Eumovate (clobetasone butyrate 0.05%) cream: a review of clinical efficacy and safety.
Topical steroid creams and ointments have been available as over-the-counter (OTC) medications for the self treatment of acute dermatitis and other steroid responsive skin disorders for more than ten years. Despite earlier fears, widespread availability and use of these creams is not associated with clinically significant adverse effects. In dermatological practice, hydrocortisone 1% remains the mainstay of treatment for facial eczema, but it is often not effective in eczema affecting other body areas. Eumovate(TM) (clobetasone butyrate 0.05%) cream has recently been made available as a pharmacy medication for the short-term management of acute eczema and allergic dermatitis by adults and children aged 10 or older, based on evidence derived from clinical trials involving over 3500 patients. This review summarises the key efficacy and safety data derived from 29 clinical trials and the post-licensing pharmacovigilance safety information, which supported the reclassification of this product for OTC use. These data show clobetasone butyrate 0.05% is more effective than 1.0% hydrocortisone in the treatment of eczema and more effective than flurandrenolone 0.0125% (p=0.01%) and a potent topical steroid hydrocortisone butyrate (p<0.05), in the treatment of psoriasis. A review of the effect of topical steroids on skin thickness concluded that, following short term application, there was no clinically significant difference between hydrocortisone 1.0% and clobetasone butyrate 0.05% in terms of potential for skin thinning. Similarly, even under extreme conditions, clobetasone butyrate 0.05% has negligible systemic absorption and has almost no effect on HPA axis function.
Goustas
P
P
GlaxoSmithKline, Great West Road, Brentford, Middlesex TW8 9GS, UK. peter.c.goustas@gsk.com
Cork
M J
MJ
Higson
D
D
D000208:Acute Disease; D000279:Administration, Cutaneous; D000287:Administration, Topical; D016907:Adverse Drug Reaction Reporting Systems; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002990:Clobetasol / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D003872:Dermatitis / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage / Q000627:therapeutic use; D004366:Nonprescription Drugs; D009824:Ointments; D016032:Randomized Controlled Trials as Topic; D012651:Self Medication
D000893:Anti-Inflammatory Agents; D004366:Nonprescription Drugs; D009824:Ointments; C010893:clobetasone butyrate; D002990:Clobetasol; D006854:Hydrocortisone