Common use of prescription off-label acne therapy in children younger than 12 years old.

Acne is occurring more frequently in younger age groups, but most available treatments are considered off-label in young children. As the epidemiology of acne has changed to include younger children over the past 20 years, neither regulators, pharmaceutical companies, nor clinicians have understood the need or value of obtaining regulatory sanctions for problems physicians have managed using clinical judgment. The objective of this study was to analyze the frequency of off-label acne treatment according to age and other demographic factors. We searched the National Ambulatory Medical Care Survey from 1993 to 2010 for visits in children younger than 12 years of age for the diagnosis of International Classification of Diseases, Ninth Revision, code 706.1. We tabulated leading acne treatments and assessed factors associated with off-label prescribing. Off-label but appropriate acne treatments were used in 29% of acne visits for children younger than 12 years of age. Dermatologists were more likely than pediatricians to prescribe off-label treatment (p < 0.001). The most frequently used off-label treatments were topical retinoids, followed by oral antibiotics. There was no significant trend in the rate of off-label prescribing over time (p = 0.40). Off-label treatment is well within the standard of care for young children with acne. More data on the use of topical retinoids in young children will improve our understanding of their use, which may help optimize treatment outcomes for children with acne.