The FDA approved Vusion, a miconazole nitrate/zinc oxide/white petrolatum topical ointment for the adjunctive treatment of diaper dermatitis only when complicated by candidiasis (DDCC) in infants aged 4 weeks of age and older. Candidiasis must be determined by microscopic evidence of pseudohyphae and/or budding yeasts. Vusion is a product of Barrier Therapeutics. Prior to the approval of Vusion, common treatments for DDCC were limited to antifungal products, steroids, and combination products not specifically approved for the treatment of DDCC or for use in infants.
In clinical trials, statistically significant improvement was observed in infants with DDCC within 3 days of treatment with Vusion. The ointment is intended for short-term use only as part of a treatment regimen that includes measures directed at the underlying dermatitis.