A multicenter, randomized, double-blind study of the efficacy and safety of calcipotriene foam, 0.005%, vs vehicle foam in the treatment of plaque-type psoriasis of the scalp.

Calcipotriene ointment and cream are effective treatments for psoriasis, but many patients with scalp psoriasis prefer lighter, less messy vehicles. To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp. Subjects (n=363) were randomized into an 8-week, multicenter, double-blind, vehicle-controlled, parallel-group, phase 3b study of calcipotriene foam, 0.005% (NCT01139580). Primary end point was the proportion of subjects with an Investigator's Static Global Assessment (ISGA) score of 0 (clear) or 1 (almost clear) at week 8 for scalp involvement. Body involvement, target lesion score, and improvement for erythema, scaling, and plaque thickness were also assessed.
At week 8, more subjects in the calcipotriene foam, 0.005% group (40.9%) met the primary end point vs the vehicle foam group (24.2%; intent-to-treat [ITT] population; P <.001); a significant difference between groups was also observed at weeks 2 (P = .041) and 4 (P <.001). No significant difference was observed between treatment groups for ISGA of body psoriasis (ITT population; P = .544). In the per-protocol population, but not the ITT population, more subjects in the calcipotriene foam, 0.005%, group than the vehicle foam group met the secondary end points for scaling (P = .019) and plaque thickness (P =.027). Incidence of adverse events in both treatment groups was low; calcipotriene foam, 0.005%, was associated with erythema. Limitations: An 8-week study provides limited safety and efficacy data.
Calcipotriene foam, 0.005%, was more effective than vehicle foam for improving scalp psoriasis over an 8-week period, with improvements evident from week 2, and had a similar safety profile to vehicle foam.

Citation

Steven R Feldman, Mary Mills, Thomas Brundage, William J Eastman. A multicenter, randomized, double-blind study of the efficacy and safety of calcipotriene foam, 0.005%, vs vehicle foam in the treatment of plaque-type psoriasis of the scalp. Journal of drugs in dermatology : JDD. 2013 Mar;12(3):300-6

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PMID: 23545912

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