INTRODUCTION
Psoriasis is a chronic, immune-mediated, inflammatory condition affecting mainly the skin and joints, with a prevalence of approximately 2%.1 Data suggest that the scalp is affected in up to 79% of patients with psoriasis2 and that this frequency increases with duration of the disease.3 Scalp psoriasis can cause impairment of hair growth, potentially resulting in scarring and alopecia,4 and is associated with considerable psychological and social distress in a majority of patients, with itch and scaling the most frequent and distressing symptoms.2,5 Approximately 80% of psoriasis patients have mild-to-moderate disease which, in the majority of cases, is treated topically; the scalp is considered a difficult-to-treat area.1,5,6 Standard first-line topical interventions are topical corticosteroids, often combined with vitamin D3 analogues.5 Skin atrophy, a well-known side effect of steroid treatment, is rarely observed in the scalp, possibly because of its dense vascularization and abundance of adnexal structures.7
Relatively few published studies have evaluated the use of topical treatments in scalp psoriasis. Here we report the effect of a fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD) on scalp psoriasis in patients enrolled in two multicentre Phase 2 studies. Positive efficacy results on body psoriasis from these patients have already been published.8,9
Relatively few published studies have evaluated the use of topical treatments in scalp psoriasis. Here we report the effect of a fixed-dose combination foam containing calcipotriene monohydrate (Cal) and betamethasone dipropionate (BD) on scalp psoriasis in patients enrolled in two multicentre Phase 2 studies. Positive efficacy results on body psoriasis from these patients have already been published.8,9
METHODS
Both Phase 2 studies enrolled patients with psoriasis vulgaris of the body and scalp classified as at least mild according to the Physician Global Assessment (PGA), with psoriasis of the scalp affecting ≥10% of the total scalp area, psoriasis on the trunk and limbs affecting ≥2% of body surface area (BSA), and overall psoriatic involvement of the trunk, limbs and scalp ≤30% of total BSA. One trial (NCT01536938) enrolled patients aged ≥18 years who had experienced psoriasis for a period of ≥6 months. The second trial (NCT02387853) enrolled adolescent patients aged 12 to <17 years. Key eligibility criteria have been reported previously.8,9 In the adult trial, 302 patients were randomly assigned in a 1:1:1 ratio to double-blind treatment with once-daily Cal/BD foam (Cal 0.005%, BD 0.064%), Cal foam (0.005%), or
