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.
Further investigations are recommended on the prevalence of isothiazolinone-induced allergic contact dermatitis and the allergenic potential of co-polymers/cross-polymers.
We conducted a prospective open study of immediate- and delayed-type contact hypersensitivity to food and other allergens in 33 children with atopic dermatitis (AD). The design of the study was exploratory and not randomized. Various methods for detecting immediate-type hypersensitivity were compared. Thirty-three children age 5 to 15 years with persistent AD were initially enrolled, but 3 dropped out. Nine patients had positive reactions to foods in the patch-scratch test, four had positive reactions in the skin application food test, and five had positive reactions to foods in the prick tests. Positive reactions to foods were observed in only three patients on the delayed-type patch tests. In all tests, but especially the patch-scratch and prick tests, positive reactions to food allergens were observed without clinically related symptoms. None of these tests gave ideal results. Twenty (67%) of the 30 children had positive reactions to inhalants in prick testing. Fourteen showed positive patch-test reactions with the European standard series (True Test). The most positive reactions were to nickel (9 patients), cobalt, and balsam of Peru. Restrictive measures led to evident improvement of AD only in some children. The results of this study illustrate that food allergy plays only a limited role in patients with AD age 5 to 15 years. We could not conclude which of the tests would predict which children might benefit from dietary manipulation.
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