TREATMENT OF TINEA-UNGUIUM WITH MEDIUM AND HIGH-DOSES OF ULTRAMICROSIZE GRISEOFULVIN COMPARED WITH THAT WITH ITRACONAZOLE

Toenail tinea is a very recalcitrant dermatosis. Griseofulvin at great er-than-or-equal-to 500 mg/day is the current medication of choice, bu t it is minimally successful. In a controlled open trial ultramicrosiz e griseofulvin (UMSG) at doses of 660 and 990 mg/day was compared with itraconazole at 100 mg/day in 109 patients. At 4-week intervals, the patients were evaluated for their clinical and mycological statuses an d adverse reactions. Treatment was given for up to 18 months. Complian ce was checked by tablet counting. Response (cure, partial cure, marke d improvement) was analyzed by the intent-to-treat method. Cured and p artially cured patients were followed up. Except for one early dropout , the toenails (mean, 6 to 7) were involved. Cure or partial cure was found in 6% (UMSG at 660 mg), 14% (UMSG at 990 mg), and 19% (itraconaz ole at 100 mg) of patients (P = 0.2097); marked improvement was found in 36, 44, and 39% of patients in the three treatment groups, respecti vely. Most patients had to be treated for 18 months. Failure was relat ed to short medication periods (adverse drug reactions, dropout). Whil e stable cure was not obtained with UMSG at 660 mg, the higher dose of UMSG and itraconazole gave stable cures in the other patients. Side e ffects of nausea, diarrhea, and headache were found in 20, 26, and 11 patients, respectively (P = 0.0028), and the numbers in whom medicatio n had to be discontinued differed, too (P = 0.0137). While there was n o major difference with glutamic-pyruvic transaminase and gamma-GT, to tal and low-density lipoprotein cholesterol levels declined slightly i n the itraconazole group (P = 0.0357 and P = 0.0639, respectively, at 3 months). More than 70% of the patients had an average compliance of greater-than-or-equal-to 90%; four patients (two dropouts) were poor c ompliers. In conclusion, it appears questionable whether griseofulvin can continue to be considered the ''gold standard'' in the treatment o f toenail tinea. At present, itraconazole at 100 m shows better effica cy and is better tolerated.