Status:
COMPLETED
Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
Lead Sponsor:
Sun Pharmaceutical Industries, Inc.
Conditions:
Tinea Pedis
Eligibility:
All Genders
12+ years
Phase:
PHASE1
Brief Summary
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 interd...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
548 Patients enrolled
Trial Details
Trial ID
NCT00835510
Start Date
June 1 2008
End Date
December 1 2008
Last Update
February 4 2014
Active Locations (17)
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1
Investigator Site
Burbank, California, United States
2
Investigator Site
San Diego, California, United States
3
Investigator Site
Miami, Florida, United States
4
Investigator Site
Martinez, Georgia, United States