A Multi-Center, Double-Blind Comparison of Ketoconazole and Griseofulvin in the Treatment of Infections Due to Dermatophytes

The efficacy and safety of daily doses of 200 mg of ketoconazole or 250 mg of griseofulvin (Fulvicin-P/G®, Schering, Kenilworth, N.J.) in the treatment of patients with infections due to dermatophytes are being evaluated in a three-center study. Patients with chronic dermatomycoses resistant to topi...

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Bibliographic Details
Published in:Reviews of infectious diseases 1980-07, Vol.2 (4), p.586-591
Main Authors: Legendre, R, Steltz, M
Format: Article
Language:English
Subjects:
Adverse effects
Dermatomycoses
Dermatomycoses - drug therapy
Dermatophytes
Double-Blind Method
Fungi
Griseofulvin - therapeutic use
Humans
Imidazoles - adverse effects
Imidazoles - therapeutic use
Infections
Ketoconazole
Lesions
Piperazines - adverse effects
Piperazines - therapeutic use
Session III: Dermatomycoses
Tinea
Tinea - drug therapy
Tinea pedis
Tissue samples
Trichophyton - drug effects
Writing tablets
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Summary:The efficacy and safety of daily doses of 200 mg of ketoconazole or 250 mg of griseofulvin (Fulvicin-P/G®, Schering, Kenilworth, N.J.) in the treatment of patients with infections due to dermatophytes are being evaluated in a three-center study. Patients with chronic dermatomycoses resistant to topical treatment or with infections that involve large areas of the body, a condition that indicates oral therapy, are being treated for a minimum of four weeks. Eleven (38%) of 29 patients treated with ketoconazole for four weeks and five (24%) of 21 patients treated with griseofulvin for the same amount of time were rated as cured. At completion of therapy (four to eight weeks), 24 (83%) of 29 patients treated with ketoconazole and six (32%) of 19 patients treated with griseofulvin were rated as cured (P = < 0.001). One (7%) of 14 patients treated with ketoconazole and four (80%) of five patients treated with griseofulvin were rated as relapsed within 28 days after completion of therapy (P = 0.006). No significant adverse effects have been reported for either treatment group. The preliminary results of this study have shown ketoconazole to be more effective than griseofulvin in the treatment of dermatomycoses. /// La eficacia y la seguridad de dosis diarias de 200 mg de ketoconazol o de 250 mg de griseofulvina (Fulvicin-P/G®, Schering, Kenilworth, N.J.), en el tratamiento de pacientes con infecciones debidas a dermatofitos, están siendo evaluadas en un estudio que abarca tres centros diferentes. Pacientes que presentan una dermatofitosis crónica, resistente al tratamiento tópico o que tienen compromiso de áreas extensas del cuerpo, condición que indica la necesidad de terapia oral, están siendo tratados por un período mínimo de cuatro semanas. Once (38%) de 29 pacientes tratados con ketoconazol por cuatro semanas y cinco (24%) de 21 tratados con griseofulvina por el mismo período, fueron considerados curados. A la terminación de la terapia (cuatro a ocho semanas), 24 (83%) de 29 y seis (32%) de 19 de los pacientes tratados con ketoconazol y griseofulvina, respectivamente, fueron considerados curados (P = < 0.001). Un paciente (7%) de los 14 tratados con ketoconazol y cuatro (80%) de los cinco tratados con griseofulvina recayeron dentro de los 28 días siguientes a la terminación de la terapia (P = 0.006). No se reportaron efectos adversos en ninguno de los dos grupos terapeúticos. Los resultados preliminares de este estudio han revelado que el ketoconazol es más e
ISSN:0162-0886