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Few studies have addressed the pathophysiology or treatment of seborrheic dermatitis in infants. Also known as "cradle cap," the condition is common and self-limited, but is a frequent source of parental anxiety. Within the past 10 years, immunologic response to Pityrosporum ovale has been implicated as the cause of seborrheic dermatitis in infants and children. Newer forms of treatment are aimed at controlling Pityrosporum colonization. These investigators conducted a manufacturer-sponsored phase I study of ketoconazole shampoo for the treatment of infantile seborrheic dermatitis. The study was mandated by the U.S. FDA to evaluate short-term safety before a larger trial of long-term safety and efficacy can be initiated.
Thirteen infants wit…