The Japanese Society for Medical Mycology (JSMM) decided in 2002 to establish guidelines for the clinical evaluation of
antifungal agents. The JSMM committee presents here guidelines for the clinical evaluation of topical
antifungal agents in the dermatology field. Guidelines for the Clinical Evaluation of
Antibiotic Agents established by the Japanese Society of
Chemotherapy were referred to, and the diseases subjected to clinical evaluation include
tinea (
tinea pedis and
tinea glabrosa),
cutaneous candidiasis, and
pityriasis versicolor. Among superficial
mycoses,
tinea pedis is viewed as the pivotal disease because it is intractable and is the most common. Therefore, the clinical efficacy of
antifungal agents for external use in this condition should be established, and
tinea pedis is subjected to phase III clinical studies. If efficacy of the
antifungal agents is confirmed in the treatment of
tinea pedis, a comparative study need not necessarily be performed for
tinea glabrosa. If the number of patients is adequate for statistical analysis, a comparative study should be considered for both
cutaneous candidiasis and
pityriasis versicolor. However, if the number of patients is low, the efficacy of the agents should be evaluated based on their antifungal activity on pathogens and the results of open trials, and a comparative study is not necessarily performed for such diseases. The safety should be strictly evaluated.