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Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis

NCT ID: NCT00802672

Last Updated: 2021-10-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

561 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2004-05-31

Brief Summary

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The objectives of this study were to demonstrate comparable safety and efficacy of Ciclopirox Olamine Cream (Test Product) and Ciclopirox Cream 0.77% (Reference Product) in the treatment of subjects with tinea pedis, and to show the superiority of the active treatments over that of the vehicle.

Detailed Description

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Conditions

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Tinea Pedis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Test Product

Ciclopirox Olamine Cream 0.77%

Group Type EXPERIMENTAL

Ciclopirox Olamine Cream

Intervention Type DRUG

topical cream

Reference Product

Loprox Cream 0.77%

Group Type ACTIVE_COMPARATOR

Loprox Cream 0.77%

Intervention Type DRUG

topical cream

Vehicle Product

placebo of test product

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

topical cream

Interventions

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Ciclopirox Olamine Cream

topical cream

Intervention Type DRUG

Loprox Cream 0.77%

topical cream

Intervention Type DRUG

Placebo

topical cream

Intervention Type DRUG

Other Intervention Names

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Loprox Cream

Eligibility Criteria

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Inclusion Criteria

* Male or female at least 10 years of age, and otherwise healthy
* Clinically and mycologically confirmed diagnosis of symptomatic tinea pedis
* In good health with no clinically significant disease that might have interfered with study evaluations
* Study participant or legal guardian was willing and able to read and sign an IRB approved ICF, which included agreement to comply with all study requirements as indicated in the protocol. For subjects 10 to 17 years of age, an assent form for minors was completed.

Exclusion Criteria

* History of hypersensitivity or allergy to ciclopirox
* Had any skin condition that would interfere with the diagnosis or assessment of tinea pedis
* Had a history of dermatophyte infecton unresponsive to antifungal treatment
* Had a history of alcoholism, drug abuse, or problems that would likely have made the subject unreliable for the study
* Had any condition or used any medication that, in the opinion of the Investigator, might have interfered with the conduct or results of the study or placed the prospective subject at increased risk
* Was unwilling to sign the informed consent
* Female who was pregnant or lactating
Minimum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Padagis LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CPL-302

Identifier Type: -

Identifier Source: org_study_id