Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sun Pharmaceutical Industries, Inc.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Microbiologically confirmed clinical diagnosis of interdigital tinea pedis
If female and of child bearing potential, prepare to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, intra-uterine device (IUD), oral, transdermal, injected or implanted hormonal contraceptives).
A confirmed clinical diagnosis of interdigital tinea pedis. Lesions are to be predominately interdigital but may extend to other areas of the foot (the non-interdigital lesions must not be hyperkeratotic).
The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic potassium hydroxide (KOH) wet mount examination (potassium hydroxide mount preparation).
Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophyte or Epidermophyton floccosum.
You may not be if
Use of any of the following within the indicated timeline:
Oral or injectable steroids
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 over-the-counter (OTC) topical antifungals on the feet within two weeks prior to study entry
Use of any antihistamines within 72 hours of the study start.
Any known hypersensitivity to butenafine or other antifungal agents.
Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigator's evaluation of tinea pedis.
Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
Clareo Health | Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
