Evaluate the Safety & Bioequivalence of a Generic Butenafine Cream & Lotrimin Ultra® & Compare Both to a Vehicle Control in Treatment of Interdigital Tinea Pedis

This is an interventional treatment trial for Tinea Pedis focused on measuring Butenafine Hydrochloride Cream, 1%, Lotrimin Ultra® Cream, 1%, Interdigital Tinea Pedis, Safety and Bioequivalence Read More

Inclusion Criteria:

• Willing & able to provide & understand written informed consent
• Healthy male or non-pregnant, non-lactating female at least 18 years of age and older
• Clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or that is predominantly interdigital but may extend to other areas
• Tinea pedis provisionally confirmed at baseline by positive potassium hydroxide (KOH)wet mount preparation showing segmented fungal hyphae
• Has sum of the clinical signs and symptoms scores of the target lesion of at least 4, including a minimum score of 2 for erythema & a minimum score of 2 for scaling or pruritus
• Currently in general good health with no clinically significant disease
• Willing and able to understand and comply with study requirements
• Women of childbearing potential must have a negative urine pregnancy test and be willing to use an acceptable form of birth control during study

Exclusion Criteria:

• Females who are pregnant, breastfeeding, planning a pregnancy, or do not agree to use an acceptable form of birth control during the study
• Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface
• Presence of any other infection of the foot or other disease that might confound treatment evaluation
• History of dermatophyte infections unresponsive to antifungal drugs
• Known hypersensitivity to Butenafine Hydrochloride or any component of the study medications
• Use of antipruritics, topical systemic corticosteroid, antibiotic or antifungal therapy, oral terbinafine or itraconazole, or immunosuppressive medication or radiation therapy more recently than indicated washout period
• Current oral, vaginal, or mucocutaneous candidiasis
• Current bacterial skin infection, secondary cellulitis, lymphangitis, or pyoderma
• Presence of current conditions that require systemic antimicrobial or antifungal therapy
• Uncontrolled diabetes mellitus, peripheral vascular disease, chronic venous stasis, or other significant condition
• Current severe onychomycosis
• Any clinically significant condition or situation, other than condition being studied, that would interfere with the study evaluations or participation
• Use of any investigational drugs or device within 30 days of signing Informed Consent Form (ICF)
• Current participation in any other clinical study
• Consumes excessive amounts of alcohol, abuses drugs, or has any condition that would compromise compliance
• Previous participation in this study
• Subjects with past history of tinea pedis with lack of response to antifungal therapy
• Subjects who in Investigator's opinion would be non-compliant
• Employees or direct relatives of an employee of the study center or Investigator