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

BackgroundNew topical treatments in scalp psoriasis are needed because many current topical treatments are disliked by patients and associated with poor compliance.ObjectiveTo 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.MethodsIn this 8-week, multicenter, randomized, double-blind study, patients with scalp psoriasis were randomized to treatment with the two-compound scalp formulation (calcipotriene 50 μg/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 μg/g in the same vehicle (n = 272), or vehicle alone (n = 136).ResultsMore 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).LimitationsEfficacy of the active comparators in the study has not been established in relation to calcipotriene and betamethasone formulations available for clinical use.ConclusionCalcipotriene plus betamethasone dipropionate scalp formulation was more effective than either of the individual components or the vehicle alone.