Clinical Drug Experience Knowledgebase

Criteria

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