Early onset of action and efficacy of a combination of calcipotriene and betamethasone dipropionate in the treatment of psoriasis.

Author(s): Papp KA, Guenther L, Boyden B, Larsen FG, Harvima RJ, Guilhou JJ, Kaufmann R, Rogers S, van de Kerkhof PC, Hanssen LI, Tegner E, Burg G, Talbot D, Chu A

Affiliation(s): Probity Medical Research, Waterloo, Ontario, Canada. kapapp@probitymedical.com

Publication date & source: 2003-01, J Am Acad Dermatol., 48(1):48-54.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

BACKGROUND: Calcipotriene and betamethasone dipropionate are topical treatments for psoriasis vulgaris. Their mode of action is different. Improved risk/benefit may result with concomitant use of the two compounds together. A new vehicle has been created with the objective of obtaining optimal stability of both calcipotriene and betamethasone dipropionate in the combination product. OBJECTIVE: We compared the clinical efficacy of a fixed combination of calcipotriene and betamethasone dipropionate in a new vehicle to calcipotriene in the new vehicle, betamethasone in the new vehicle, and the new vehicle alone. METHODS: This was an international, multicenter, prospective, randomized, double-blind, parallel-group, 4-week study in patients with psoriasis vulgaris amenable to topical treatment. RESULTS: The mean percentage reduction in PASI from baseline to end of treatment was 73.2% in the combination group (n = 301), 48.8% in the calcipotriene group (n = 308), 63.1% in the betamethasone dipropionate group (n = 312) and 28.8% in the new vehicle group (n = 107), (P < .001). The mean percentage reduction in PASI during the first week was 48.1%, 28.4%, 41.4%, and 21.5%, respectively (P < .001). CONCLUSION: A combination product of calcipotriene 50 microg/g and betamethasone dipropionate 0.5 mg/g in the new vehicle shows superior efficacy with a more rapid onset of action than the new vehicle containing either constituent alone in the treatment of psoriasis vulgaris.