An Open-label Study of the Safety and Efficacy of Sertaconazole Nitrate in the Treatment of Seborrheic Dermatitis
August 2011 | Volume 10 | Issue 8 | Original Article | 895 | Copyright © August 2011
Boni E. Elewski MD and Wendy C. Cantrell CRNP
To demonstrate the efficacy and evaluate the safety of sertaconazole nitrate cream 2% in the treatment of seborrheic dermatitis (SD).
Single-center, open-label study.
One academic medical center.
Twenty adult male and female subjects aged 22 to 85 years (average, 56 years) with mild-to-severe seborrheic dermatitis of the face.
The primary efficacy evaluation was the proportion of subjects with a score of 0 or 1 at the end of treatment (week 4) on the Investigator's Static Global Assessment scale. Secondary end points included percent change from baseline to week 4 in sum individual scores of erythema, scaling, induration, and pruritus at a preselected target lesion. Other end points included change in scores on Subject's Global Assessment scale and the Dermatology Life Quality Index.
Success on the primary end point was achieved by 10 of 17 evaluable subjects (58.8%). Improvements in Investigator's Static Global Assessment score from baseline were statistically significant at each week. Significant improvements were also demonstrated in erythema, scaling, induration, and pruritus at week 4 compared to baseline. Improvement in Subject's Global Assessment scores compared to baseline were significant only at week 1 (P=0.031). Change in total mean SD Dermatology Life Quality Index scores from baseline to week 4 was 0.34 (± 0.62, P=0.039).
The results of this preliminary study support the efficacy and safety of sertaconazole nitrate cream, 2%, for the treatment of seborrheic dermatitis.
J Drugs Dermatol.
Seborrheic dermatitis (SD) is a common recurrent skin disorder characterized by erythema and scaling, with occasional papule and plaque formation and variable pruritus. The plaques of SD often appear red, flaky, and greasy-looking. Commonly affected areas include regions of the head and trunk where sebaceous glands are prevalent, including the scalp, nasolabial folds, eyebrows,
and ears.1 Estimates of the prevalence of the disease in the general population range from 1% to 3%, with higher rates in early childhood, late life, and immunocompromised individuals,
such as those with HIV/AIDS.2-6
The diagnosis of SD is predominantly clinical. A history of waxing
and waning severity and the pattern of skin involvement help differentiate SD from psoriasis and common dermatoses.7 Fungal culture may be helpful to rule out tinea capitis, but species of the yeast genus Malassezia, thought to contribute to the etiology of SD, are part of the normal skin flora, and their identification on culture does not necessarily contribute to diagnosis.7-8 Evidence suggests that species of Malassezia contribute to the pathogenesis
of the disease in conjunction with environmental and genetic factors and co-morbid conditions.6,7,9 Indeed, the disease responds to treatment with antifungal agents, further suggesting a role for yeast in its etiology and pathogenesis.7
The central goal of the treatment of SD is to improve symptoms; no cure currently exists.7 Options for pharmacologic treatment include topical or systemic antifungal agents, mild topical corticosteroids,
immunomodulators and medicated shampoos, either alone or in combination.6 Topical corticosteroids have been shown