Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis
Evaluate the Safety and Efficacy of Naftifine Hydrochloride Cream 2% and Naftin® Cream 2% in Patients With Tinea Pedis
The objective of this study is to compare the efficacy and safety of the test formulation of
 Naftifine Hydrochloride Cream 2% to Naftin® (Naftifine Hydrochloride) 2% Cream in a 6 week
 study in patients with tinea pedis.
Inclusion Criteria:

 -  Male or non-pregnant, non-lactating females 18 years or older

 -  Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or
 predominantly interdigital, but may extend to other areas of the foot

 -  The presence of interdigital tinea pedis infection

 -  The sum of the clinical signs and symptoms scores of the target lesion is at least 4,
 including a minimum score of at least 2 for erythema and a minimum score of 2 for
 either scaling or pruritus

 Exclusion Criteria:

 -  Females who are pregnant, lactating or planning to become pregnant during the study
 period

 -  Use of antipruritics, including antihistamines within 72 hours prior to baseline visit

 -  Use of topical corticosteroids, antibiotics or antifungal therapies within two weeks
 prior to baseline visit

 -  Use of systemic corticosteroids, antibiotics or antifungal therapies within one month
 prior to baseline visit

 -  Use of oral terbinafine or itraconazole within two months prior to baseline visit

 -  Use of immunosuppressive medication or radiation therapy within three months prior to
 baseline visit

 -  Any known hypersensitivity to Naftifine Hydrochloride, or any component of the
 formulation

 -  Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface

 -  History of significant or current evidence of chronic infectious disease, system
 disorder, organ disorder, or other medical condition that would place undue risk by
 participation or could jeopardize the integrity of study evaluations

 -  Evidence of any concurrent dermatophytic infection of the toe nails or dermatological
 condition of the foot that may interfere with tinea pedis evaluation

 -  Past history of dermatophyte infections with a lack of response ot antifungal therapy