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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01519752
Other study ID # OXZC 1102
Secondary ID
Status Completed
Phase Phase 1
First received January 19, 2012
Last updated January 19, 2014
Start date November 2011
Est. completion date November 2012

Study information

Verified date January 2014
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 661
Est. completion date November 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Outcome

Type Measure Description Time frame Safety issue
Primary Therapeutic Cure Clinical & Mycological Cure at 6 weeks Day 42 No
Secondary Clinical Cure Proportion of patients considered a clinical cure at 6 weeks Day 42 No
Secondary Mycological Cure Proportion of patients with both KOH & culture negative at 6 weeks Day 42 No
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05493488 - A Trial to Evaluate the Safety and Efficacy of DBI-001 Gel, DBI-002 Gel, and Aqueous Gel in Subjects With Tinea Pedis Phase 2
Completed NCT04883593 - A Study Comparing the Efficacy of TA103 and the Placebo Control in the Treatment of Interdigital Tinea Pedis. Early Phase 1
Terminated NCT02842021 - Efficacy and Safety of Product S2G6T-1in Patients With Symptomatic Inflammatory Interdigital Tinea Pedis Phase 2
Completed NCT01712360 - Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis Phase 4
Completed NCT00781664 - Cumulative Irritation Test Phase 1
Completed NCT03676686 - Study With Nåva Foot Cream in Patients With Tinea Pedis Interdigitalis N/A
Completed NCT03320486 - Non-inferiority Trial of Dapaconazole Versus Ketoconazole Phase 3
Completed NCT01580891 - Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis Phase 1
Completed NCT01353976 - Safety and Efficacy of Econazole Nitrate Foam 1% in Subjects With Tinea Pedis Phase 3
Completed NCT01349998 - Safety of a Topical Antifungal Treatment for Tinea Cruris, Tinea Pedis and Tinea Corporis Phase 3
Completed NCT04265521 - Study With BioCool Footcare in Subjects With Tinea Pedis Interdigitalis and Heel Cracks, Calluses and/or Dry Feet N/A
Completed NCT02633813 - BE Study of Naftifine HCL Phase 3
Recruiting NCT00856596 - Once a Day Topical Treatment for Athlete's Foot Fungus Inbetween the Toes in Males and Females Phase 3
Completed NCT00869336 - Multicenter Study of the Efficacy and Safety of Luliconazole Cream in Tinea Pedis (Athlete's Foot) Phase 2
Completed NCT00768599 - A Study of Econazole Foam 1% in Athlete's Foot Phase 2
Recruiting NCT00233493 - Spread of Dermatophytes Among Families N/A
Completed NCT03897257 - A Comparison Study of UHE-103 Cream in Subjects With Moccasin Type Tinea Pedis Phase 2
Completed NCT03129321 - Therapeutic Equivalence and Safety of Two Econazole Nitrate Cream, 1% Products in Tinea Pedis Phase 3
Completed NCT02335255 - Evaluate Safety and Efficacy of Naftifine Hydrochloride Gel 2% and Naftin® Gel 2% in Tinea Pedis Phase 1
Withdrawn NCT02606383 - Non-inferiority Phase III Trial Comparing Dapaconazole Cream 2% With Ketoconazole Cream 2% in Patients With Tinea Pedis Phase 3