A Novel Formulation of Mometasone Furoate in Psoriasis Patients: A Multicenter, Randomized, Double-Blind Clinical Study

Further formulations of mometasone furoate are needed for treatment of patients with plaque psoriasis to meet individual patient preferences. This has motivated the development of Ovixan(A (R)) (Galencia, Malmoe, Sweden), a formulation of mometasone furoate with different cosmetic properties than the commonly used formulation, Elocon(A (R)) (Merck [Schering Plough], Whitehouse Station, New Jersey, USA). This novel formulation of mometasone furoate was examined in a vasoconstrictor assay comparing its efficacy with that of Elocon. Subsequently, the new formulation was tested in a multicenter, randomized, double-blind clinical study in patients with plaque psoriasis. Healthy volunteers were included in the vasoconstrictor study. The treatments were randomly assigned to test fields on the forearms. The test fields were gently cleaned after treatment for 6 h. Skin color was measured during the following 24 h and area under the time curve was calculated. The clinical efficacy and tolerance of Ovixan was as compared to that of Elocon and their vehicles in a double-blind study in patients with plaque psoriasis. Patients with four symmetrically placed lesions on the arms or the legs were treated for 6 weeks. Primary endpoint was the change from baseline of the Total Severity Sign score for each treated lesion. The cosmetic characteristics of the two test preparations were assessed by an independent cosmetological institute. Ovixan was shown to have skin blanching potency almost identical to the vasoconstrictor potency of Elocon. Clinical equivalence of Ovixan to Elocon was demonstrated in the clinical study of the efficacy in patients with plaque psoriasis. A professional testing team clearly documented the cosmetic superiority of Ovixan as compared to Elocon. The results of the investigations show that Ovixan is equipotent to the commonly used formulation Elocon. However, the cosmetic properties are in favor of Ovixan. The effect of the cosmetic differences on patient preferences and patient adherence to prescribed treatment has to be investigated in further studies