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FISONS SEEKING DESENEX PROPHYLACTIC CLAIM FOR ATHLETE’s FOOT

Executive Summary

FISONS SEEKING DESENEX PROPHYLACTIC CLAIM FOR ATHLETE's FOOT, according to recent correspondence between FDA and the company over a protocol to support the claim. "Our intent is to do a study for the powder dosage form of the current Desenex marketed product," Fisons Senior Regulatory Affairs Associate Joyce Miller told FDA. The company intends "to utilize this information, if positive, to support a prophylactic claim for all dosage forms currently marketed by Fisons," the regulatory affairs officer added. The company's suggested protocol to demonstrate the effectiveness of undeyclenates in the prevention of athlete's foot calls for a twelve-week, double-blinded parallel group clinical study. The medication will applied to all surfaces of the foot: toes and plantar surface. Test subjects are to have a history of athlete's foot, "defined as that elicited by questioning the patient wherein the patient by history has experienced two incidences of athlete's foot in the past 12 months and has previously experienced relief of signs and symptoms of their athlete's foot condition by use of over-the-counter medication." FDA has asked Fisons to further confirm a previous experience of athlete's foot in a test subject with a KOH preparation and culture of skin scrapings. Similarly, to evaluate effectiveness, equal weight will be placed on (1) signs and symptom scores and (2) KOH preparations and culture of skin scrapings. FDA has requested Fisons to "include a representative number of patients with a past history of interdigital as well as plantar type tinea pedis with the data analyzed for each subset and as a whole."

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