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A new scalp formulation of calcipotriene plus betamethasone compared with its active ingredients and the vehicle in the treatment of scalp psoriasis: a randomized, double-blind, controlled trial.

Author(s): Jemec GB, Ganslandt C, Ortonne JP, Poulin Y, Burden AD, de Unamuno P, Berne B, Figueiredo A, Austad J

Affiliation(s): Department of Dermatology, Health Sciences Faculty University of Copenhagen, Roskilde Hospital, Roskilde, Denmark. gbj@regionsjaelland.dk

Publication date & source: 2008-09, J Am Acad Dermatol., 59(3):455-63.

Publication type: Comparative Study; Multicenter Study; Randomized Controlled Trial

BACKGROUND: New topical treatments in scalp psoriasis are needed because many current topical treatments are disliked by patients and associated with poor compliance. OBJECTIVE: To compare the efficacy and safety of once-daily, two-compound scalp formulation containing calcipotriene plus betamethasone dipropionate with the individual components in the same vehicle and the vehicle alone. METHODS: In this 8-week, multicenter, randomized, double-blind study, patients with scalp psoriasis were randomized to treatment with the two-compound scalp formulation (calcipotriene 50 microg/g plus betamethasone 0.5 mg/g, as dipropionate) (n = 541), betamethasone 0.5 mg/g (as dipropionate) in the same vehicle (n = 556), calcipotriene 50 microg/g in the same vehicle (n = 272), or vehicle alone (n = 136). RESULTS: More patients achieved "absent" or "very mild" disease at week 8 with the two-compound scalp formulation (71.2%) compared with betamethasone dipropionate in the same vehicle (64.0%, p = .011), calcipotriene in the same vehicle (36.8%, p < .0001), or the vehicle (22.8%, p < .0001). LIMITATIONS: Efficacy of the active comparators in the study has not been established in relation to calcipotriene and betamethasone formulations available for clinical use. CONCLUSION: Calcipotriene plus betamethasone dipropionate scalp formulation was more effective than either of the individual components or the vehicle alone.

Page last updated: 2008-11-03

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