Interdigital Tinea Pedis
Conditions
Keywords
Tinea Pedis, Interdigital
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 interdigital tinea pedis, and to show the superiority of the active treatments over that of the placebo (vehicle).
Interventions
DRUGButenafine Hydrochloride 1%
Twice daily application for 7 days
DRUGButenafine Hydrochloride 1% B
Twice daily application for 7 days
DRUGVehicle A
Twice daily application for 7 days
DRUGVehicle B
Twice daily application for 7 days
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant, non lactating females 18 years of age or older. 2. Signed informed consent form, which meets all criteria of current FDA regulations and the requirements of the India regulatory authorities. 3. If female and of child bearing potential, have a negative urine pregnancy test at the baseline visit, 4. A total score of at least six (6) for the following eight (8) clinical signs and symptoms of interdigital tinea pedis: fissuring, erythema, maceration, vesiculation, desquamation/scaling, exudation, pruritus, burning/stinging. In addition the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for either pruritus or desquamation/scaling 5. A confirmed clinical diagnosis of interdigital tinea pedis. 6. The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination (potassium hydroxide mount preparation). 7. Identification of an appropriate dermatophyte by culture sent to the central laboratory. The appropriate dermatophytes are Trichophyton rubrum, Trichophyton mentagrophytes or Epidermophyton floccosum.
Exclusion criteria
1. Use of any of the following within the indicated timeline: * Oral or injectable steroids within four weeks of the study start. * 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 OTC topical antifungal on the feet within two weeks prior to study entry. * Use of any antihistamines within 72 hours of the study start. 2. Any known hypersensitivity to butenafine or other antifungal agents. 3. Evidence of any concurrent dermatophytic infection of toe nails (onychomycosis) or other dermatological condition of the foot that may interfere with the Investigators evaluation of tinea pedis. 4. Patients with recurrent tinea pedis (more than 3 infections in the past 12 months) who have been unresponsive to previous antifungal therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Cure | 42 Days | Patients with clinical cure and mycologic cure are considered therapeutic cures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | 42 days | Patient will be considered a clincal cure if the score for erythema is equal or less than 2 and the total score for all of the other seven signs and symptoms is less than 2. |
| Mycologic Cure | 42 Days | Patient will be considered a mycological cure if the results of both the potassium hydroxide (KOH) and the fungal culture are negative. |
Outcome results
None listed