Mr. Klaber et al., COMPARATIVE EFFECTS OF CALCIPOTRIOL SOLUTION (50-MU-G ML) AND BETAMETHASONE 17-VALERATE SOLUTION (1-MG/ML) IN THE TREATMENT OF SCALP PSORIASIS/, British journal of dermatology, 131(5), 1994, pp. 678-683
The efficacy, tolerability and safety of calcipotriol solution and bet
amethasone 17-valerate solution were compared in a multicentre, prospe
ctive, randomized, double-blind, parallel group study. Four hundred an
d seventy-four patients with scalp psoriasis were recruited from six E
uropean countries and Canada. Following a 2-week washout period, eithe
r calcipotriol solution (50 mu g/ml) or betamethasone 17-valerate solu
tion (1 mg/ml) was applied twice daily for 4 weeks. After this time, p
atients who required no further active treatment were observed for rel
apse. Retreatment with calcipotriol was offered to those patients who
relapsed, and who were originally in the calcipotriol-treated group. T
he two treatment groups were well matched at baseline. At the end of t
reatment, the proportion of patients who had 'cleared' or 'markedly im
proved' was statistically significantly greater in the betamethasone g
roup (75%) than in the calcipotriol group (58%) (P < 0.001) (95% confi
dence interval of difference 25.3 --> 8.6). The decrease in total sign
score (sum of scores for erythema, thickness and scaliness) at the en
d of treatment was also statistically significantly greater in the bet
amethasone group (61%) than the calcipotriol group (45%) (P < 0.001) (
95% confidence interval of difference 9.7 --> 23.1). Adverse events we
re reported by 87 patients in the calcipotriol group, and 31 patients
in the betamethasone group; the most common was lesional or perilesion
al irritation, which occurred significantly more frequently with calci
potriol (26%) than with betamethasone (8%) (P < 0.001). Fifteen patien
ts (6%) in the calcipotriol group and four (1%) in the betamethasone g
roup withdrew from the study because of adverse events or unacceptable
treatment response (P = 0.017). There was no statistically significan
t change in serum total calcium in either treatment group. There was n
o significant difference in the rate of relapse between the two treatm
ent groups. In the 69 calcipotriol-treated patients who relapsed, re-t
reatment with calcipotriol was effective and well tolerated. Calcipotr
iol solution was effective in treating mild to moderate scalp psoriasi
s. However, betamethasone solution was significantly more effective, a
nd was associated with statistically significantly less local irritati
on on the scalp and face.