Source: Jpn J Clin Hematol  |  Posted 5 years ago

By Bruce Sylvester

SAN FRANCISCO, CA -- March 7, 2006 -- Analysis of results from four phase 3 clinical studies shows that a low concentration (0.25%) of miconazole nitrate in a zinc oxide/petrolatum ointment is well tolerated for the treatment of diaper dermatitis, with a safety profile similar to the vehicle control.

These findings were presented here on May 4[^]th[] in a poster presentation at the 64[^]th[] Annual Meeting of the American Academy of Dermatology (AAD).

The four clinical studies included in this analysis evaluated the efficacy and safety of a low concentration (0.25%) of miconazole nitrate in a zinc oxide/petrolatum ointment (MZP) for neonates and infants with diaper dermatitis (DD).

The trials had a double-blind, vehicle-controlled, randomized, parallel-group and multicenter design and were conducted in the United States, Latin America, and Australia. The safety population in these studies included neonates and infants up to 4 years of age who received study treatments.

From the subjects enrolled in all four studies, a total of 418 were treated with MZP, and 417 were treated with a zinc oxide/petrolatum vehicle control. Treatment was applied at every diaper change for 7 days in all studies.

Premature discontinuation was higher in the control group, and lack of efficacy/parental request was the most common reason given for discontinuation.

A pooled safety analysis of three trials with similar protocols involving a 7-day endpoint showed that the rate of adverse events was twice as high in the control group compared with the MZP group (24.9% vs. 9.9%, respectively). It also showed that the proportion of subjects with adverse events was similar in the two groups (19% vs. 22%, respectively) in one trial involving assessment at study day 14, 7 days after the end of treatment.

"No subject treated with 0.25% miconazole nitrate had a serious adverse event," the authors wrote in their abstract. They also noted that no subject treated with MZP discontinued treatment because of an adverse event, while three subjects in the control group withdrew. "The incidence of adverse events in the 0.25% miconazole nitrate ointment group was less than in the vehicle control group -- 14% versus 20% -- respectively," they added.

All adverse events were determined to have an "unlikely" relationship to the study medication or no relationship at all.

Diaper dermatitis is the most common dermatologic disorder of infancy, and infection with Candida albicans is often an associated condition.

On February 16, 2006, Barrier Therapeutics, Inc. announced that the United States Food and Drug Administration had approved miconazole nitrate 0.25%/zinc oxide 15%/white petrolatum 81.35%, marketed now as Vusion Ointment.

Vusion was specifically formulated for the treatment of diaper dermatitis complicated by candidiasis in infants 4 weeks and older. It is now the only prescription product approved for the treatment of this condition in the United States.

The study was supported by Barrier Therapeutics, Inc.

[Presentation title: Phase III Clinical Trials Confirm Safety Profile of Low-Dose Topical Miconazole Nitrate Ointment. Abstract P2516]