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Quality of life in patients with scalp psoriasis treated with calcipotriol/betamethasone dipropionate scalp formulation: a randomized controlled trial
Author(s) -
Ortonne JP,
Ganslandt C,
Tan J,
Nordin P,
Kragballe K,
Segaert S
Publication year - 2009
Publication title -
journal of the european academy of dermatology and venereology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.655
H-Index - 107
eISSN - 1468-3083
pISSN - 0926-9959
DOI - 10.1111/j.1468-3083.2009.03221.x
Subject(s) - calcipotriol , scalp , medicine , betamethasone dipropionate , betamethasone , psoriasis , dermatology , quality of life (healthcare) , randomized controlled trial , surgery , nursing
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 µg/g plus betamethasone 0.5 mg/g as dipropionate; Xamiol ® , LEO Pharma A/S, Ballerup, Denmark) with twice‐daily calcipotriol scalp solution (50 µg/mL; Daivonex ® , LEO Pharma A/S) in patients with scalp psoriasis of at least moderate severity covering ≥ 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. Conflict of interest declaration J.P. Ortonne has served as a paid speaker and consultant for LEO Pharma. C. Ganslandt is a salaried employee of LEO Pharma. J. Tan served as a speaker, investigator and advisory board member for LEO Pharma and received honoraria from LEO Pharma for these activities. P. Nordin served as a paid investigator for LEO Pharma in the clinical trial. K. Kragballe has served as a paid speaker and consultant for LEO Pharma. S. Segaert has served as a paid speaker, clinical investigator and consultant for LEO Pharma.