The impact of a two-compound product containing calcipotriol and betamethasone dipropionate (Daivobet/ Dovobet) on the quality of life in patients with psoriasis vulgaris: a randomized controlled trial.
BACKGROUND
Psoriasis is a common disease and may have a significant impact on patients' quality of life (QoL).


OBJECTIVE
To assess the impact on QoL of a new two-compound product (TCP) (Daivobet/Dovobet; LEO Pharma) which combines the topical vitamin D analogue calcipotriol (50 microg g(-1)) and the World Health Organization group III corticosteroid betamethasone dipropionate (0.5 mg g(-1)) in a single ointment vs. calcipotriol monotherapy using a placebo-controlled study design.


METHODS
The Psoriasis Disability Index and the EuroQoL 5D questionnaire and visual analogue scale (VAS) were used in this study, which enrolled 828 patients with psoriasis vulgaris for treatment lasting up to 4 weeks. These QoL instruments were completed by patients before and after treatment with the TCP of calcipotriol and betamethasone dipropionate used once or twice daily, calcipotriol alone twice daily and vehicle twice daily.


RESULTS
The TCP used once or twice daily and calcipotriol used twice daily were found to have statistically significant beneficial effects on patients' QoL over the course of treatment, and each was demonstrated to have a statistically significant benefit on QoL over vehicle. The TCP, applied once daily, was superior to calcipotriol twice daily in terms of reductions on the EuroQoL 5D questionnaire and VAS.


CONCLUSIONS
The results suggest that calcipotriol twice daily and the new TCP applied twice daily have a substantial effect on QoL. Once-daily application of the TCP is superior to calcipotriol twice daily terms of QoL, which reflects the superior efficacy of this combination and the advantage of once-daily application when compared with twice-daily application.
van de Kerkhof
P C M
PC
Department of Dermatology, University Hospital Nijmegen, PO Box 9101, 6500 HB Nijmegen, The Netherlands. p.vandekerkhof@derma.umcn.nl
D000203:Activities of Daily Living; D000328:Adult; D001623:Betamethasone / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D002117:Calcitriol / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D003879:Dermatologic Agents / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006305:Health Status Indicators; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011565:Psoriasis / Q000188:drug therapy* / Q000523:psychology / Q000534:rehabilitation; D011788:Quality of Life; D016896:Treatment Outcome
D003879:Dermatologic Agents; D004338:Drug Combinations; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol