Calcipotriol in psoriasis vulgaris: a controlled trial comparing betamethasone dipropionate + salicylic acid
Authors: Crosti Carlo , Finzi Aldo Fabrizio , Mian Eneo , Scarpa Carmelo 
Published: December 2004

Patients with psoriasis were treated with calcipotriol ointment, 50 ng/g, or betamethasone dipropionate + salicylic acid, applied twice daily, for 6 weeks. At the end of the trial patients took no treatment for a 1‐month follow‐up period. Extension of the psoriatic lesion, using a seven‐point semiquantitative scale (0, no lesion; 1, lesions involving 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, infiltration, and exfoliation, using a four‐point scale (0, no skin involvement; 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 treatment, using a five‐point scale (−1, worsening; 3, healing). Similarly, patients were asked to express an opinion on the acceptability of treatment, using a five‐point scale (1, nil; 5, excellent). At baseline and 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 worsening of baseline conditions. All patients gave their witnessed consent to take part in the trial, which was conducted following the conditions set down in the Declaration of Helsinki. Statistical analysis was carried out using Student's t‐test for independent data to check initial homogeneity and, when appropriate, using the ratings of efficacy, Mest for paired data, Friedman's test, and the chi‐squared test. Patients were eligible if they were over 18 years of age, of either sex, with mild, stable psoriasis, and had not used topical for this disease in the 2 weeks prior to the trial or systemic therapies in the 2 months prior to the trial. Patients with psoriasis affecting only the face, scalp, and genitals were not admitted. Also excluded were pregnant or breast‐feeding women, and patients requiring vitamin D‐based therapies (>400 lU/day) or systemic steroids. Patients with hepatic or renal failure were not eligible.

A total of 160 patients were enrolled (109 men, 51 women), with a mean age 49.9 ± 14.2 (standard cjeviation) years. Eighty patients (mean age 50.1 ± 14.7 years) were randomly assigned 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 BD+AS were healed early; respectively one and three cases were classified as failures, and three and five were lost to follow‐up. There were six cases of discontinuation because of intolerance or adverse reactions 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 disappeared in 17 patients (21,3%) treated with C and In 13 (16.3%) given 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 were 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. Reductions on the arms were recorded in 20 (25.0%) and 18 (16.3%) patients respectiveiy. Neither drug had much effect on erythema of the iegs; which did, however, finaiiy regress compieteiy in 16 patients (20.0%) given C and in 10 (12.5%) given BD+AS.

Skin infiitration on the trunk disappeared totaliy in 24 patients (30%) with both treatments; it disappeared on the arms of 44 patients (55.0%) given C and 45 (56.2%) of those given BD+AS; infiitration disappeared on the legs in 34 (42.5%) and 29 (36.3%) patients respectiveiy.

Exfoliation on the trunk disappeared in 39 patients (48.8%) given C and in 33 (41.3%) of those given BD+AS; scales on the arms were healed in 49 and 44 patients (61.3% and 55.0%), respectively, and on the iegs in 19 and 30 (23.8% and 37.5%). At the end of the study the reductions in the scores of erythema, infiltration, and exfoiiation from baseline were significant (P < 0.01, Friedman), but not between treatments (NS, chi‐squared test). By 6 weeks of treatment, PASI scores had dropped 66.8% and 60.8% respectively (P < 0.001 from baseline. Student's f‐test for paired data, Fig. 1).

Investigating dermatologists assessed 79% of patients in the group with C as ‘improved’ or ‘healed’, and 89.4% of patients with BD+AS. Acceptability was assessed as ‘good’ or ‘excellent’ by 83.8% of the patients treated with C, and by 76.3% of those given BD+AS. Of the 80 patients treated with C, 66 turned up for the visit 1 month after stopping treatment; and of the 80 given betamethasone, 64 turned up. in many cases improvement continued to the point of lesions disappearing in all the areas treated with both drugs, and somewhat more so in areas treated with C. Erythema, the symptom that took longest to show an improvement, disappeared in many cases (Fig. 2).

No significant changes were found in the main laboratory variabies. Seven patients in the group treated with C complained of 11 local adverse reactions; burning sensation (2.5%), itching at ths site of application (3.8%), edema (1.2%), folliculitis (1.2%), erythema (3.8%), and dry skin (1.2%).

In four cases treatment was stopped, and two of these were given a topical steroid and vaseline as replacement therapy. No adverse reactions were reported in the group treated with BD+AS.