Evaluation of the effectiveness of griseofulvin, tolnaftate, and placebo in the topical therapy of superficial dermatophytoses

Abstract

The efficacy of a topical formulation containing 2% micronized griseofulvin applied 3 times daily for 3 wk was evaluated in patients with superficial dermatophytoses. A double blind parallel study was designed to compare the formulation to a standard therapy (tolnaftate 1% cream) and a placebo ointment. One of the 3 preparations was assigned at random to a total of 52 subjects. Thirteen of 15 subjects treated with placebo ointment were judged to be treatment failures. Nine of 18 subjects treated with griseofulvin, and 9 of 19 subjects treated with tolnaftate, responded to treatment. Clinical response appeared to be related to the severity of the infection rather than to the anatomical location of the lesions. The results suggest that griseofulvin may be effective following topical application and demonstrate the usefulness of positive and negative controls when evaluating topical antifungal agents.