Phase 1
N=548
Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis
Tinea Pedis
Bottom Line
View on ClinicalTrials.gov: NCT00835510 ↗Enrolled (actual)
548
Serious AEs
—
Results posted
Oct 2009
Primary outcome: Primary: Therapeutic Cure - Superiority Analysis — 76; 108; 24 Participants — p=0.0127
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Butenafine cream 1% manufactured by Taro (Drug); Lotrimin Ultra (butenafine) 1% (Drug); Butenafine Vehicle manufactured by Taro (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Sun Pharmaceutical Industries, Inc.
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Therapeutic Cure - Superiority Analysis |
76; 108; 24 | 0.0127 sig |
| PRIMARY Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra |
63; 97 | — |
| SECONDARY Therapeutic Cure |
30; 38; 11 | — |
| SECONDARY Mycologic Cure |
101; 128; 33 | — |
| SECONDARY Clinical Cure |
83; 111; 27 | — |
| SECONDARY Safety and Adverse Event Profile |
— | — |
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 interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00835510). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.