None listed
Conditions
Interventions
Intervention1: Butenafine Hydrochloride 1%: treated twice daily for 7 days
Control Intervention1: Lotrimin Ultra®
cream.: treated twice daily for 7 days
Sponsors
Taro Pharmaceuticals USA, Inc. 3 Skyline Drive Hawthorne, NY 10532 (914)345-9001
Trident Clinical Research India Pvt. Ltd. Office No. 4, 3rd Floor, BIZ Park, Road No 16U, Wagle Estate, MIDC, Thane (W)- 400604, Maharashtra, India.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males and femalepatients with age 18 years of age or older. 2. Signed informed consent form, which meets all criteria of current DCGI and FDA regulations. 3. If female and of child bearing potential, has a negative urine pregnancy test at the baseline visit 4. A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. 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 either pruritus or desquamation/scaling. 5. A confirmed clinical diagnosis of interdigital tinea pedis. 6. The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination and fungal culture test
Exclusion criteria
Exclusion criteria: 1. Use of any of the following within the indicated timeline: # Oral or injectable steroids within four weeks of the study start. # Any oral anti-fungals within 4 weeks of the study start # Use of topical corticosteroids or any other topical antipruritics on the feet within 72 hours of the study start. # Any prescription or OTC topical antifungals on the feet within two weeks prior to study entry # Use of any antihistamines within 72 hours of the study start. 2. Any known hypersensitivity to butenafine or other antifungal agents. 3. Females who are pregnant, lactating or likely to become pregnant during the study. 4. Significant history or current evidence of chronic infectious disease, system disorder, organ disorder or other medical condition, 5. Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition 6. Patients with recurrent tinea pedis 7. Noncompliance of protocol 8. Receipt of any drug as part of a research study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the clinical and mycological efficacyTimepoint: Day 7 and day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| to compare the adverse event profileTimepoint: day 7 and day 42 | — |
Countries
India
Contacts
Public ContactDr. Samir Sadekar
Project Manager
Outcome results
None listed