A new calcipotriol/betamethasone formulation with rapid onset of action was superior to monotherapy with betamethasone dipropionate or calcipotriol in psoriasis vulgaris.
In this study, we compared a new combination ointment containing both calcipotriol and betamethasone dipropionate with betamethasone dipropionate ointment (Diprosone) and calcipotriol ointment (Daivonex) in patients with psoriasis vulgaris; 1106 patients were randomized to twice daily double-blind treatment with combination, betamethasone dipropionate or calcipotriol for 4 weeks. Patients then received twice daily calcipotriol, unblinded, for a further 4 weeks. Mean percentage change in PASI at end of the double-blind phase was -74.4 (combination group), -61.3 (betamethasone group) and -55.3 (calcipotriol group). Mean difference (95% Cl) combination-betamethasone was -13.1 (-16.9 to -9.3, p < 0.001) and for combination-calcipotriol -19.0 (-22.8 to -15.2, p <0.001). The differences in PASI were also statistically significant after 1 week. In the double-blind phase, 8.1% of patients (combination) reported lesional/ perilesional adverse reactions compared to 4.7% (betamethasone) and 12.0% (calcipotriol). In the combination group, mean PASI at the end of the double-blind phase was 2.5, and at end of the unblinded phase 3.6, compared with 3.9 and 4.1 (betamethasone) and 4.4 and 3.7 (calcipotriol). Calcipotriol/betamethasone combination is more effective and has a more rapid onset of action than either active constituent used alone, and is well tolerated. It is safe to transfer patients from combination to calcipotriol, with maintenance of clinical effect.
Douglas
W S
WS
Department of Dermatology, Monklands Hospital, Lanarkshire, Scotland, UK.
Poulin
Y
Y
Decroix
J
J
Ortonne
J P
JP
Mrowietz
U
U
Gulliver
W
W
Krogstad
A L
AL
Larsen
F G
FG
Iglesias
L
L
Buckley
C
C
Bibby
A J
AJ
D000287:Administration, Topical; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001623:Betamethasone / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D002117:Calcitriol / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011565:Psoriasis / Q000188:drug therapy*
D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; D005938:Glucocorticoids; D009824:Ointments; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol