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Calcipotriol plus betamethasone dipropionate gel compared with its active components in the same vehicle and the vehicle alone in the treatment of psoriasis vulgaris: a randomised, parallel group, double-blind, exploratory study.

Author(s): Fleming C, Ganslandt C, Guenther L, Johannesson A, Buckley C, Simon JC, Stegmann H, Vestergaard Tingleff L

Affiliation(s): Ninewells Hospital and Medical School, Dundee, United Kingdom, LEO Pharma A/S, Industriparken 55, 2750 Ballerup, Denmark.

Publication date & source: 2010-07, Eur J Dermatol., 20(4):465-71. Epub 2010 Apr 23.

Publication type: Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

A two-compound ointment containing calcipotriol plus betamethasone dipropionate is an effective treatment for psoriasis vulgaris. The same active ingredients have now been combined in a gel formulation. Our objective was to compare the efficacy and safety of once daily treatment of the two-compound gel with the single components in the same gel vehicle and the gel vehicle alone, in patients with psoriasis vulgaris on the trunk and/or limbs. 364 patients received once daily treatment for up to 8 weeks with either the two-compound gel, the single components in the gel vehicle or the gel vehicle alone. The percentage of patients whose disease was clear or very mild and who had at least a two-step improvement in the Investigator's Global Assessment of disease severity at week 8, was significantly higher with calcipotriol plus betamethasone dipropionate (27.2%) than with betamethasone dipropionate (16.9%, p = 0.027), calcipotriol (11.4%, p = 0.006) or gel vehicle (0.0%, p < 0.001). This exploratory study showed that the two-compound gel was safe and more efficacious than its individual ingredients in the treatment of psoriasis vulgaris.

Page last updated: 2010-10-05

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