Diaper dermatitis denied! FDA approves treatment ointment

March 14, 2006

The FDA recently approved Vusion, an ointment specifically formulated for the treatment of diaper dermatitis complicated by Candida in infants 4 weeks and older. Manufactured by Barrier Therapeutics, Vusion is, according to Barrier, the only prescription product approved for the treatment of diaper rash in the US.

The FDA recently approved Vusion, an ointment specifically formulated for the treatment of diaper dermatitis complicated by Candida in infants 4 weeks and older. Manufactured by Barrier Therapeutics, Vusion is, according to Barrier, the only prescription product approved for the treatment of diaper rash in the US.

It is estimated that, first, diaper dermatitis is the complaint in approximately one million pediatric outpatient visits annually in the US and, second, that more than 40% of cases of diaper dermatitis treated by a physician are complicated by Candida.

Vusion is a steroid-free formulation of miconazole nitrate at a concentration of 0.25%, which directly treats the infection. The ointment base comprises zinc oxide and white petrolatum.

In clinical trials, statistically significant improvement was observed in infants with diaper dermatitis complicated by Candida within three days of treatment with Vusion. Common treatment options for this condition have included antifungals, steroids, and combination products not specifically approved for this indication or for use of infants.