Background: Seborrhoeic dermatitis is an inflammatory cutaneous disorder in which the colonization of the affected area by Malassezia has been proved to play a key role.
Objective: To perform a noncomparative open clinical study with oral itraconazole capsule (200 mg/day x 7 days) and consecutive usage 200 mg/day for the first 2 days of the following 2 months in patients with seborrhoeic dermatitis.
Methods: Twenty-nine patients were enrolled to determine the efficacy and safety of oral itraconazole. The patients were evaluated according to itching, burning, erythema, desquamation and seborrhoea, each scored on a 0-4 scale on days 15 (T15), 30 (T30), 60 (T 60) and 90 (T90). Itraconazole capsule 100 mg was given twice a day for 1 week and then, after a 3-week interval, patients used itraconazole capsule 200 mg/day for the first 2 days of the following 2 months. The clinical response was graded as markedly effective, effective, moderate or ineffective.
Results: A clinical improvement (evaluated as markedly effective or effective) was observed in 23 patients (83%) at T15, 21 (76%) at T30, 20 (72%) at T60 and 17 (61%) at T90. At baseline, the mean +/- SD total clinical scores were 10.44 +/- 2.45, 1.98 +/- 0.5, 2.97 +/- 1.12, 3.15 +/- 1.74 and 3.30 +/- 1.90 at T0, T15, T30, T60 and T90, respectively. Compared with baseline values, itraconazole capsule significantly reduced the mean +/- SD total score as well as individual erythema and desquamation (Wilcoxon's signed test-two tailed) (P < 0.0001). No drug-related systemic adverse event was observed during the study.
Conclusions: Seborrhoeic dermatitis shows marked reduction in inflammation when treated with itraconazole. The anti-inflammatory activity of oral itraconazole and efficacy on Malessezia suggests that itraconazole capsule will be first oral treatment option in future in severe seborrhoeic dermatitis.