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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00835510
• Date of registration: 30/01/2009
• Primary sponsor: Taro Pharmaceuticals USA
• Public title: Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
• Scientific title: A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
• Date of first enrolment: June 2008
• Target sample size: 548
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00835510
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Belize, United States

Contacts

• Name: Darin B Brimhall, DO FACP CPI
• Affiliation: Novum Pharmaceutical Research Services

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Tinea Pedis

Intervention(s)

Drug: Butenafine cream 1% manufactured by Taro

Drug: Butenafine Vehicle manufactured by Taro

Drug: Lotrimin Ultra (butenafine) 1%

Primary Outcome(s)

Therapeutic Cure - Superiority Analysis [Time Frame: 42 days]

Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra [Time Frame: 42 days]

Secondary Outcome(s)

Clinical Cure [Time Frame: 42 days]

Mycologic Cure [Time Frame: 42 days]

Safety and Adverse Event Profile [Time Frame: 42 days]

Therapeutic Cure [Time Frame: 7 days]

Secondary ID(s)

BTNF-0708

Source(s) of Monetary Support

Please refer to primary and secondary sponsors