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
March 2013 | Volume 12 | Issue 3 | Original Article | 300 | Copyright © 2013
Steven R. Feldman MD PhD,a William J. Eastman MD,b Thomas Brundage MS,b and Mary Mills BSb
aDepartments of Dermatology, Pathology & Public Health Sciences, Wake Forest University School of Medicine, Winston-Salem, NC bStiefel, a GSK company, Research Triangle Park, NC
BACKGROUND: Calcipotriene ointment and cream are effective treatments for psoriasis, but many patients with scalp psoriasis prefer lighter, less messy vehicles.
OBJECTIVES: To evaluate the efficacy and safety of calcipotriene foam, 0.005%, for plaque-type psoriasis of the scalp.
METHODS: 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.
RESULTS: 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.
CONCLUSION: 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.
J Drugs Dermatol. 2013;12(3):300-306.
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Topical treatment options for plaque-type psoriasis include vitamin D3 analogues, corticosteroids, and topical retinoids.1,2 When hair-bearing areas are involved, treatment with topical agents becomes more challenging, as application may be difficult or unpleasant, possibly resulting in reduced adherence leading to reduced efficacy.3,4 Vehicle choice for topical agents may also influence patient adherence.3,5
Calcipotriene, a vitamin D3 analogue,6 was approved in 1993 and calcipotriene foam, 0.005%, in 2010 for the topical treatment of plaque psoriasis in adults. Foam vehicles have greater bioavailability compared with ointments and solutions7,8 and the cosmetic aspects of a foam delivery system, eg, low residue and nongreasy, may be associated with increased patient adherence.5
The primary objective of this study was to evaluate the efficacy and safety of calcipotriene foam, 0.005%, compared with vehicle foam in the treatment of plaque-type psoriasis of the scalp.
This was a randomized, multicenter, double-blind, vehicle- controlled, parallel-group, phase 3b study of the efficacy and safety of calcipotriene foam, 0.005% (Sorilux™; Stiefel, Research Triangle Park, NC) vs vehicle foam in the treatment of plaque-type psoriasis of the scalp (ClinicalTrials.gov identifier NCT01139580). The study was performed in accordance with Good Clinical Practice and the guiding principles of the Declaration of Helsinki, and had institutional review board approval. Participants were recruited from 26 treatment centers in the United States.
Subjects aged 12 years and older were eligible for the study if they had plaque-type psoriasis involving 3% to 10% of total body surface area (BSA), excluding the scalp and face, with an Investigator’s Static Global Assessment (ISGA) score of 3 at baseline; a discrete, evaluable target lesion of greater than 2 cm2 on the trunk or extremities with a score of 2 or 3 for erythema, scaling, and plaque thickness on the psoriasis grading scale; and plaque-type psoriasis on 10% or more of the total scalp surface area, with an ISGA score of 3 at baseline. Female subjects of childbearing potential required a negative urine pregnancy test and agreed to use a medically acceptable method of contraception. Exclusion criteria included participation in any previous clinical study concerning calcipotriene foam; use of nonbiologic systemic antipsoriatic therapy; recent use of topical therapies with