A Pilot Study on Seborrheic Dermatitis Using Pramiconazole as a Potent Oral Anti-<i>Malassezia</i> Agent

Abstract

Background: Seborrheic dermatitis is considered to be a Malassezia-driven disease. Little objective information is available so far from biometrological quantitative assessments of this skin condition. Pramiconazole is a novel triazole with potent in vitro antifungal activity, especially against Malassezia spp. Objective: To study the sequential effects of pramiconazole on Malassezia, inflammation and epidermal changes. Method:This study was performed in 2 groups of subjects suffering from seborrheic dermatitis. The first group (n = 17) remained untreated and was used as control. Clinical, mycological and biometrological assessments were performed at inclusion and during the following 2 weeks. The second group of subjects (n = 10) received a single 200-mg oral dose of pramiconazole at inclusion. Clinical, mycological and biometrological evaluations were performed before and during 1 month following the single antifungal intake. For both parts of the study, several parameters were assessed including yeast density, desquamation, erythema, itching and sebum excretion. Results: In the control group, no significant changes were observed in any of the parameters during the observation period. The findings were markedly different in the pramiconazole-treated subjects. The yeast density was significantly improved on days 3, 7 and 28. Desquamation, erythema, itching, and the global clinical evaluation as assessed by the patients and investigators became significantly improved on days 7 and 28. A trend in decrease of scaliness was noted. No effect on sebum excretion was evidenced. In conclusion, a single 200-mg dose of pramiconazole exhibitsin vivo efficacy in controlling some important clinical aspects of seborrheic dermatitis. Following a reduction in the number of yeasts on day 3, a decrease in the severity of clinical signs and symptoms occurred from day 7 onwards. Sebum excretion appeared uninvolved in the clearing process of seborrheic dermatitis. Conclusion: A single 200-mg dose of pramiconazole appears to abate seborrheic dermatitis. The density in Malassezia present on lesional skin is first decreased, followed by clearing of the clinical signs.

A Comprehensive Pathophysiology of Dandruff and Seborrheic Dermatitis – Towards a More Precise Definition of Scalp Health

“…An empirical piece of support for their pathogenicity is that known therapeutic materials are chemically diverse but have in common the property of potent anti-fungal activity (10). Also, it is generally accepted that effective therapies reduce the Malassezia load from the pretreatment level and that re-colonization of Malassezia post-treatment results in reoccurrence of the condition (11)(12)(13)(14)(15). A potential etiopathological mechanism (16) involves the lipolytic release of the fatty acid moieties from the parent sebaceous triglycérides by Upase activity originating from secreted Malassezia Upases (17); free fatty acids, especially unsaturated ones, can induce the inflammation and hyperproliferation (16) known to be components of D/SD leading to the commonly observed signs and symptoms associated with the conditions.…”

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

“…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]. The most commonly reported dosing regimen for itraconazole is a pulse regimen generally associated with an excellent therapeutic and safety profile in the treatment of moderate to severe SD [6,15,16,18].…”

Role of Topical Calcineurin Inhibitors in the Treatment of Seborrheic Dermatitis

“…[25] While hepatotoxicity limits the use of ketoconazole, preliminary studies have indicated that both itraconazole and terbinafine are associated with fewer potential adverse effects. [5] In a recent pilot study, Pie´rard et al [14] found that a single 200-mg oral dose of pramiconazole decreased both the clinical symptoms of SD and the density of Malassezia colonies in lesional skin of ten patients with SD, while the control group (n = 17) experienced no change in their disease state. Conversely, oral fluconazole was recently found to have a marginal, but not statistically significant, effect in a placebo-controlled study of 50 patients with SD.…”

“…The theory of the role of Malassezia in the pathogenesis of SD is strongly supported by the efficacy of antifungals in the treatment of the condition, the reduction in the number of Malassezia organisms after treatment, and studies showing that recolonization of Malassezia results in disease recurrence. [13] In a controlled study of 27 patients with SD, Pie´rard et al [14] found that treatment with pramiconazole first caused a decrease in the number of Malassezia colonies, which was followed by an improvement in the clinical signs of the disease.…”