Overview on desonide 0.05%: a clinical safety profile

Journal of Drugs in Dermatology, July-August, 2004 by Vicky Kwan Wong, Brian Fuchs, Mark Lebwohl

Even though the mean body surface area treated was quite high in both groups (desonide 38.1% and hydrocortisone 37.1%), there was no drug-induced suppression of early morning cortisol levels after four weeks of either treatment. Likewise, adrenocorticotropic hormone-stimulated mean cortisol values were not significantly different from baseline in either group (Figure 2). The authors concluded that the use of 0.05% desonide or 2.5% hydrocortisone ointment for four weeks has no adverse effect on the HPA axis of children. They emphasize that an assumption of safety may also be made for other less occlusive formulations such as lotions or creams.

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Desonide for Seborrheic Dermatitis

A double-blind, bilateral within-patient study to compare the dermal/epidermal safety of desonide cream 0.05% with hydrocortisone cream 1% in 29 adult patients with seborrheic dermatitis of the scalp was conducted by Cornell and Baker (7). Treatment was applied twice daily for eight weeks to the postauricular region (an area of naturally thin skin).

Assessment for signs of skin atrophy, made at baseline and at weeks 1, 2, 4, 6 and 8, included telangiectasia (count of the blood vessels in the application area), epidermal thinning, striae and shiny surface appearance, the presence or absence of hair loss, muscle waste, fat waste, loss of elasticity or skin markings, and purpura or bruising.

After eight weeks, the total number of telangiectasia, while few in number, was greater on the hydrocortisone treated sites than on the desonide sites. There were no signs of skin atrophy and all other safety variables were negative. The study therefore demonstrated that 0.05% desonide cream has a dermal safety profile comparable to that of 1.0% hydrocortisone cream.

Discussion and Conclusions

Desonide 0.05%, formulated as a cream or ointment, has been available since the early 1970s for the treatment of mild to moderate steroid-responsive dermatoses. Recently the range has extended to include a 0.05% lotion. With launches into additional markets imminent, the three products making up the desonide range will soon have a truly global exposure.

This overview presents the results of a comprehensive pharmacovigilance program that has been rigorously collecting post-marketing surveillance data on desonide for almost a decade. It demonstrates that the incidence of adverse events associated with the use of topical desonide 0.05% is low indeed. The majority (66%) of the 62 adverse events reported were local reactions of a type to be expected with topical corticosteroid preparations, and medical confirmation was available for only 40% of all reports. Bearing in mind the considerable volume of sales of desonide products (almost a million packs sold each year in the US alone), the reports of generally mild adverse events in only 62 people in nine years between 1992 and 2000, suggests that the safety of this product, regardless of formulation, is excellent.

Two of the reported adverse events deserve additional mention. Hypochromia and "bleaching" are known effects of topical corticosteroids. While the causal link with desonide is unknown here, these effects are readily reversible when responsible corticosteroids are discontinued. Cataracts have also been reported with topical corticosteroid use, but they are also increased in atopic dermatitis. Moreover, the solitary report of cataracts here is less than would be expected given the large number of units of desonide sold.