1. 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
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Jemec GB, Ganslandt C, Ortonne JP, Poulin Y, Burden AD, de Unamuno P, Berne B, Figueiredo A, and Austad J
- Subjects
- Administration, Cutaneous, Adolescent, Adult, Aged, Aged, 80 and over, Betamethasone administration & dosage, Betamethasone adverse effects, Calcitriol administration & dosage, Calcitriol adverse effects, Double-Blind Method, Drug Combinations, Female, Humans, Male, Middle Aged, Pharmaceutical Vehicles, Psoriasis pathology, Scalp Dermatoses pathology, Severity of Illness Index, Skin pathology, Treatment Outcome, Anti-Inflammatory Agents administration & dosage, Betamethasone analogs & derivatives, Calcitriol analogs & derivatives, Dermatologic Agents administration & dosage, Psoriasis drug therapy, Scalp Dermatoses drug therapy
- Abstract
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.
- Published
- 2008
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