Treatment of psoriasis vulgaris with the two-compound product calcipotriol/betamethasone dipropionate followed by different formulations of calcipotriol.
BACKGROUND
A calcipotriol (calcipotriene)/betamethasone dipropionate two-compound product has been shown to be efficacious for the treatment of psoriasis vulgaris. It is usually administered once daily for up to 4 weeks followed by treatment with corticosteroid-free conventional products (e.g. calcipotriol). The aim of this study was to evaluate the efficacy and tolerability of a 4-week treatment with the two-compound product in psoriasis vulgaris and the effects of sequential 8-week maintenance treatment with different calcipotriol formulations.


METHODS
After an initial 4-week phase with the once-daily calcipotriol/betamethasone dipropionate two-compound product, adult patients with stable psoriasis vulgaris entered an 8-week maintenance phase and were allocated to one of the following treatments: calcipotriol ointment twice daily, calcipotriol cream twice daily, or calcipotriol cream once daily in the morning and calcipotriol ointment once daily in the evening. Clinical assessment was performed at baseline, after 4 weeks and after 12 weeks, and employed evaluation of the severity of pruritus using a scale from zero to four and the Psoriasis Area and Severity Index (PASI).


RESULTS
After 4 weeks' treatment with the calcipotriol/betamethasone dipropionate two-compound product, a significant improvement in the severity of psoriasis was observed in all groups, with a mean reduction in the PASI of 71.3% (p < 0.001 vs baseline). A significant improvement in pruritus was also obtained after 4 weeks. These results were maintained after 8 weeks of treatment with calcipotriol, regardless of the formulation used. Treatment was very well tolerated and accepted by patients. On a scale ranging from poor to excellent, more patients treated with calcipotriol cream (49%) rated the acceptability of the treatment as excellent when compared with patients treated with the calcipotriol ointment (33%) or both calcipotriol formulations (36%).


CONCLUSIONS
This study shows that the calcipotriol/betamethasone dipropionate two-compound product causes a rapid and marked improvement in both psoriasis lesions and pruritus. Our preliminary results suggest that the three calcipo- triol-based regimens are equally effective in maintaining the therapeutic results obtained with the calcipotriol/betamethasone dipropionate two-compound product and that the use of calcipotriol cream was the best accepted maintenance treatment.
Cassano
Nicoletta
N
Department of Internal Medicine, 2nd Dermatology Clinic, Immunology and Infectious Diseases, University of Bari, Bari, Italy.
Miracapillo
Antonio
A
Coviello
Carmela
C
Loconsole
Francesco
F
Bellino
Marco
M
Vena
Gino Antonio
GA
D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D001623:Betamethasone / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002117:Calcitriol / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003879:Dermatologic Agents / Q000627:therapeutic use; D004334:Drug Administration Schedule; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance / Q000706:statistics & numerical data; D010352:Patient Dropouts / Q000706:statistics & numerical data; D010865:Pilot Projects; D011537:Pruritus / Q000188:drug therapy / Q000473:pathology; D011565:Psoriasis / Q000188:drug therapy* / Q000473:pathology; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
D000893:Anti-Inflammatory Agents; D003879:Dermatologic Agents; D004338:Drug Combinations; C055085:calcipotriene; C011175:betamethasone-17,21-dipropionate; D001623:Betamethasone; D002117:Calcitriol