Absorption and Efficacy of Miconazole Nitrate 0.25% Ointment in Infants with Diaper Dermatitis
May 2007 | Volume 6 | Issue 5 | Original Article | 522 | Copyright © May 2007
Lawrence F. Eichenfield MD, Melissa L. Bogen ELS
Background: The potential for toxicity from systemic absorption of topical miconazole in infants is a concern.
Objective: To assess the relative safety of 0.25% miconazole based on the amount absorbed through the skin of infants
with diaper dermatitis after multiple applications.
Methods: Of 24 infants with moderate to severe diaper dermatitis, 19 received 0.25% miconazole nitrate ointment and
5 received 2% miconazole nitrate cream for 7 days at each diaper change and after bathing. Blood samples were collected
prior to treatment and after 7 days.
Results: In the 0.25% treatment group, blood concentrations of miconazole were nondetectable (<1 ng/mL) in 83%
(15/18) and minimal (3.0 to 3.8 ng/mL) in 17% (3/18). Samples were missing for one patient. For the 5 infants in the
2% treatment group, miconazole concentration was nondetectable in 20% (1/5) and less than 7.4 ng/mL in 4 infants.
No adverse events were noted.
Conclusions: Systemic absorption of 0.25% miconazole nitrate ointment was minimal, demonstrating its safety in the treatment
of moderate to severe diaper dermatitis.