INTRODUCTION
Calcipotriene 0.005% (Calc), a vitamin D analog, plus betamethasone dipropionate 0.064% (BD), a high potency topical corticosteroid, are combined in an aerosol foam formulation (Calc/BD AF) that has been shown to be effective and safe for the topical treatment of plaque psoriasis (CPPso).1 Application once daily of Calc/BD AF for up to 4 weeks is approved by the United States Food and Drug Administration (US FDA) since 2006 for treatment of plaque psoriasis in patients ≥18 years of age.1 Efficacy, tolerability, and safety have been demonstrated with once daily application of Calc/BD AF for CPPso on the trunk, extremities, and scalp, with marked and rapid reduction in pruritus also observed.2-5 Importantly, Calc/BD AF has proven to provide superior efficacy outcomes in CPPso as compared to both the ointment and the gel vehicles.3,4,6,7 A retrospective evaluation from 24 dermatology centers in the US supports the efficacy of Calc/BD AF, including reduction of pruritus, in patients with CPPso, with elbows and knees the most common sites treated.8 However, the pivotal studies with Calc/BD AF did not include elbows and knees in the target lesion evaluations, resulting in a data gap related to these commonly affected anatomic sites.This article reports outcomes from an investigator-initiated study (IIS) using an open-phase design that evaluated the use of Calc/BD AF once daily in adults with CPPso of moderate severity. A major objective of this IIS was documentation of clinical response on the elbows and knees.
METHODOLOGY
This IIS was a two-center, open-label, 4-week pilot study of male or female adult subjects ≥18 years of age with CPPso affecting 3% to 20% body surface area (BSA). Enrolled subjects were evaluated for clinical response, tolerability, and safety at baseline, week 2, and week 4. Enrolled subjects were required to be affected by CPPso, with a baseline Physician Global Assessment (PGA) rating of moderate severity (PGA=3), and bilaterally symmetric target lesion plaques measuring 2 cm to 4 cm in diameter involving the elbows and/or knees. The PGA rating scale used in the IIS is depicted in Table 1.Target lesions were identified by the investigator on either elbows or knees using the Target Lesion Severity Score (TLSS) cumulative rating system (Table 2); TLSS scores were documented at baseline and all subsequent visits. At baseline, the minimum cumulative TLSS required for enrollment was 6, with at least an individual severity score of 2 for each parameter that was independently evaluated (erythema, scaling, induration [plaque thickness]). Target lesions were photographed at each visit at one site (JDR).Conventional inclusion and exclusion criteria were followed as defined in the study protocol. Washout periods included 2 weeks for topical anti-psoriatic agents, 4 weeks for non-biologic systemic therapies, 3 months for biologic therapies, and 2 weeks for phototherapy. Pregnancy, breast-feeding, and lack of reliable contraception in women of child-bearing potential
