W.F. YOUNG's OTC CHLOROXYLENOL EFFICACY IN TINEA PEDIS

Executive Summary

W.F. YOUNG's OTC CHLOROXYLENOL EFFICACY IN TINEA PEDIS has been demonstrated in a double-blind placebo controlled study of 58 patients, the firm maintained in a recent submission to FDA. The company reported that "84.6% of those subjects on active medication were cured," while 15.8% of those in the placebo group were cured. "At the 99.9% confidence level," the company said, "there was a significant difference between the active and placebo groups." W.F. Young explained that each subject applied 2% chloroxylenol or placebo to affected areas twice daily for 28 days. After two weeks, subjects were subjectively evaluated by the investigator for clinical signs and symptoms of athlete's foot. After an additional two weeks subjects were clinically evaluated, at which time skin scrapings were collected, a KOH preparation made, and culture performed. Subjects then went through a two week period without medication. At the end of the six week study subjects were further evaluated. A cure was defined as complete resolution of clinical signs and symptoms, a negative KOH and a negative culture. FDA's OTC Antimicrobial II Panel placed chloroxylenol in Category III and recommended that one double-blind placebo controlled clinical trial was necessary to establish efficacy of the product. The company noted anecdotally that four of the subjects also had onychomycosis, a fungal infection of the toenail. "In addition to evaluating the efficacy of [chloroxylenol] for athlete's foot, the subject's response to the product was evaluated vis-a-vis their toenail disease," W. F. Young stated. "Although no formal conclusion can be reached regarding this issue, it was the subjective impression that subjects were, in fact, responding to treatment of their toenails if the product given was also curing their athlete's foot."