Absorption and efficacy of miconazole nitrate 0.25% ointment in infants with diaper dermatitis

Journal of Drugs in Dermatology, May, 2007 by Lawrence F. Eichenfield, Melissa L. Bogen

Clinical evaluations of the diaper rash (if present) continued on treatment days 1, 3, 5, and 7. On day 7, another physical examination was conducted and another blood sample was drawn for analysis.

Efficacy Outcome Measures

The primary outcome measures were the evaluation of miconazole absorption and the clinical evaluation. The patients' clinical response to therapy was indicated by the rash evaluation score obtained on treatment days 0, 1, 3, 5, and 7.

Safety Outcome Measures

Any adverse events were assessed and recorded on days 1, 3, 5, and 7. Adverse events were defined as any unwanted signs or symptoms that might have in any way been related to the drug.

Participants were to be withdrawn from the study if adverse reactions developed or the parent or legal guardian wished to withdraw the patient from the study. If participants were withdrawn or if the study medication was prematurely discontinued, the reasons for discontinuation were recorded.

Statistical Analysis

Descriptive statistics were used to analyze the data. Parametric and nonparametric procedures were used as appropriate. Safety parameters were monitored during the study. All participants were assessed for drug safety.

Patients who were treated with miconazole nitrate for less than 7 days were considered not evaluable, as were patients who were treated with antifungal or corticosteroid products during the study.

Results

Subject Disposition

A total of 24 infants (12 male and 12 female) were enrolled in the study, and all 24 completed the study. Nineteen infants (9 male and 10 female) received 0.25% miconazole nitrate ointment, and 5 infants (3 male and 2 female) received 2% miconazole nitrate cream. Blood samples were missing for one patient in the 0.25% miconazole nitrate group.

At baseline, the severity of the diaper rash for half the subjects (n=12) was rated as moderate erythema with or without satellite papules with maceration and chafing (rash score of 2). One fourth of the infants (n=6) had severe erythema with papulopustules and maceration (rash score of 3) and one fourth of the infants (n=6) had severe erythema with erosions or ulceration (rash score of 4). At baseline, no significant differences were noted in the demographics and patient characteristics between treatment groups (Table 1).

Demographics and Presenting Conditions

Infants had initially been admitted to the hospital for treatment of gastrointestinal conditions and all had diaper dermatitis secondary to systemic pathology. The most common additional diagnoses on enrollment included diarrhea (n=9), intestinal symptoms including amoebic dysentery and acute viral gastroenteritis (n=7), dehydration (n=7), or malnutrition (n=3). Some infants had multiple diagnoses.

Concurrent Medication

On enrollment into the study, 75% (n=18) of the infants were taking concurrent medications. Some patients were taking multiple medications. Almost all of these medications were antimicrobial and antiparasitic agents, including trimethoprim-sulfamethoxazole (n=4), gentamicin (n=3), penicillin drugs (n=8), cefotaxime (n=2), and metronidazole (n=2). Soy flour and kaolin-pectin, an antidiarrheal agent, were also frequently prescribed. Vioform[R] cream, a broad-spectrum antimicrobial agent, had been applied to one infant prior to enrollment.