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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

Primary Purpose

Tinea Pedis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Ciclopirox Olamine Cream
Loprox Cream 0.77%
Placebo
Sponsored by
Padagis LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinea Pedis focused on measuring Tinea Pedis, Ciclopirox Olamine

Eligibility Criteria

10 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Test Product

    Reference Product

    Vehicle Product

    Arm Description

    Ciclopirox Olamine Cream 0.77%

    Loprox Cream 0.77%

    placebo of test product

    Outcomes

    Primary Outcome Measures

    Proportion of Subjects in Each Treatment Group With Therapeutic Success
    Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success

    Secondary Outcome Measures

    Proportion of Subjects With Mycological Cure
    Mycological Cure (KOH wet mount negative and fungal culture negative
    Proportion of Subjects With Clinical Cure
    Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis

    Full Information

    First Posted
    December 4, 2008
    Last Updated
    October 11, 2021
    Sponsor
    Padagis LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00802672
    Brief Title
    Safety and Equivalence of a Generic Ciclopirox Olamine Cream Compared to the Reference Ciclopirox Cream 0.77% for the Treatment of Tinea Pedis
    Official Title
    A Double-blind, Randomized, Parallel-group, Vehicle-controlled, Multi-center Study to Evaluate the Safety and Clinical Equivalence of a Generic Ciclopirox Olamine Cream to Ciclopirox Cream 0.77% in the Treatment of Tinea Pedis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    May 2004 (Actual)
    Study Completion Date
    May 2004 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Padagis LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinea Pedis
    Keywords
    Tinea Pedis, Ciclopirox Olamine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    561 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Test Product
    Arm Type
    Experimental
    Arm Description
    Ciclopirox Olamine Cream 0.77%
    Arm Title
    Reference Product
    Arm Type
    Active Comparator
    Arm Description
    Loprox Cream 0.77%
    Arm Title
    Vehicle Product
    Arm Type
    Placebo Comparator
    Arm Description
    placebo of test product
    Intervention Type
    Drug
    Intervention Name(s)
    Ciclopirox Olamine Cream
    Intervention Description
    topical cream
    Intervention Type
    Drug
    Intervention Name(s)
    Loprox Cream 0.77%
    Other Intervention Name(s)
    Loprox Cream
    Intervention Description
    topical cream
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    topical cream
    Primary Outcome Measure Information:
    Title
    Proportion of Subjects in Each Treatment Group With Therapeutic Success
    Description
    Both Mycological Cure (KOH wet mount negative and fungal culture negative) and Clinical Cure were required to achieve Therapeutic Success
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    Proportion of Subjects With Mycological Cure
    Description
    Mycological Cure (KOH wet mount negative and fungal culture negative
    Time Frame
    6 weeks
    Title
    Proportion of Subjects With Clinical Cure
    Description
    Clinical Cure was defined as a signs and symptoms score of <1 for erythema; <1 for scaling; and 0 for pruritus, maceration, fissuring/cracking, and burning/stinging; as well as an assessment that no additional antifungal therapy was required to treat the subject's current episode of tinea pedis
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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