Tinea Pedis
Conditions
Keywords
Tinea Pedis
Brief summary
The objective of this study is to demonstrate that Oxiconazole nitrate 1% topical cream is effective for the treatment of patients with moderate to severe Tinea pedis.
Interventions
Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days
DRUGOxiconazole Nitrate Cream 1% (Oxistat®)
Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days
DRUGPlacebo
Placebo applied to affected area once a day for 28 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
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant, non-lactating female, 12 years of age or older. 2. Signed informed consent form, which meets all criteria of current FDA regulations 3. 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, IUD, oral, transdermal, injected or implanted hormonal contraceptives)and (must have used the same product for at least 30 days prior to the study start and use the same product throughout the duration of the study), transdermal or implanted hormonal contraceptives} 4. A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot. (the non-interdigital lesions should not be hyperkeratotic i.e., characteristic of moccasin). 5. The presence of tinea pedis infection, confirm by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination.
Exclusion criteria
1. Females who are pregnant, or lactating or likely to become pregnant during the study. 2. Any known hypersensitivity to oxiconazole nitrate or other antifungal agents. 3. Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy (i.e. recurrent tinea pedis, more than 3 infections in the past 12 months, which were unresponsive to previous antifungal therapy). 4. Participation in a research study in the past 30 days prior to screening/randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Cure | Day 42 | Clinical & Mycological Cure at 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Cure | Day 42 | Proportion of patients considered a clinical cure at 6 weeks |
| Mycological Cure | Day 42 | Proportion of patients with both KOH & culture negative at 6 weeks |
Outcome results
None listed