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 Investigatorâ€™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