Quality of life in patients with scalp psoriasis treated with calcipotriol/betamethasone dipropionate scalp formulation: a randomized controlled trial.

摘要

BACKGROUND: Psoriasis vulgaris of the scalp has a significant psychosocial impact on individuals affecting their quality of life (QoL). A combination of calcipotriol and betamethasone dipropionate in a formulation suitable for treatment of scalp psoriasis has been developed. OBJECTIVE: To assess the impact of treatment with either calcipotriol plus betamethasone dipropionate scalp formulation or calcipotriol scalp solution on QoL in patients with scalp psoriasis (both within and between treatment groups). METHODS: This 8-week, randomized, investigator-blind study, compared the once-daily, two-compound scalp formulation (calcipotriol 50 microg/g plus betamethasone 0.5 mg/g as dipropionate; Xamiol, LEO Pharma A/S, Ballerup, Denmark) with twice-daily calcipotriol scalp solution (50 microg/mL; Daivonex, LEO Pharma A/S) in patients with scalp psoriasis of at least moderate severity covering > or = 10% of the scalp. QoL was assessed (weeks 0, 2, 4, 8) using the 36-item Short Form Health Survey (version 2; SF-36v2) and Skindex-16. RESULTS: Treatment with the two-compound scalp formulation (n = 207) resulted in significant improvements from baseline on the SF-36v2 (Physical Component Summary, P = 0.005, week 8; Mental Component Summary, P < 0.05, weeks 2, 4, 8). A significant change from baseline in the calcipotriol scalp solution group (n = 105) was seen only on the Mental Component Summary (P = 0.04, week 8). Change from baseline in Skindex-16 was significantly in favour of the two-compound scalp formulation. Change was significant on both total score and individual scales. CONCLUSION: The two-compound scalp formulation was superior to calcipotriol scalp solution in improving QoL in patients with scalp psoriasis.