Twenty white children (8 girls; 12 boys), ranging in age from 2 to 12 years (most in the age range 5-9 years), were enrolled in a clinical trial with their parents consent to assess the efficacy, safety, and tolerability of a single oral dose of fluconazole given once weekly for 4-8 weeks for the treatment of outpatients with mycologically proven tinea capitis.
Ten children had previously undergone an unsuccessful course of treatment with griseofulvin liquid suspension or the ultramicronized formulation and desired alternative therapy. Factors possibly contributing to the lack of success of griseofulvin included living in a tropical area, poor hygiene, insufficient dosages, and malnutrition. Adverse reactions to griseofulvin included skin eruption, nausea, photosensitivity, and drug interactions. Furthermore, the patients became exasperated with the long duration of griseofulvin therapy.
The diagnosis of tinea capitis was confirmed on the basis of microscopic examination of arthrospores of the infecting fungus located outside or inside the affected hairs. The primary isolation of the causative pathogens in culture was accomplished using Mycosel (BBL, Baltimore, MD) and Sabouraud dextrose agar. The pathogens recovered were Microsporum canis (13), M. gypseum (5), and Trichophyton tonsurans (2). All cases caused by M. canis were positive under Wood's light.
Patients underwent a physical examination, laboratory tests were performed, and a medical history was obtained from the mother or father of each patient. Any medications taken by the patients at study entry or during the study were recorded.
Fluconazole therapy was administered once a week in the presence of the investigator. The dosage was based on body weight. Initially, the fluconazole dose was 6 mg/kg. The dose subsequently was increased to 8 mg/kg based on safety information, including laboratory test results. All patients, except for four, were treated at the higher dose. Shampoos were not used as adjunctive therapy.
Patients were assessed weekly for clinical and mycologic response and for the occurrence of adverse events. Adverse event information included the date of onset, duration, severity, and relationship to drug therapy.