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

Kerkhof P C M van de, Hoffmann V, Anstey A, Barnes L, Bolduc C, Reich K, Saari S, Segaert S, Vaillant L

Br J Dermatol 2009; 160(1): 170-176
http://dx.doi.org/10.1111/j.1365-2133.2008.08927.x

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 (n = 568), betamethasone dipropionate 0·5 mg g−1 (n = 563), or calcipotriol 50 μg g−1 (n = 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%, P = 0·0079) or calcipotriol (43·4%, P < 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%, P = 0·0006) or calcipotriol (44·7%, P < 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.