Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis
Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis
To compare the efficacy and safety of the test formulation Naftifine Hydrochloride Gel 2% to
 Naftin® (Naftifine Hydrochloride) Gel 2%
The purpose of this study is to compare the efficacy and safety of the test formulation
 Naftifine Hydrochloride Gel 2% to Naftin® (Naftifine Hydrochloride) Gel 2% in a six week
 study (four weeks after the end of two week treatment) in patients with tinea pedis.
Inclusion Criteria:

 -  Male or non-pregnant, non-lactating females 18 years of age or older.

 -  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.

 -  Clinical diagnosis of interdigital 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, confirmed by the observation of
 segmented fungal hyphae during a microscopic potassium hydroxide wet mount
 preparation.

 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 2 weeks
 prior to baseline visit.

 -  Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month
 prior to baseline visit.

 -  Use of oral Terbinafine or Itraconazole within 2 months prior to baseline visit.

 -  Use of immunosuppressive medication or radiation therapy within 3 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 patient at undue
 risk by participation or could jeopardize the integrity of the study evaluations.

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

 -  Patients with a past history of dermatophyte infections with a lack of response to
 antifungal therapy.