SAFETY AND EFFICACY OF CALCIPOTRIOL OINTMENT (DOVONEX(R)) TREATING CHILDREN WITH PSORIASIS-VULGARIS

Calcipotriol (Dovonex) ointment has been shown to be an effective, wel l tolerated, and acceptable treatment for psoriasis vulgaris in adults . This open study was conducted in 16 U.K. centres to assess the safet y and efficacy of calcipotriol ointment in treating psoriasis vulgaris in children. Following a 2-week washout, patients were treated with c alcipotriol ointment, 50 mu g/g twice daily, for up to 8 weeks. A bloo d sample was taken on entry and a second 'on treatment' sample was tak en after either 2 or 8 weeks treatment. Sixty-six children (26 boys, 4 0 girls, age range from 3 to 14 years entered and 58 completed the stu dy, There was a statistically significant reduction in the mean (+/-SD ) Psoriasis Area and Severity Index (PASI) from 6.1 +/- 3.5 at the sta rt of treatment to 2.7 +/- 1.9 at the end of treatment (P < 0.001), Ma rked improvement or clearance of psoriasis at the end of treatment occ urred in 65% of patients as assessed by the investigator and 62% as as sessed by the patient. Cosmetic acceptability of calcipotriol ointment was found to be good or excellent in 79% of patients. Eight patients withdrew from the study (four defaulted, two unacceptable responses, t wo adverse events). Adverse events were reported by 16 patients; the m ost common being local irritation (seven patients). There was no signi ficant change in the mean serum ionized calcium from baseline to 2 or 8 weeks treatment, Similarly, there were no consistent or clinically i mportant changes in haematological, or other biochemical parameters, m easured during the study period, Calcipotriol ointment has been shown to be an effective, well tolerated, and acceptable treatment for psori asis vulgaris in children.