Cyclosporin in atopic dermatitis: a multicentre placebo-controlled study.

The efficacy of cyclosporin (Sandimmun) given in a daily dose of 5 mg/kg for 6 weeks in severe atopic dermatitis was confirmed in this double-blind, placebo-controlled, short-term study. Of the 46 patients included in the study, 23 were randomized to receive cyclosporin and 23 to receive placebo. Four of the 23 patients (17%) on cyclosporin, and 14 of the 23 patients (61%) who received placebo, discontinued the trial because of inefficacy. All patients who discontinued the trial were assessed following the principle of 'intention to treat'. Compared with the baseline, the mean scores for disease severity [6-area, total body severity assessment (TBSA)] improved by 55%, and the mean scores for extent of disease [rule-of-nines area assessment (RoNAA)] improved by 40%, in patients treated with cyclosporin. Nine of the patients who received cyclosporin and completed the study (n = 14) had an individual reduction of disease severity (TBSA) of 75% or more, and in three patients this reduction was nearly 100%. In the placebo group, a mean worsening of disease severity (4%) and of extent of the disease (25%), compared with the baseline, was observed at week 6. Patients' and investigators' mean scores for the overall efficacy were similar, and showed a statistically significant difference in favour of cyclosporin. Two patients on cyclosporin developed hypertension during therapy, and one of these withdrew from the study. At the end of the trial, no statistically significant differences in the systolic or diastolic blood pressures were observed between the two groups. In the cyclosporin group, the increases in the values of serum creatinine and bilirubin at week 6, compared with the respective values at the baseline, were statistically significantly different from those in the placebo group, but all values normalized in the post-treatment period. Cyclosporin can be a safe and very effective treatment in episodes of severe atopic dermatitis, provided that the recommended guidelines for its administration are strictly observed.

RCT Entities:   Population Interventions Outcomes