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A new scalp formulation of calcipotriol plus betamethasone dipropionate compared with each of its active ingredients in the same vehicle for the treatment of scalp psoriasis: a randomized, double-blind, controlled trial

Authors


  • Conflicts of interest
    P.C.M.v.d.K. with Abbott, Allmiral, Barrier, Cellgene, Centocor, Galderma, LEO Pharma, Pfizer, Serono, UCB Pharma and Wyeth. V.H. is an employee of LEO Pharma. This study was sponsored by LEO Pharma.

  • Data collection took place at all the above institutions. A list of participating investigators is provided at the end of this article.

Peter van de Kerkhof.
E-mail: vandekerkhof@derma.azn.nl

Summary

Background  There is a need for new treatments for scalp psoriasis, as many topical treatments are cosmetically unacceptable and difficult to apply, resulting in poor compliance.

Objectives  To compare the efficacy and safety of a new, once-daily, two-compound scalp formulation (Xamiol®; LEO Pharma A/S, Ballerup, Denmark) containing calcipotriol 50 μg g−1 plus betamethasone 0·5 mg g−1 (as dipropionate), with the active ingredients as single compounds in the same vehicle.

Methods  This 8-week, multicentre, double-blind, parallel-group study, randomized adult patients with scalp psoriasis involving > 10% of the scalp to the two-compound scalp formulation (= 568), betamethasone dipropionate 0·5 mg g−1 (= 563), or calcipotriol 50 μg g−1 (= 286). The primary efficacy measure was the proportion of patients with ‘absence of disease’ or ‘very mild disease’ according to investigators’ assessments at week 8.

Results  The proportion of patients with ‘absence of disease’ or ‘very mild disease’ at week 8 was significantly higher in the two-compound group (68·4%) than the betamethasone dipropionate (61·0%, = 0·0079) or calcipotriol (43·4%, < 0·0001) groups. The proportion of patients rating their scalp psoriasis as ‘clear’ or ‘almost clear’ was significantly higher for the two-compound scalp formulation (69·6%) than for betamethasone dipropionate (59·9%, = 0·0006) or calcipotriol (44·7%, < 0·0001). The incidence of lesional/perilesional adverse events was lower in the two-compound and betamethasone dipropionate groups than the calcipotriol group.

Conclusions  The two-compound scalp formulation was well tolerated and more effective in the treatment of scalp psoriasis than either of its individual components in the same vehicle.

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