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 - 24/04/13
, Cecilia Ganslandt, MD b, Jean-Paul Ortonne, MD c, Yves Poulin, MD d, A. David Burden, MD e, Pablo de Unamuno, MD f, Berit Berne, MD g, Américo Figueiredo, MD h, Joar Austad, MD i
Reprint requests: Gregor B. E. Jemec, MD, Department of Dermatology, Roskilde Sygehus, Køgevej 7-13, DK-4000 Roskilde, Denmark.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 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).
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.
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| Study sponsored by LEO Pharma A/S, Ballerup, Denmark. |
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| Dr Jemec has received grants, as an investigator, from Abbott, Astion, LEO Pharma, UCB, and Wyeth and has served on the Advisory Board for Abbott and Wyeth, and for Astion, Schering-Plough and Merck Serono, from whom he received honoraria for his participation. Dr Ganslandt is a salaried employee of LEO Pharma. Dr Ortonne has received honoraria in his capacity as an investigator for LEO Pharma and for consultancy work from Abbott, Galderma, Merck Serono, Schering-Plough, and Wyeth. Dr Poulin has received grants, as an investigator, from Abbott, Advitech, Amgen, Astellas-Biogen, Boehringer, Celgene, Centocor, Dermik, Galderma, GlaxoSmithKline, Isotechnika, LEO Pharma, and Merck Serono. Dr Poulin has also received honoraria for advisory board participation (Amgen), speaking engagements (Abbott, Merck Serono, and Schering) and consultancy work (Merck Serono and Schering). Dr Burden has received honoraria for Advisory Board participation (LEO Pharma) but no compensation in his role as an investigator for LEO Pharma. Dr Unamuno has nothing to disclose. Drs Berne and Figueiredo have served as investigators for LEO Pharma. Dr Austad has received honoraria for being an investigator and for speaking for LEO Pharma. |
Vol 59 - N° 3
P. 455-463 - septembre 2008 Retour au numéro
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