Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

Completed · Phase 1

Conditions studied: Tinea Pedis

In brief

To demonstrate comparable safety and efficacy of Taro Pharmaceuticals Inc. butenafine hydrochloride cream 1% (test product) and Lotrimin Ultra® cream (reference listed drug) in the treatment of interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).

Key facts

Study ID

NCT00835510

Run by

Sun Pharmaceutical Industries, Inc.

People needed

548

Starts

2008-06-01

Expected to finish

2008-12-01

Last updated by the study team

2014-02-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• Investigator Site — Burbank, California, United States
• Investigator Site — San Diego, California, United States
• Investigator Site — Miami, Florida, United States
• Investigator Site — Martinez, Georgia, United States
• Investigator Site — Stockbridge, Georgia, United States
• Investigator Site — Clinton Township, Michigan, United States
• Investigator Site — Hickory, North Carolina, United States
• Investigator Site — Raleigh, North Carolina, United States
• Investigator Site — Salisbury, North Carolina, United States
• Investigator Site — Sylvania, Ohio, United States
• Investigator Site — Simpsonville, South Carolina, United States
• Investigator Site — Bristol, Tennessee, United States
• Investigator Site — Nashville, Tennessee, United States
• Investigator Site — College Station, Texas, United States
• Investigator Site — Houston, Texas, United States
• Investigator Site — San Antonio, Texas, United States
• Investigator Site — Belize City, Belize

Full record on ClinicalTrials.gov

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