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 ::::3 skin areas, each causing ::::2 moderate/severe symptoms according to a pre-defined clinical score, were classified according to the localization oflesions: 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 :::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 oftreatment 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 terbinafme 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.Seborrheic dermatitis (SD) IS a common eczematous skin disorder that affects 1-3% of immunocompetent adults (1). There are still controversies over the pathogenesis of this inflammatory condition: both qualitative and quantitative abnormalities of sebum, as well as overgrowth of lipophilic yeasts of Malassezia genus (mainly Pityrosporum ova/e) and associated inflammatory reactions may play a role in the development of symptoms and signs of SD (2). Current treatment of SD is symptomatic rather than curative. It includes topical corticosteroids which can be used only for short periods of time because of the risk of side effects, such as skin atrophy and telangiectasias. More recently, antifungal agents have been introduced (1,3).Terbinafine is an allylamine antimycotic agent that has been proposed for the treatment of SD.

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

“…Only a continuous regimen of ketoconazole has been reported for SD, which led to a high rate of clinical improvement and/or cure but has been associated with frequent adverse events [9,10]. Both pulse and continuous regimens for terbinafine were associated with clinical improvement [11][12][13]. The newer triazole pramiconazole has the lowest number of publications and it is still in development [14], but itraconazole is the most frequently reported oral treatment for SD [5].…”

Comparison the Efficacy of Fluconazole and Terbinafine in Patients with Moderate to Severe Seborrheic Dermatitis

“…There are few studies regarding comparison of efficacy of systemic antifungal agents in seborrheic dermatitis. However different studies emphasize that one-month systemic therapy could delay recurrence and resolving persistent disease [5–8, 10]. It's better to point that we prescribed fluconazole with higher dose to reach the optimal minimal inhibitory concentration (MIC) [11].…”

Seborrheic Dermatitis

“…In a randomized, double-blind, placebo-controlled study (n = 174) in patients with lesions in nonexposed sites and in patients with lesions in exposed skin areas, oral terbinafine (250 mg/day) or a placebo were each administered for 6 weeks [62]. In patients with lesions in nonexposed sites, the response rate was significantly higher with terbinafine (70% vs 45.4%; P = 0.03).…”