The objective of this study is to evaluate the efficacy and safety of the test formulation
of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed
formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients
with tinea pedis and to show the superiority of the active treatments over placebo when
dosed once a day for 28 days.
Inclusion Criteria:
- Male or non-pregnant, non-lactating females 18 years of age or older.
- Signed informed consent form, which meets all criteria of current FDA regulations.
- If female and of child-bearing potential, have a negative urine pregnancy test at
baseline visit, and prepare to abstain from sexual intercourse or use a reliable
method of contraception during the study.
- A total score of at least 4 for the clinical signs and symptoms of tinea pedis for
the target lesion. In addition, the most infected area must have a minimum score of
at least 2 for erythema and a minimum score of at least 2 for scaling.
- A confirmed 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 tinea pedis infection, confirmed by the observation of segmented
fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.
Exclusion Criteria:
- Females who are pregnant, lactating or likely to become pregnant during the study.
- 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 HCl, any component of the formulation or
other antifungal agents.
- Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
- Significant history or current evidence of chronic infectious disease, system
disorder, organ disorder, or other medical condition that would place the 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 evaluation of tinea pedis.
- Patients with a past history of tinea pedis infections with a lack of response to
antifungal therapy.
- Patients who would be non-compliant with the requirements of the study protocol.
- Participation in a research study within 30 days prior to baseline visit.
- Employees or family members of employees of the research center or investigator.
- Previous participation in this study.
