The placebo-controlled trial demonstrated that Alitretinoin was effective in patients suffering from severe and refractory chronic hand dermatitis, as determined by the stringent endpoint of clear and almost clear hands. Currently, no approved treatment is available for this disease.
The company added that these positive data will form the basis of regulatory submissions later this year. In the study, 1,032 patients whose severe chronic disease was unresponsive to potent topical steroids were randomized either to a once-daily dose of 30mg or 10mg of Alitretinoin, or placebo, for a treatment duration of up to 24 weeks. Alitretinoin's efficacy was significantly superior to placebo in both the high- and the low-dose regimen.
Alitretinoin was generally well tolerated with a safety profile consistent with that reported in the phase II clinical study. The most frequent adverse events were headache and blood lipid elevations. These were dose-dependent and reversible.