CALCIPOTRIOL IN PSORIASIS-VULGARIS - A CONTROLLED TRIAL COMPARING BETAMETHASONE DIPROPIONATE PLUS SALICYLIC-ACID

Patients with psoriasis were treated with calcipotriol ointment, 50 mu g/g, or betamethasone dipropionate + salicylic acid, applied twice da ily, for 6 weeks. At the end of the trial patients took no treatment f or a 1-month follow-up period. Extension of the psoriatic lesion, usin g a seven-point semiquantitative scale (0, no lesion; 1, lesions invol ving less than 10% of the body surface; 2, 10%-30%; 3, 30%-50%; 4, 50% -70%; 5, 70%-90%; 6, 90%-100%), and severity of the erythema, infiltra tion, and exfoliation, using a four-point scale (0, no skin involvemen t; 3, maximal), were assessed at baseline and at the fortnightly check -ups. The scores were then employed to calculate a PASI score.(1) The dermatologist finally expressed his judgment on the efficacy of treatm ent, using a five-point scale (-1, worsening; 3, healing). Similarly, patients were asked to express an opinion on the acceptability of trea tment, using a five-point scale (1, nil; 5, excellent). At baseline an d at the second and sixth weeks of treatment, routine laboratory tests were carried out. Patients could decide to stop the trial for healing , adverse reactions, or failure. Failure was defined as no change or w orsening of baseline conditions. All patients gave their witnessed con sent to take part in the trial, which was conducted following the cond itions set down in the Declaration of Helsinki. Statistical analysis w as carried out using Student's t-test for independent data to check in itial homogeneity and, when appropriate, using the ratings of efficacy , t-test for paired data, Friedman's test, and the chi-squared test. P atients were eligible if they were over 18 years of age, of either sex , with mild, stable psoriasis, and had not used topical for this disea se in the 2 weeks prior to the trial or systemic therapies in the 2 mo nths prior to the trial. Patients with psoriasis affecting only the fa ce, scalp, and genitals were not admitted. Also excluded were pregnant or breastfeeding women, and patients requiring vitamin D-based therap ies (> 400 IU/day) or systemic steroids. Patients with hepatic or rena l failure were not eligible: A total of 160 patients were enrolled (10 9 men, 51 women), with a mean age 49.9 +/- 14.2 (standard deviation) y ears. Eighty patients (mean age 50.1 +/- 14.7 years) were randomly ass igned to treatment with calcipotriol (C), and 80 (mean age 49.7 +/- 13 .8 years) to betamethasone dipropionate + salicylic acid (BD+AS); the two groups were homogeneous. In the group with C, 20 patients stopped treatment before the completion of the trial, and in the group with BD +AS 17 stopped treatment. Ten patients treated with C and seven with B D+AS were healed early; respectively one and three cases were classifi ed as failures, and three and five were lost to follow-up. There were six cases of discontinuation because of intolerance or adverse reactio ns to C, and two because of intolerance or adverse reactions to BD+AS. By the end of the trial therapy lesions on the trunk had completely d isappeared in 17 patients (21.3%) treated with C and in 13 (16.3%) giv en BD+AS. Lesions on the arms disappeared in 17 (21.3%) and 12 (15.0%) patients respectively, and on the legs in 11 (13.8%) and eight (10.0% ). These reductions were significantly different from baseline (P < 0. 05, chi-squared test), although the differences between treatments wer e not significant for each area. Erythema of the trunk disappeared in 17 patients (21.3%) treated with C and in 14 (17.5%) given BD+AS. Redu ctions on the arms were recorded in 20 (25.0%) and 18 (16.3%) patients respectively. Neither drug had much effect on erythema of the legs; w hich did, however, finally regress completely in 16 patients (20.0%) g iven C and in 10 (12.5%) given BD+AS. Skin infiltration on the trunk d isappeared totally in 24 patients (30%) with both treatments; it disap peared on the arms of 44 patients (55.0%) given C and 45 (56.2%) of th ose given BD+AS; infiltration disappeared on the legs in 34 (42.5%) an d 29 (36.3%) patients respectively. Exfoliation on the trunk disappear ed in 39 patients (48.8%) given C and in 33 (41.3%) of those given BDAS; scales on the arms were healed in 49 and 44 patients (61.3% and 55 .0%), respectively, and on the legs in 19 and 30 (23.8% and 37.5%). At the end of the study the reductions in the scores of erythema, infilt ration, and exfoliation from baseline were significant (P < 0.01, Frie dman), but not between treatments (NS, chi-squared test). By 6 weeks o f treatment, PASI scores had dropped 66.8% and 60.8% respectively (P < 0.001 from baseline, Student's t-test for paired data, Fig. 1). Inves tigating dermatologists assessed 79% of patients in the group with C a s 'improved' or 'healed', and 89.4% of patients with BD+AS. Acceptabil ity was assessed as 'good' or 'excellent' by 83.8% of the patients tre ated with C, and by 76.3% of those given BD+AS. Of the 80 patients tre ated with C, 66 turned up for the visit 1 month after stopping treatme nt; and of the 80 given betamethasone, 64 turned up. In many cases imp rovement continued to the point of lesions disappearing in all the are as treated with both drugs, and somewhat more so in areas treated with C. Erythema, the symptom that took longest to show an improvement, di sappeared in many cases (Fig. 2). No significant changes were found in the main laboratory variables. Seven patients in the group treated wi th C complained of 11 local adverse reactions; burning sensation (2.5% ), itching at the site of application (3.8%), edema (1.2%), folliculit is (1.2%), erythema (3.8%), and dry skin (1.2%). In four cases treatme nt was stopped, and two of these were given a topical steroid and vase line as replacement therapy. No adverse reactions were reported in the group treated with BD+AS.