Oral Terbinafine in the Treatment of Multi-Site Seborrheic Dermatitis: A Multicenter, Double-Blind Placebo-Controlled Study

Abstract

Seborrheic dermatitis (SD) is a common disorder for which no satisfactory curative treatment exists. Preliminary studies suggest that terbinafine may be effective. The efficacy and tolerability of oral terbinafine was evaluated in multi-site SD in a randomized, double-blind, placebo-controlled study. For this purpose, 174 adult patients with SD lesions involving >or=3 skin areas, each causing >or=2 moderate/severe symptoms according to a pre-defined clinical score, were classified according to the localization of lesions: patients with lesions predominantly involving non-exposed skin areas, such as scalp and hairline and sternum and/or interscapular area (Population A, n=83) or patients with lesions in exposed sites, mainly the face (Population B, n=91). Patients were randomized to oral terbinafine (250 mg/day ) (n=86) or matching placebo (n=88), each given for 6 weeks. Primary efficacy variable was the response rate, defined as >or=50% decrease in baseline total clinical score without rescue medication intake after 6 weeks of treatment. The main secondary assessments were: subject's global assessment of relief and proportion of patients satisfied with treatment. Recurrence rate was assessed in responder patients during a 4-week treatment-free period. In Population A the response rate after 6 weeks of treatment was significantly higher with terbinafine (70% vs 45.4%; p=0.03) and so was the proportion of patients who reported relief (75% vs 41%; p=0.007) and who were satisfied (66% vs 40%; p=0.02). No significant differences were recorded in Population B. Adverse events occurred in 11.5% of terbinafine patients and 8% of placebo patients. One patient discontinued treatment with terbinafine because of adverse events (mild tachycardia and insomnia). In conclusion, our results show that terbinafine is significantly more effective than placebo in reducing the severity of SD lesions in nonexposed sites. Clinical trials comparing terbinafine to standard treatment regimens in different types of patients with SD are warranted.