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

NCT01519752 | Completed Phase 1

• 1 other identifier: OXZC 1102
• Study Type: interventional
• Target: 661
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tinea Pedis

Keywords

Tinea Pedis

Outcome Measures

Primary Outcomes (1)

• Therapeutic Cure

  Clinical \& Mycological Cure at 6 weeks

  Day 42

Secondary Outcomes (2)

• Clinical Cure

  Day 42

• Mycological Cure

  Day 42

Study Arms (3)

Oxiconazole Nitrate Cream 1%

EXPERIMENTAL

Drug: Oxiconazole Nitrate Cream 1%

Oxiconazole Nitrate Cream 1% (Oxistat®)

ACTIVE COMPARATOR

Drug: Oxiconazole Nitrate Cream 1% (Oxistat®)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxiconazole Nitrate Cream 1% DRUG

Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days

Oxiconazole Nitrate Cream 1%

Oxiconazole Nitrate Cream 1% (Oxistat®) DRUG

Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days

Oxiconazole Nitrate Cream 1% (Oxistat®)

Placebo DRUG

Placebo applied to affected area once a day for 28 days

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-lactating female, 12 years of age or older.
• Signed informed consent form, which meets all criteria of current FDA regulations
• 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}
• 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).
• The presence of tinea pedis infection, confirm by the observation of segmented fungal hyphae during a microscopic KOH wet mount examination.

You may not qualify if:

• Females who are pregnant, or lactating or likely to become pregnant during the study.
• Any known hypersensitivity to oxiconazole nitrate or other antifungal agents.
• 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).
• Participation in a research study in the past 30 days prior to screening/randomization.

Sponsors & Collaborators

• Sun Pharmaceutical Industries, Inc.: lead

MeSH Terms

Conditions

Tinea Pedis

Interventions

oxiconazole

Condition Hierarchy (Ancestors)

Tinea; Dermatomycoses; Mycoses; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Foot Dermatoses; Foot Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pruritus; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: January 27, 2012
• Study Start: November 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2012
• Last Updated: January 22, 2014

Record last verified: 2014-01