Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts, WD17 1DS, UK
Pharmacotherapeutic group: Corticosteroids, Very Potent (Group IV)
ATC code: D07AD01
Like other topical corticosteroids, clobetasol propionate has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of topical corticosteroids in general is unclear. However, corticosteroids are thought to act by induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.
In vitro liberation –penetration studies on human skin showed that only a small percentage (0.1%) of the applied dose of Etrivex Shampoo can be found in the epidermis (including the stratum corneum) when applied for 15 minutes and then rinsed. The very low topical absorption of clobetasol propionate from Etrivex Shampoo when applied according to the recommended clinical use (15 minutes before rinse off) resulted in negligible systemic exposure in animal studies and in clinical trials. Available clinical data revealed that only 1 of 126 subjects had a quantifiable clobetasol propionate plasma concentration (0.43 ng/ml).
The present pharmacokinetic data indicate that systemic effects following clinical treatment with Etrivex Shampoo are highly unlikely due to the low systemic exposure of clobetasol propionate after topical administration.
Non clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single, repeated dose toxicity and genotoxicity. The carcinogenicity of clobetasol has not been studied.
In rabbits, Etrivex Shampoo was slightly irritating to the skin and eyes, but no delayed-type hypersensitivity was seen on guinea pigs' skin.
In developmental toxicity studies in the rabbit and the mouse, clobetasol propionate was shown to be teratogenic when administered subcutaneously at low doses. In a topical embryotoxicity study of clobetasol in the rat, foetal immaturity and skeletal and visceral malformations were observed at relatively low dosage levels. In addition to malformations, studies in animals exposed to high systemic levels of glucocorticoids during pregnancy have also shown other effects on the offspring, such as intrauterine growth retardation.
The clinical relevance of the effects of clobetasol and other corticosteroids in developmental animal studies is unknown.
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