Efficacy, safety and quality of life of calcipotriol/betamethasone dipropionate (Dovobet) versus calcipotriol (Daivonex) in the treatment of psoriasis vulgaris: a randomized, multicentre, clinical trial.
OBJECTIVE
A clinical trial was performed to evaluate the efficacy, speed of response, side effects and quality of life of patients treated with calcipotriol/betamethasone dipropionate (Dovobet) for 4 weeks followed by maintenance with calcipotriol for 8 weeks (group A) versus calcipotriol (Daivonex) alone for 12 weeks (group B) for the treatment of psoriasis.


METHODS
A total of 150 patients were enrolled and randomized to groups A and B. PASI and Skindex-29 were considered the outcome measures.


RESULTS
Ninety-six patients completed the trial. At weeks 2 and 4, both groups showed a significant clinical improvement compared to baseline; group A demonstrated a higher clinical response compared with group B (p< 0.001). Treatment with calcipotriol was associated with a gradual improvement in group B and maintenance of the results in group A. Similarly, the quality of life assessment showed a marked improvement in terms of Skindex-29 in both groups at weeks 2 and 4 compared to baseline. Both treatments were safe and well tolerated.


CONCLUSIONS
Our results demonstrate a higher efficacy and more rapid onset of action with the two-compound ointment compared with calcipotriol cream alone in short-term treatment. However, sequential application of calcipotriol allows maintenance of the results.
Saraceno
Rosita
R
Department of Dermatology, University of Rome Tor Vergata, Viale Oxford 81, Rome, Italy. rositasaraceno@yahoo.it
Andreassi
Lucio
L
Ayala
Fablo
F
Bongiorno
Maria Rita
MR
Giannetti
Alberto
A
Lisi
Paolo
P
Martini
Patrizia
P
Peris
Ketty
K
Peserico
Andrea
A
Chimenti
Sergio
S
D000279:Administration, Cutaneous; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; 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; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011565:Psoriasis / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome
D003879:Dermatologic Agents; D004338:Drug Combinations; C517164:betamethasone dipropionate, calcipotriol drug combination; C055085:calcipotriene; D001623:Betamethasone; D002117:Calcitriol