was first listed on the Australian Register of Therapeutic Goods (ARTG 188346) on 2013-03-21. The submission was approved despite some outstanding quality control issues that necessitated an initial short shelf life, with the TGA identifying outstanding chemistry and quality control aspects that required a future variation application.