Data from pharmawand - Curated by Toby Galbraith - Date added 12 April 2012
Topline results were reported from the U.S. Phase III 596 patient HANDEL study of Toctino(alitretinoin) from Basilea Pharma in severe
Chronic Hand Eczema refractory to potent topical corticosteroids. Patients with severe Chronic Hand Eczema unresponsive to potent topical corticosteroids were randomized either to a once-daily dose of 30 mg alitretinoin or placebo for a treatment duration of up to six months. At the end of treatment, 40% of patients treated with alitretinoin achieved "clear" or "almost clear" hands compared to 15% treated with placebo (p<0.001) based on the primary outcome measure Physician Global Assessment (PGA) in the intent-to-treat population, thereby achieving the primary study objective. Basilea plans to discuss the final study results and the requirements for a risk evaluation and mitigation strategy with the FDA in the second half of 2012 in the context of a potential filing of a New Drug Application in the USA.