Efficacy of Oral Itraconazole in the Treatment and Relapse Prevention of Moderate to Severe Seborrheic Dermatitis: A Randomized, Placebo-Controlled Trial.

Background: Seborrheic dermatitis (SD) is a chronic and relapsing disease and topical therapy may be associated with failure, particularly in severe disease. Itraconazole has been suggested as an effective treatment for severe SD. Previous studies have been open clinical trials with variable results.

Objective: The aim of this study was to determine the efficacy of oral itraconazole in the treatment of patients with moderate to severe SD.

Methods: Sixty-eight patients with moderate to severe SD were randomly assigned to the itraconazole (n = 35) or placebo (n = 33) groups. The trial was undertaken in Razi Hospital, Tehran. An internet-generated table was used to allocate treatments. Patients and investigator were blinded to treatments. Itraconazole 200 mg/daily or placebo was prescribed for 1 week and then for the first 2 days of every month for the following 3 months. Patients were followed for 4 months and the Seborrheic Dermatitis Area Severity Index (SDASI) was measured on nine anatomical sites. Fifty-seven patients (29 in the itraconazole group and 28 in the placebo group) completed the study.

Results: Statistically significant improvement was observed in SDASI of both itraconazole and placebo groups (p = 0.000) but the itraconazole group showed significantly higher efficacy compared with placebo (p = 0.023). We observed clinical improvements of 93.8, 87.5, and 93.1% at the end of 2 weeks, 1 month, and 4 months, respectively, in the itraconazole group, and 82.1, 64.3, and 53.6% in the placebo group. Furthermore, recurrence rate in the itraconazole group was significantly lower than in the placebo group (p = 0.003). No blood test abnormality was seen in any patient.

Conclusion: Itraconazole is not only an effective and safe therapy for controlling exacerbations of SD but may also be used as maintenance therapy to prevent disease recurrence.