Comparative study of calcipotriol (MC 903) ointment and betamethasone 17-valerate ointment in patients with psoriasis vulgaris.
BACKGROUND
Topical vitamin D analogues have been reported to be an effective treatment in patients with psoriasis. Comparative studies with existing treatments are required.


OBJECTIVE
Our purpose was to compare the effectiveness of calcipotriol (50 micrograms/gm) and betamethasone 17-valerate (1 mg/gm) ointments twice daily in the treatment of stable plaque psoriasis.


METHODS
This study was a randomized, double-blind comparison over 6 weeks in 409 patients. Efficacy, as measured by the Psoriasis Area and Severity Index (PASI), and safety were assessed at 2, 4, and 6 weeks.


RESULTS
Reduction of PASI was statistically significant at all time points for both treatments but there were no significant between-treatment differences. At the completion of 6 weeks of treatment, the mean PASI reduction was 5.50 for calcipotriol and 5.32 for betamethasone (95% confidence interval [CI] -0.40 to 0.78). Analysis of patient assessment at 6 weeks showed clearance or marked improvement in 61.2% of the calcipotriol patients and 50.5% with betamethasone (95% CI 1.4 to 20.8). Calcipotriol produced significantly more local side effects (19.5% compared with 3.9%, p less than 0.001); however, these were minimal leading to withdrawal in only 3 of 205 patients.


CONCLUSIONS
Calcipotriol ointment was as effective as betamethasone 17-valerate ointment as measured by the PASI and superior as measured by self-assessment in patients with stable plaque psoriasis. Both treatments were well tolerated.
Cunliffe
W J
WJ
Department of Dermatology, General Infirmary, Leeds, England.
Berth-Jones
J
J
Claudy
A
A
Fairiss
G
G
Goldin
D
D
Gratton
D
D
Henderson
C A
CA
Holden
C A
CA
Maddin
W S
WS
Ortonne
J P
JP
D001624:Betamethasone Valerate / Q000009:adverse effects / Q000627:therapeutic use*; D002117:Calcitriol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002170:Canada; D003879:Dermatologic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004361:Drug Tolerance; D005260:Female; D005602:France; D006801:Humans; D007494:Ireland; D008297:Male; D009824:Ointments; D010352:Patient Dropouts; D011565:Psoriasis / Q000188:drug therapy*; D006113:United Kingdom
D003879:Dermatologic Agents; D009824:Ointments; C055085:calcipotriene; D001624:Betamethasone Valerate; D002117:Calcitriol