A Therapeutic Equivalence Study of Two Oxiconazole Nitrate Topical Cream Treatments for Patients With Tinea Pedis

Taro Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Tinea Pedis

Treatments: Drug: Placebo; Drug: Oxiconazole Nitrate Cream 1%; Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01519752

OXZC 1102

Details and patient eligibility

About

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.

Enrollment: 661 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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661 participants in 3 patient groups, including a placebo group

Oxiconazole Nitrate Cream 1%

Experimental group

Treatment:

Drug: Oxiconazole Nitrate Cream 1%

Oxiconazole Nitrate Cream 1% (Oxistat®)

Active Comparator group

Treatment:

Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo