AusPAR: Clobetasol propionate - Therapeutic Goods Administration

Therapeutic Goods AdministrationTable 4. Incidence of HPA axis suppression with various CP productsFor all marketed formulations of CP globally, it is agreed that the dose should not exceed50 g/week and that treatment should be limited to a maximum of 4 consecutive weeks andrestricted to adults. There are currently no other restrictions, such as minimal durationbetween two courses of treatment, for the safe use of leave-on CP formulations inpsoriasis. There have been published case reports in which adrenal insufficiency has beenrecorded after stopping treatment with potent topical corticosteroids but these wereinvariably secondary to prolonged use (over four continuous weeks) of excessive dosesand frequently in the paediatric population. 19The scalp is a common site of disease involvement during psoriasis which is difficult totreat as the application of creams or ointments directly onto lesions is hampered by theoverlying hair. Other types of formulations such as lotions, gels and foams may leave thehair sticky and greasy. Due to the limitations of current therapies, compliance withtreatments for the scalp is frequently low. In order to provide patients with scalp psoriasisand the physicians who treat them a more convenient and efficient topical treatment,Galderma has developed Clobex shampoo.Clobex Shampoo meets two objectives:• To reduce the systemic distribution of CP while maintaining clinical efficacy, throughthe strategy of short contact corticosteroid therapy (duration of application of 15minutes followed by a thorough rinsing of the hair and scalp)19 Tempark T.et al. Exogenous Cushing’s syndrome due to topical corticosteroid application: case reportand review literature. Endr (2010) 38:328-334AusPAR Clobex clobetasol propionate Galderma Australia Pty Ltd PM-2011-01596-3-5Final 22 May 2013Page 41 of 45